common cold
Conditions
Interventions
Test group :Citrus fruit powder eucalyptus oil softgels: 1 capsule once, 3 times a day, before meals
treatment course is 5 days
Control group:Fruit-flavored gummies: 1 capsule once a day, 3 times a day, before meals
the treatment course is 5 days.
Sponsors
Qingdao Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Signed informed consent prior to screening and fully understand the content, process and possible adverse effects of the trial and are able to complete the study in accordance with the requirements of the trial protocol; 2) Male and non-pregnant lactating female subjects aged 18-65 years (including borderline values); 3) Male subjects weighing no less than 50.0 kg and female subjects weighing no less than 45.0 kg with a body mass index (BMI) within the range of 19.0-26.0 [BMI = weight (kg)/height2(m2)] (including borderline values); 4) Meet clinical diagnostic criteria for the common cold; 5) have a time interval of =48 h from the onset of disease symptoms prior to screening (definition of the onset of disease symptoms: the time of the first increase in body temperature (axillary temperature =37.4°C) or the time of the onset of at least one systemic or respiratory symptom associated with the common cold). 6) If the subject is taking antipyretic and anti-inflammatory medication prior to enrollment, the informed consent must be signed at least 4h after taking the medication; 7) Subjects (including male subjects) are willing to be childless and voluntarily use contraception and do not plan to donate sperm or eggs from screening until 1 month after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1) History of chronic or serious illnesses such as neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, hematologic and lymphatic, hepatic and renal function, endocrine, or immune system disorders, or any other illnesses that may affect the results of the study; 2) Fever caused by reasons other than this disease (e.g. influenza, drug reaction, tumor, etc.) or fever of unknown origin; 3) patients with thick purulent nasal discharge and sputum, increased pain in the paranasal sinuses (usually unilateral) and pharynx, shortness of breath, hemoptysis, suspected pneumonia, heart failure, immunodeficiency, and inhalation toxicity 4) Patients with a positive rapid influenza antigen test on a pharyngeal swab or nasal swab; 5) those with a leukocyte count >10.0×109/L and/or neutrophil percentage >85% on routine blood test; 6) those who have a positive blood pregnancy test (for females); 7) those with a confirmed diagnosis of a bacterial or viral infection requiring systemic antimicrobial or antiviral therapy at Screening; and those with severe symptoms requiring antipyretic and analgesic medications as evaluated by the Investigator at Screening; 8) persons with a history of substance abuse within 6 months prior to screening or who have used drugs within 3 months prior to screening 9) those who have difficulty swallowing, a history of esophageal disease or a history of gastrointestinal surgery; 10) have taken or consumed certain fruit juices (grapefruit juice, grapefruit juice, etc.) or cocoa, chocolate, etc. that may affect metabolism within 48h prior to using the product; 11) Those who have a symptom score of less than 4; 12) patients who have participated in a clinical trial of another drug within 1 month or are participating in a clinical trial; 13) Those who, in the opinion of the investigator, are not suitable for participation in a clinical trial or are otherwise unable to complete this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of improvement in each clinical sign and symptom (nasal congestion, runny nose, sneezing, coughing, sore throat, pharyngeal redness, hoarseness, headache, generalized body aches) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood routine examination;CRP;cytokines(IL-6,8,10, TNF-a); | — |
Countries
China
Contacts
Public ContactZhou xuefeng
Qingdao Central Hospital
Outcome results
None listed