Respiratory Inflammation
Conditions
Keywords
Essential Oil, Dietary Supplement, Low Tract Respiratory Infection, Symptom Management, Respiratory Complaints, Emergency Department
Brief summary
The goal of this clinical trial is to explore the impact of a dietary supplement containing essential oils on symptom severity in patients presenting to the ED with respiratory complaints. It will also learn about the safety of this diet supplement. The main question it aims to answer is : • Does Ubiotique lower the severity of symptoms (cough, sputum, fatigue) in patients presenting to the emergency department with respiratory complaints. Researchers will compare drug Ubiotique to a placebo (a look-alike substance that contains no drug) to see if drug Ubiotique works to reduce symptoms (Cough, sputum, fatigue). Participants will: * Take Ubiotique or a placebo three times per day for ten days * Be phone-called to be followed-up at day 3, 5, and 7post emergency visit * Keep a diary of their symptoms and give a score to the severity of each symptom
Detailed description
Patients treated with Essential oil treatment and placebo received 1 capsule 3 times per day. At the end of management at the ED, the investigator gave the caps box to the patient and explained the follow-up process. The investigator phoned the patients on days 1, 3, 5, 7, and 10 of the ED visits to complete their follow-up. No other changes in the management were indicated. No extra tests were required for the trial. All the clinical, radiological, and biological data were recorded. There were no further changes in the prescribed treatments at discharge. Outcomes measures: The primary study endpoint was the benefits of Essential Oil in reducing symptoms' severity (cough, sputum, fatigue). The severity of these symptoms was self-reported by the patient on a 5-point Likert scale (0 = not present, 1 = somewhat present, 2 = present, 3 = present and challenging, 4= Always present and highly challenging). The difference in symptom severity between Day 3, Day 5, Day 7, and the baseline severity of the three main symptoms (Cough, sputum, fatigue) was calculated for each patient. The value was negative if there was a decrease in the symptom severity and positive when the symptom severity increased. These values were compared in the two groups of patients to assess the decrease in symptoms' severity. The secondary endpoints included safety and adherence to the treatment, and the presence of adverse events. Serious adverse events or reactions (death, life-threatening condition during the study period, unplanned hospitalization, unplanned prolongation of the current hospitalization, persistent disability) were recorded during the follow-up of all the patients. Unfavorable symptoms were also evaluated; the participants were asked if they experienced any changes or symptoms (smell, gastrointestinal symptoms, transit abnormality, urinary tract symptoms). If yes, they were asked to rate the symptom from 0 to 3.
Interventions
DIETARY_SUPPLEMENTessential oils of eucalyptus, thyme, cinnamon, lavender, winter savory, tea tree, camphor tree
The essential oil capsule used in this study is a commercially available product that can be purchased without a prescription; however, it is not included in conventional or academic treatment protocols for lower respiratory infections and was evaluated in this trial solely for research purposes. Participants randomized to the intervention group received an oral capsule containing a combination of botanical essential oils, including eucalyptus (20 mg), thyme (20 mg), cinnamon (10 mg), lavender (20 mg), winter savory (20 mg), tea tree (20 mg), and camphor tree (20 mg). Participants in the control group received a placebo capsule identical in appearance, taste, smell, consistency, and packaging. Study medication was administered at a dose of one capsule three times daily for a total duration of 10 days. The study capsules were provided by the investigator at the time of emergency department discharge, and participants received standardized instructions regarding treatment administration.
DIETARY_SUPPLEMENTplacebo of the essential oil capsule
the placebo capsule were identical in color, taste, smell, consistency, and packaging and do not contains essential oils.
Sponsors
University of Sfax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive patients presenting with acute cough and at least one of the following symptoms: sputum production, dyspnea, wheezing, or chest discomfort/pain * No alternative explanation for symptoms
Exclusion criteria
* Non-communicating patients * Pregnant patients * Patients with known allergy to study components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary study endpoint was the benefits of Essential Oil in reducing symptoms (cough, sputum, fatigue). | The investigator phoned the patients on days 1, 3, 5, 7, and 10 of the ED visits to complete their follow-up. No other changes in the management were indicated. | The severity of these symptoms was self-reported by the patient on a 5-point Likert scale (0 = not present, 1 = somewhat present, 2 = present, 3 = present and challenging, 4= Always present and highly challenging). As these symptoms are clinically linked, we calculated the total symptom severity score. The sum of the cough, sputum, and fatigue scores was defined as the composite symptoms score. Based on the calculated score, the severity of the symptoms was considered minor (score under 4), moderate (score between 4 and 8), or severe (score 9 or more). For each patient, the difference in symptoms score was calculated between Day 3, Day 5, Day 7, and the baseline severity. The value is negative when symptom severity decreases, and positive when symptom severity increases. The percentage of symptoms remaining at Day 3 was calculated for each participant as the ratio of the Day 3 symptom score to the baseline score, multiplied by 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| secondary outcomes: • the change of each symptom (cough, sputum, fatigue), • Safety and tolerability of the intervention • Adherence to treatment • Incidence of adverse events | The followup is conducted on Day 3, Day 5, Day 7, by phone call. | The secondary endpoints were the change of each symptom (cough, sputum, fatigue), safety and adherence to the treatment, and the presence of adverse events. We calculated the difference of each symptom score (cough, sputum, fatigue) between Day 3, Day 5, Day 7, and the baseline for each patient. We recorded serious adverse events or reactions (death, life-threatening conditions during the study period, unplanned hospitalizations, unplanned prolongation of current hospitalizations, persistent disabilities) during the follow-up of all patients. We also assessed unfavourable symptoms; participants were asked whether they experienced any changes or symptoms (smell, gastrointestinal symptoms, transit disturbances, or urinary tract symptoms). If yes, they were asked to rate the symptom from 0 to 3. Approval from the ethics committee was obtained. |
Countries
Tunisia
Contacts
STUDY_CHAIRnoureddine rekik, professor, head of the departm
habib bourguiba university hospial, faculty of medicine sfax university
Outcome results
None listed