Covid19, Anosmia, Fever, Cough, Shortness of Breath, Sore Throat, Nausea, Vomiting, Headache, Muscle Weakness, Pain, Muscle, Pain, Chest, Pain, Joint, Pain, Abdominal, Pain, Irritable Mood, Confusion
Conditions
Brief summary
The main aim of this study is to determine the effects of short-term treatment with hesperidin on COVID-19 symptoms in comparison with a placebo. Treatment effects will be observed through a symptoms diary that will be completed by participants throughout the study and by taking the oral temperature daily.
Detailed description
This will be a randomized, double-blind, placebo-controlled study. The study will include subjects from Quebec diagnosed with COVID-19 infections. Following informed consent, 216 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either hesperidin 1000 mg once daily (q.d.)) or placebo (1:1 allocation ratio) for 14 days. Investigational drug will be delivered to the patients' homes with an electronic oral thermometer and a symptoms diary. Follow-up phone assessments will occur after 3, 7, 10, and 14 days following randomization for evaluation of COVID-19 symptoms. Electronic Case Report Form (eCRF) will be completed by the research personnel over the phone with the patients. The symptoms diary will be mailed back to the coordinating center at the end of the study in a pre-addressed envelope.
Interventions
DRUGHesperidin
Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
DRUGPlacebo
Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
Sponsors
Ingenew Pharmaceuticals Inc.
Montreal Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Covid-19 positive by polymerase chain reaction (PCR) testing; * Participant must be able to evaluate their symptoms and report them in the symptoms diary; * Patients must be able to take their oral temperature daily with an electronic thermometer provided to them with study materials; * Males and females, at least 18 years of age, capable and willing to provide informed consent; * Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study; * Patient must have received a diagnosis of COVID-19 infection within the last 48 hours and have one or more symptoms; * Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization); * Patient must be able and willing to comply with the requirements of this study protocol.
Exclusion criteria
* Patient currently hospitalized or under immediate consideration for hospitalization; * Patient currently in shock or with hemodynamic instability; * Patient undergoing chemotherapy for cancer; * Patient is unable to take oral temperature using an electronic thermometer; * Patient who received at least one dose of the COVID-19 vaccine; * Female patient who is pregnant or breast-feeding or is considering becoming pregnant during the study; * People taking anticoagulant/antiplatelet medications, those with bleeding disorders, and people two weeks before or after surgery; * Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study; * Regular consumption of natural products containing more than 150 mg of hesperidin or regular consumption of more than 1 glass of orange juice per day; * Known allergy to any of the medicinal and non-medicinal ingredient: hesperidin, microcrystalline cellulose, magnesium stearate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With COVID-19 Symptoms at Day 3. | Day 3 | Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 3. |
| Number of Subjects With COVID-19 Symptoms at Day 7. | Day 7 | Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 7. |
| Number of Subjects With COVID-19 Symptoms at Day 10. | Day 10 | Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 10. |
| Number of Subjects With COVID-19 Symptoms at Day 14. | Day 14 | Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 14. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Complete Disappearance of Any Symptom. | From randomization to occurence of first event, assessed up to 14 days | The descriptive statistics are the number of participants having complete disappearance of any symptom. |
| Number of Subjects With the Cough Symptom. | Day 3 | Number of subjects with the cough symptom at day 3. |
| Number of Subjects With the Presence of Fever. | Day 3 | Number of subjects with the presence of fever (temperature \> 38 degrees) at day 3. |
| Number of Subjects With the Presence of Shortness of Breath. | Day 3 | Number of subjects with the presence of shortness of breath at day 3. |
| Number of Subjects With the Presence of Anosmia. | Day 3 | Number of subjects with the presence of anosmia at day 3. |
| Number of Subjects With the Presence of Feverish or Chills. | Day 3 | Number of subjects with the presence of feverish or chills at day 3. |
| Number of Subjects With the Presence of Sore Throat. | Day 3 | Number of subjects with the presence of sore throat at day 3. |
| Mean Number of COVID-19 Symptoms at Day 14. | Day 14 | Mean number of COVID-19 symptoms (range 0-13) at day 14. |
| Number of Subjects With the Presence of Nausea/Vomiting. | Day 3 | Number of subjects with the presence of nausea/vomiting at day 3. |
| Number of Subjects With the Presence of Headache. | Day 3 | Number of subjects with the presence of headache at day 3. |
| Number of Subjects With the Presence of General Weakness. | Day 3 | Number of subjects with the presence of general weakness at day 3. |
| Number of Subjects With the Presence of Pain. | Day 3 | Number of subjects with the presence of pain at day 3. |
| Number of Subjects With the Presence of Irritability/Confusion. | Day 3 | Number of subjects with the presence of irritability/confusion at day 3. |
| Number of Subjects With the Presence of Diarrhea. | Day 3 | Number of subjects with the presence of diarrhea at day 3. |
| Number of Subjects With the Presence of Runny Nose. | Day 3 | Number of subjects with the presence of runny nose at day 3. |
| Mean Number of COVID-19 Symptoms at Day 3. | Day 3 | Mean number of COVID-19 symptoms (range 0-13) at day 3. |
| Mean Number of COVID-19 Symptoms at Day 7. | Day 7 | Mean number of COVID-19 symptoms (range 0-13) at day 7. |
| Mean Number of COVID-19 Symptoms at Day 10. | Day 10 | Mean number of COVID-19 symptoms (range 0-13) at day 10. |
Countries
Canada
Participant flow
Recruitment details
216 subjects were randomized into the study with 109 assigned to placebo and 107 to hesperidin.
Participants by arm
| Arm | Count |
|---|---|
| Hesperidin 1000mg Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water. | 107 |
| Placebo 1000mg Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water. | 109 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo 1000mg | Total | Hesperidin 1000mg |
|---|---|---|---|
| Age, Continuous | 40.67 years STANDARD_DEVIATION 11.26 | 40.98 years STANDARD_DEVIATION 12.14 | 41.31 years STANDARD_DEVIATION 13.02 |
| Asthma With Asthma | 17 Participants | 31 Participants | 14 Participants |
| Asthma Without Asthma | 92 Participants | 185 Participants | 93 Participants |
| Body Mass Index (BMI) | 28.21 KG/m^2 STANDARD_DEVIATION 6.82 | 28.16 KG/m^2 STANDARD_DEVIATION 6.59 | 28.12 KG/m^2 STANDARD_DEVIATION 6.38 |
| Chronic Obstructive Pulmonary Disease (COPD) With COPD | 1 Participants | 1 Participants | 0 Participants |
| Chronic Obstructive Pulmonary Disease (COPD) Without COPD | 108 Participants | 215 Participants | 107 Participants |
| Diabetes With Diabetes | 1 Participants | 7 Participants | 6 Participants |
| Diabetes Without Diabetes | 108 Participants | 209 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 105 Participants | 209 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hypertension With Hypertension | 9 Participants | 23 Participants | 14 Participants |
| Hypertension Without Hypertension | 100 Participants | 193 Participants | 93 Participants |
| Other Respiratory Disease With Other Respiratory Disease | 1 Participants | 1 Participants | 0 Participants |
| Other Respiratory Disease Without Other Respiratory Disease | 108 Participants | 215 Participants | 107 Participants |
| Pulmonary Fibrosis Without Pulmonary Fibrosis | 109 Participants | 215 Participants | 106 Participants |
| Pulmonary Fibrosis With Pulmonary Fibrosis | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 107 Participants | 209 Participants | 102 Participants |
| Respiratory Disease Without Respiratory Disease | 91 Participants | 183 Participants | 92 Participants |
| Respiratory Disease With Respiratory Disease | 18 Participants | 33 Participants | 15 Participants |
| Sex: Female, Male Female | 60 Participants | 119 Participants | 59 Participants |
| Sex: Female, Male Male | 49 Participants | 97 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 107 | 0 / 109 |
| other Total, other adverse events | 20 / 107 | 16 / 108 |
| serious Total, serious adverse events | 4 / 107 | 1 / 108 |
Outcome results
Primary
Number of Subjects With COVID-19 Symptoms at Day 10.
Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 10.
Time frame: Day 10
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With COVID-19 Symptoms at Day 10. | Subject has at least one of the selected COVID-19 symptoms. | 58 Participants |
| Hesperidin 1000mg | Number of Subjects With COVID-19 Symptoms at Day 10. | Subject has none of the selected COVID-19 symptoms. | 32 Participants |
| Placebo 1000mg | Number of Subjects With COVID-19 Symptoms at Day 10. | Subject has at least one of the selected COVID-19 symptoms. | 60 Participants |
| Placebo 1000mg | Number of Subjects With COVID-19 Symptoms at Day 10. | Subject has none of the selected COVID-19 symptoms. | 39 Participants |
p-value: 0.588695% CI: [0.65, 2.14]Mixed Models Analysis
Primary
Number of Subjects With COVID-19 Symptoms at Day 14.
Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 14.
Time frame: Day 14
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With COVID-19 Symptoms at Day 14. | Subject has at least one of the selected COVID-19 symptoms. | 39 Participants |
| Hesperidin 1000mg | Number of Subjects With COVID-19 Symptoms at Day 14. | Subject has none of the selected COVID-19 symptoms. | 40 Participants |
| Placebo 1000mg | Number of Subjects With COVID-19 Symptoms at Day 14. | Subject has at least one of the selected COVID-19 symptoms. | 55 Participants |
| Placebo 1000mg | Number of Subjects With COVID-19 Symptoms at Day 14. | Subject has none of the selected COVID-19 symptoms. | 39 Participants |
p-value: 0.232895% CI: [0.38, 1.27]Mixed Models Analysis
Primary
Number of Subjects With COVID-19 Symptoms at Day 3.
Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 3.
Time frame: Day 3
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With COVID-19 Symptoms at Day 3. | Subject has at least one of the selected COVID-19 symptoms. | 93 Participants |
| Hesperidin 1000mg | Number of Subjects With COVID-19 Symptoms at Day 3. | Subject has none of the selected COVID-19 symptoms. | 9 Participants |
| Placebo 1000mg | Number of Subjects With COVID-19 Symptoms at Day 3. | Subject has at least one of the selected COVID-19 symptoms. | 90 Participants |
| Placebo 1000mg | Number of Subjects With COVID-19 Symptoms at Day 3. | Subject has none of the selected COVID-19 symptoms. | 13 Participants |
p-value: 0.384995% CI: [0.6, 3.69]Mixed Models Analysis
Primary
Number of Subjects With COVID-19 Symptoms at Day 7.
Number of subjects with any of the following COVID-19 symptoms: fever (temperature \> 38 degrees), cough, shortness of breath or anosmia, at day 7.
Time frame: Day 7
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With COVID-19 Symptoms at Day 7. | Subject has at least one of the selected COVID-19 symptoms. | 74 Participants |
| Hesperidin 1000mg | Number of Subjects With COVID-19 Symptoms at Day 7. | Subject has none of the selected COVID-19 symptoms. | 17 Participants |
| Placebo 1000mg | Number of Subjects With COVID-19 Symptoms at Day 7. | Subject has at least one of the selected COVID-19 symptoms. | 76 Participants |
| Placebo 1000mg | Number of Subjects With COVID-19 Symptoms at Day 7. | Subject has none of the selected COVID-19 symptoms. | 25 Participants |
p-value: 0.313995% CI: [0.71, 2.88]Mixed Models Analysis
Secondary
Mean Number of COVID-19 Symptoms at Day 10.
Mean number of COVID-19 symptoms (range 0-13) at day 10.
Time frame: Day 10
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hesperidin 1000mg | Mean Number of COVID-19 Symptoms at Day 10. | 2.01 Symptoms | Standard Deviation 2.19 |
| Placebo 1000mg | Mean Number of COVID-19 Symptoms at Day 10. | 1.95 Symptoms | Standard Deviation 2.12 |
p-value: 0.82995% CI: [0.78, 1.37]Mixed Models Analysis
Secondary
Mean Number of COVID-19 Symptoms at Day 14.
Mean number of COVID-19 symptoms (range 0-13) at day 14.
Time frame: Day 14
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hesperidin 1000mg | Mean Number of COVID-19 Symptoms at Day 14. | 1.38 Symptoms | Standard Deviation 1.76 |
| Placebo 1000mg | Mean Number of COVID-19 Symptoms at Day 14. | 1.40 Symptoms | Standard Deviation 1.65 |
p-value: 0.922295% CI: [0.69, 1.4]Mixed Models Analysis
Secondary
Mean Number of COVID-19 Symptoms at Day 3.
Mean number of COVID-19 symptoms (range 0-13) at day 3.
Time frame: Day 3
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hesperidin 1000mg | Mean Number of COVID-19 Symptoms at Day 3. | 4.74 Symptoms | Standard Deviation 2.52 |
| Placebo 1000mg | Mean Number of COVID-19 Symptoms at Day 3. | 4.16 Symptoms | Standard Deviation 2.39 |
p-value: 0.15695% CI: [0.95, 1.37]Mixed Models Analysis
Secondary
Mean Number of COVID-19 Symptoms at Day 7.
Mean number of COVID-19 symptoms (range 0-13) at day 7.
Time frame: Day 7
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hesperidin 1000mg | Mean Number of COVID-19 Symptoms at Day 7. | 3.13 Symptoms | Standard Deviation 2.49 |
| Placebo 1000mg | Mean Number of COVID-19 Symptoms at Day 7. | 2.96 Symptoms | Standard Deviation 2.46 |
p-value: 0.623395% CI: [0.84, 1.33]Mixed Models Analysis
Secondary
Number of Subjects With Complete Disappearance of Any Symptom.
The descriptive statistics are the number of participants having complete disappearance of any symptom.
Time frame: From randomization to occurence of first event, assessed up to 14 days
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With Complete Disappearance of Any Symptom. | Complete disappearance of COVID-19 symptoms after randomization | 29 Participants |
| Hesperidin 1000mg | Number of Subjects With Complete Disappearance of Any Symptom. | No complete disappearance of COVID-19 symptoms after randomization | 77 Participants |
| Placebo 1000mg | Number of Subjects With Complete Disappearance of Any Symptom. | Complete disappearance of COVID-19 symptoms after randomization | 33 Participants |
| Placebo 1000mg | Number of Subjects With Complete Disappearance of Any Symptom. | No complete disappearance of COVID-19 symptoms after randomization | 73 Participants |
p-value: 0.8834Log Rank
Secondary
Number of Subjects With the Cough Symptom.
Number of subjects with the cough symptom at day 10.
Time frame: Day 10
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Cough Symptom. | With Cough Symptom | 26 Participants |
| Hesperidin 1000mg | Number of Subjects With the Cough Symptom. | Without Cough Symptom | 64 Participants |
| Placebo 1000mg | Number of Subjects With the Cough Symptom. | With Cough Symptom | 35 Participants |
| Placebo 1000mg | Number of Subjects With the Cough Symptom. | Without Cough Symptom | 65 Participants |
p-value: 0.371195% CI: [0.41, 1.4]Mixed Models Analysis
Secondary
Number of Subjects With the Cough Symptom.
Number of subjects with the cough symptom at day 3.
Time frame: Day 3
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Cough Symptom. | With Cough Symptom | 54 Participants |
| Hesperidin 1000mg | Number of Subjects With the Cough Symptom. | Without Cough Symptom | 48 Participants |
| Placebo 1000mg | Number of Subjects With the Cough Symptom. | With Cough Symptom | 54 Participants |
| Placebo 1000mg | Number of Subjects With the Cough Symptom. | Without Cough Symptom | 49 Participants |
p-value: 0.941695% CI: [0.59, 1.77]Mixed Models Analysis
Secondary
Number of Subjects With the Cough Symptom.
Number of subjects with the cough symptom at day 7.
Time frame: Day 7
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Cough Symptom. | With Cough Symptom | 37 Participants |
| Hesperidin 1000mg | Number of Subjects With the Cough Symptom. | Without Cough Symptom | 54 Participants |
| Placebo 1000mg | Number of Subjects With the Cough Symptom. | With Cough Symptom | 45 Participants |
| Placebo 1000mg | Number of Subjects With the Cough Symptom. | Without Cough Symptom | 57 Participants |
p-value: 0.629695% CI: [0.49, 1.55]Mixed Models Analysis
Secondary
Number of Subjects With the Cough Symptom.
Number of subjects with the cough symptom at day 14.
Time frame: Day 14
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Cough Symptom. | With Cough Symptom | 21 Participants |
| Hesperidin 1000mg | Number of Subjects With the Cough Symptom. | Without Cough Symptom | 58 Participants |
| Placebo 1000mg | Number of Subjects With the Cough Symptom. | With Cough Symptom | 29 Participants |
| Placebo 1000mg | Number of Subjects With the Cough Symptom. | Without Cough Symptom | 66 Participants |
p-value: 0.569695% CI: [0.42, 1.61]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Anosmia.
Number of subjects with the presence of anosmia at day 10.
Time frame: Day 10
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Anosmia. | With the presence of anosmia | 34 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Anosmia. | Without the presence of anosmia | 56 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Anosmia. | With the presence of anosmia | 37 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Anosmia. | Without the presence of anosmia | 63 Participants |
p-value: 0.912495% CI: [0.57, 1.87]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Anosmia.
Number of subjects with the presence of anosmia at day 3.
Time frame: Day 3
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Anosmia. | With the presence of anosmia | 52 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Anosmia. | Without the presence of anosmia | 50 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Anosmia. | With the presence of anosmia | 59 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Anosmia. | Without the presence of anosmia | 44 Participants |
p-value: 0.368695% CI: [0.45, 1.35]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Anosmia.
Number of subjects with the presence of anosmia at day 7.
Time frame: Day 7
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Anosmia. | With the presence of anosmia | 43 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Anosmia. | Without the presence of anosmia | 48 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Anosmia. | With the presence of anosmia | 47 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Anosmia. | Without the presence of anosmia | 55 Participants |
p-value: 0.871195% CI: [0.59, 1.86]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Anosmia.
Number of subjects with the presence of anosmia at day 14.
Time frame: Day 14
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Anosmia. | With the presence of anosmia | 20 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Anosmia. | Without the presence of anosmia | 59 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Anosmia. | With the presence of anosmia | 31 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Anosmia. | Without the presence of anosmia | 64 Participants |
p-value: 0.295295% CI: [0.36, 1.37]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Diarrhea.
Number of subjects with the presence of diarrhea at day 3.
Time frame: Day 3
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Diarrhea. | With the presence of diarrhea | 22 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Diarrhea. | Without the presence of diarrhea | 80 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Diarrhea. | With the presence of diarrhea | 16 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Diarrhea. | Without the presence of diarrhea | 87 Participants |
p-value: 0.27195% CI: [0.73, 3.06]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Diarrhea.
Number of subjects with the presence of diarrhea at day 14.
Time frame: Day 14
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Diarrhea. | With the presence of diarrhea | 4 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Diarrhea. | Without the presence of diarrhea | 75 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Diarrhea. | With the presence of diarrhea | 4 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Diarrhea. | Without the presence of diarrhea | 91 Participants |
p-value: 0.790695% CI: [0.29, 5.07]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Diarrhea.
Number of subjects with the presence of diarrhea at day 10.
Time frame: Day 10
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Diarrhea. | With the presence of diarrhea | 6 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Diarrhea. | Without the presence of diarrhea | 84 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Diarrhea. | With the presence of diarrhea | 6 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Diarrhea. | Without the presence of diarrhea | 94 Participants |
p-value: 0.851395% CI: [0.34, 3.63]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Diarrhea.
Number of subjects with the presence of diarrhea at day 7.
Time frame: Day 7
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Diarrhea. | With the presence of diarrhea | 15 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Diarrhea. | Without the presence of diarrhea | 76 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Diarrhea. | With the presence of diarrhea | 10 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Diarrhea. | Without the presence of diarrhea | 92 Participants |
p-value: 0.174895% CI: [0.77, 4.3]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Fever.
Number of subjects with the presence of fever (temperature \> 38 degrees) at day 10.
Time frame: Day 10
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Fever. | With the Presence of Fever | 3 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Fever. | Without the Presence of Fever | 87 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Fever. | With the Presence of Fever | 2 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Fever. | Without the Presence of Fever | 97 Participants |
p-value: 0.559195% CI: [0.3, 9.42]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Fever.
Number of subjects with the presence of fever (temperature \> 38 degrees) at day 3.
Time frame: Day 3
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Fever. | With the presence of fever | 5 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Fever. | Without the presence of fever | 96 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Fever. | With the presence of fever | 6 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Fever. | Without the presence of fever | 96 Participants |
p-value: 0.758395% CI: [0.26, 2.67]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Fever.
Number of subjects with the presence of fever (temperature \> 38 degrees) at day 7.
Time frame: Day 7
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Fever. | With the presence of fever | 3 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Fever. | Without the presence of fever | 87 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Fever. | With the presence of fever | 4 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Fever. | Without the presence of fever | 97 Participants |
p-value: 0.809195% CI: [0.2, 3.58]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Fever.
Number of subjects with the presence of fever (temperature \> 38 degrees) at day 14.
Time frame: Day 14
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Fever. | With the presence of fever | 0 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Fever. | Without the presence of fever | 79 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Fever. | With the presence of fever | 1 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Fever. | Without the presence of fever | 93 Participants |
p-value: 0.9983Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Feverish or Chills.
Number of subjects with the presence of feverish or chills at day 10.
Time frame: Day 10
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Feverish or Chills. | With the presence of feverish or chills | 4 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Feverish or Chills. | Without the presence of feverish or chills | 86 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Feverish or Chills. | With the presence of feverish or chills | 6 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Feverish or Chills. | Without the presence of feverish or chills | 94 Participants |
p-value: 0.634895% CI: [0.2, 2.7]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Feverish or Chills.
Number of subjects with the presence of feverish or chills at day 3.
Time frame: Day 3
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Feverish or Chills. | With the presence of feverish or chills | 24 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Feverish or Chills. | Without the presence of feverish or chills | 78 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Feverish or Chills. | With the presence of feverish or chills | 21 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Feverish or Chills. | Without the presence of feverish or chills | 82 Participants |
p-value: 0.589495% CI: [0.62, 2.34]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Feverish or Chills.
Number of subjects with the presence of feverish or chills at day 7.
Time frame: Day 7
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Feverish or Chills. | With the presence of feverish or chills | 10 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Feverish or Chills. | Without the presence of feverish or chills | 81 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Feverish or Chills. | With the presence of feverish or chills | 10 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Feverish or Chills. | Without the presence of feverish or chills | 92 Participants |
p-value: 0.788795% CI: [0.45, 2.89]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Feverish or Chills.
Number of subjects with the presence of feverish or chills at day 14.
Time frame: Day 14
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Feverish or Chills. | With the presence of feverish or chills | 1 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Feverish or Chills. | Without the presence of feverish or chills | 78 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Feverish or Chills. | With the presence of feverish or chills | 3 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Feverish or Chills. | Without the presence of feverish or chills | 92 Participants |
p-value: 0.425795% CI: [0.04, 3.92]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of General Weakness.
Number of subjects with the presence of general weakness at day 7.
Time frame: Day 7
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of General Weakness. | With the presence of general weakness | 39 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of General Weakness. | Without the presence of general weakness | 52 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of General Weakness. | With the presence of general weakness | 40 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of General Weakness. | Without the presence of general weakness | 62 Participants |
p-value: 0.609795% CI: [0.65, 2.07]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of General Weakness.
Number of subjects with the presence of general weakness at day 3.
Time frame: Day 3
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of General Weakness. | With the presence of general weakness | 63 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of General Weakness. | Without the presence of general weakness | 39 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of General Weakness. | With the presence of general weakness | 55 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of General Weakness. | Without the presence of general weakness | 48 Participants |
p-value: 0.229295% CI: [0.8, 2.47]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of General Weakness.
Number of subjects with the presence of general weakness at day 10.
Time frame: Day 10
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of General Weakness. | With the presence of general weakness | 20 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of General Weakness. | Without the presence of general weakness | 70 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of General Weakness. | With the presence of general weakness | 21 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of General Weakness. | Without the presence of general weakness | 79 Participants |
p-value: 0.838995% CI: [0.54, 2.16]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of General Weakness.
Number of subjects with the presence of general weakness at day 14.
Time frame: Day 14
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of General Weakness. | With the presence of general weakness | 14 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of General Weakness. | Without the presence of general weakness | 65 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of General Weakness. | With the presence of general weakness | 17 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of General Weakness. | Without the presence of general weakness | 78 Participants |
p-value: 0.976495% CI: [0.45, 2.17]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Headache.
Number of subjects with the presence of headache at day 10.
Time frame: Day 10
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Headache. | With the presence of headache | 22 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Headache. | Without the presence of headache | 68 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Headache. | With the presence of headache | 20 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Headache. | Without the presence of headache | 80 Participants |
p-value: 0.464395% CI: [0.65, 2.58]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Headache.
Number of subjects with the presence of headache at day 7.
Time frame: Day 7
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Headache. | With the presence of headache | 34 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Headache. | Without the presence of headache | 57 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Headache. | With the presence of headache | 34 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Headache. | Without the presence of headache | 68 Participants |
p-value: 0.561195% CI: [0.66, 2.16]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Headache.
Number of subjects with the presence of headache at day 3.
Time frame: Day 3
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Headache. | With the presence of headache | 48 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Headache. | Without the presence of headache | 54 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Headache. | With the presence of headache | 41 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Headache. | Without the presence of headache | 62 Participants |
p-value: 0.298395% CI: [0.77, 2.35]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Headache.
Number of subjects with the presence of headache at day 14.
Time frame: Day 14
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Headache. | With the presence of headache | 10 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Headache. | Without the presence of headache | 69 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Headache. | With the presence of headache | 9 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Headache. | Without the presence of headache | 86 Participants |
p-value: 0.506395% CI: [0.53, 3.62]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Irritability/Confusion.
Number of subjects with the presence of irritability/confusion at day 3.
Time frame: Day 3
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | With the presence of irritability/confusion | 20 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | Without the presence of irritability/confusion | 82 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | With the presence of irritability/confusion | 18 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | Without the presence of irritability/confusion | 85 Participants |
p-value: 0.696395% CI: [0.57, 2.34]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Irritability/Confusion.
Number of subjects with the presence of irritability/confusion at day 7.
Time frame: Day 7
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | With the presence of irritability/confusion | 6 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | Without the presence of irritability/confusion | 85 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | With the presence of irritability/confusion | 10 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | Without the presence of irritability/confusion | 92 Participants |
p-value: 0.42595% CI: [0.22, 1.88]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Irritability/Confusion.
Number of subjects with the presence of irritability/confusion at day 10.
Time frame: Day 10
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | With the presence of irritability/confusion | 4 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | Without the presence of irritability/confusion | 86 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | With the presence of irritability/confusion | 4 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | Without the presence of irritability/confusion | 96 Participants |
p-value: 0.879795% CI: [0.27, 4.65]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Irritability/Confusion.
Number of subjects with the presence of irritability/confusion at day 14.
Time frame: Day 14
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | With the presence of irritability/confusion | 3 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | Without the presence of irritability/confusion | 76 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | With the presence of irritability/confusion | 1 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Irritability/Confusion. | Without the presence of irritability/confusion | 94 Participants |
p-value: 0.263495% CI: [0.37, 37.03]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Nausea/Vomiting.
Number of subjects with the presence of nausea/vomiting at day 10.
Time frame: Day 10
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | With the presence of nausea/vomiting | 6 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | Without the presence of nausea/vomiting | 84 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | With the presence of nausea/vomiting | 5 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | Without the presence of nausea/vomiting | 95 Participants |
p-value: 0.626595% CI: [0.4, 4.65]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Nausea/Vomiting.
Number of subjects with the presence of nausea/vomiting at day 7.
Time frame: Day 7
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | With the presence of nausea/vomiting | 9 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | Without the presence of nausea/vomiting | 82 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | With the presence of nausea/vomiting | 11 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | Without the presence of nausea/vomiting | 91 Participants |
p-value: 0.839795% CI: [0.36, 2.32]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Nausea/Vomiting.
Number of subjects with the presence of nausea/vomiting at day 3.
Time frame: Day 3
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | With the presence of nausea/vomiting | 21 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | Without the presence of nausea/vomiting | 81 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | With the presence of nausea/vomiting | 12 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | Without the presence of nausea/vomiting | 91 Participants |
p-value: 0.087595% CI: [0.91, 4.27]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Nausea/Vomiting.
Number of subjects with the presence of nausea/vomiting at day 14.
Time frame: Day 14
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | With the presence of nausea/vomiting | 2 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | Without the presence of nausea/vomiting | 77 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | With the presence of nausea/vomiting | 2 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Nausea/Vomiting. | Without the presence of nausea/vomiting | 93 Participants |
p-value: 0.852895% CI: [0.16, 8.91]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Pain.
Number of subjects with the presence of pain at day 3.
Time frame: Day 3
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Pain. | With the presence of pain | 44 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Pain. | Without the presence of pain | 58 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Pain. | With the presence of pain | 50 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Pain. | Without the presence of pain | 53 Participants |
p-value: 0.440395% CI: [0.46, 1.4]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Pain.
Number of subjects with the presence of pain at day 7.
Time frame: Day 7
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Pain. | With the presence of pain | 17 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Pain. | Without the presence of pain | 74 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Pain. | With the presence of pain | 23 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Pain. | Without the presence of pain | 79 Participants |
p-value: 0.511295% CI: [0.39, 1.6]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Pain.
Number of subjects with the presence of pain at day 10.
Time frame: Day 10
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Pain. | With the presence of pain | 13 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Pain. | Without the presence of pain | 77 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Pain. | With the presence of pain | 14 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Pain. | Without the presence of pain | 86 Participants |
p-value: 0.930695% CI: [0.46, 2.36]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Pain.
Number of subjects with the presence of pain at day 14.
Time frame: Day 14
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Pain. | With the presence of pain | 5 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Pain. | Without the presence of pain | 74 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Pain. | With the presence of pain | 8 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Pain. | Without the presence of pain | 87 Participants |
p-value: 0.604695% CI: [0.23, 2.36]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Runny Nose.
Number of subjects with the presence of runny nose at day 14.
Time frame: Day 14
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Runny Nose. | With the presence of runny nose | 12 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Runny Nose. | Without the presence of runny nose | 67 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Runny Nose. | With the presence of runny nose | 10 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Runny Nose. | Without the presence of runny nose | 85 Participants |
p-value: 0.36295% CI: [0.62, 3.76]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Runny Nose.
Number of subjects with the presence of runny nose at day 3.
Time frame: Day 3
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Runny Nose. | With the presence of runny nose | 48 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Runny Nose. | Without the presence of runny nose | 54 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Runny Nose. | With the presence of runny nose | 38 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Runny Nose. | Without the presence of runny nose | 65 Participants |
p-value: 0.143895% CI: [0.87, 2.67]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Runny Nose.
Number of subjects with the presence of runny nose at day 10.
Time frame: Day 10
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Runny Nose. | With the presence of runny nose | 18 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Runny Nose. | Without the presence of runny nose | 72 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Runny Nose. | With the presence of runny nose | 17 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Runny Nose. | Without the presence of runny nose | 83 Participants |
p-value: 0.596895% CI: [0.58, 2.56]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Runny Nose.
Number of subjects with the presence of runny nose at day 7.
Time frame: Day 7
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Runny Nose. | With the presence of runny nose | 25 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Runny Nose. | Without the presence of runny nose | 66 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Runny Nose. | With the presence of runny nose | 22 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Runny Nose. | Without the presence of runny nose | 80 Participants |
p-value: 0.34495% CI: [0.71, 2.68]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Shortness of Breath.
Number of subjects with the presence of shortness of breath at day 7.
Time frame: Day 7
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Shortness of Breath. | With the presence of shortness of breath | 28 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Shortness of Breath. | Without the presence of shortness of breath | 63 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Shortness of Breath. | With the presence of shortness of breath | 30 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Shortness of Breath. | Without the presence of shortness of breath | 72 Participants |
p-value: 0.838295% CI: [0.57, 1.98]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Shortness of Breath.
Number of subjects with the presence of shortness of breath at day 10.
Time frame: Day 10
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Shortness of Breath. | With the presence of shortness of breath | 19 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Shortness of Breath. | Without the presence of shortness of breath | 71 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Shortness of Breath. | With the presence of shortness of breath | 18 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Shortness of Breath. | Without the presence of shortness of breath | 82 Participants |
p-value: 0.591295% CI: [0.59, 2.51]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Shortness of Breath.
Number of subjects with the presence of shortness of breath at day 3.
Time frame: Day 3
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Shortness of Breath. | With the presence of shortness of breath | 46 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Shortness of Breath. | Without the presence of shortness of breath | 56 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Shortness of Breath. | With the presence of shortness of breath | 35 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Shortness of Breath. | Without the presence of shortness of breath | 68 Participants |
p-value: 0.106895% CI: [0.9, 2.82]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Shortness of Breath.
Number of subjects with the presence of shortness of breath at day 14.
Time frame: Day 14
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Shortness of Breath. | With the presence of shortness of breath | 14 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Shortness of Breath. | Without the presence of shortness of breath | 65 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Shortness of Breath. | With the presence of shortness of breath | 13 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Shortness of Breath. | Without the presence of shortness of breath | 82 Participants |
Secondary
Number of Subjects With the Presence of Sore Throat.
Number of subjects with the presence of sore throat at day 10.
Time frame: Day 10
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Sore Throat. | With the presence of sore throat | 6 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Sore Throat. | Without the presence of sore throat | 84 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Sore Throat. | With the presence of sore throat | 8 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Sore Throat. | Without the presence of sore throat | 92 Participants |
p-value: 0.727395% CI: [0.27, 2.49]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Sore Throat.
Number of subjects with the presence of sore throat at day 3.
Time frame: Day 3
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Sore Throat. | With the presence of sore throat | 33 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Sore Throat. | Without the presence of sore throat | 69 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Sore Throat. | With the presence of sore throat | 23 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Sore Throat. | Without the presence of sore throat | 80 Participants |
p-value: 0.111395% CI: [0.89, 3.11]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Sore Throat.
Number of subjects with the presence of sore throat at day 7.
Time frame: Day 7
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Sore Throat. | With the presence of sore throat | 17 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Sore Throat. | Without the presence of sore throat | 74 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Sore Throat. | With the presence of sore throat | 13 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Sore Throat. | Without the presence of sore throat | 89 Participants |
p-value: 0.261395% CI: [0.71, 3.47]Mixed Models Analysis
Secondary
Number of Subjects With the Presence of Sore Throat.
Number of subjects with the presence of sore throat at day 14.
Time frame: Day 14
Population: Number of patients analysed differs from the number of patients assigned to the arm or comparison group as not all subjects replied to the questionnaire or follow-up call, whether a symptom occurred or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hesperidin 1000mg | Number of Subjects With the Presence of Sore Throat. | With the presence of sore throat | 3 Participants |
| Hesperidin 1000mg | Number of Subjects With the Presence of Sore Throat. | Without the presence of sore throat | 76 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Sore Throat. | With the presence of sore throat | 4 Participants |
| Placebo 1000mg | Number of Subjects With the Presence of Sore Throat. | Without the presence of sore throat | 91 Participants |
p-value: 0.890995% CI: [0.19, 4.19]Mixed Models Analysis