Binafuxi granule in the treatment of common cold (heat syndrome): a phase III clinical trial
- Conditions
- Common cold with heat syndrome
- Registration Number
- ITMCTR2100005376
- Lead Sponsor
- West China Hospital, Sichuan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- Not specified
(1) Diagnosis of common cold according to Western medicine and symptom presenting within 48 hours;
(2) With fever and body temperature between 37.5 degree Celsius and 39 degrees Celsius;
(3) Diagnosis of common cold with heat syndrome according to traditional Uighur medicine;
(4) Aged between 18 and 65 years;
(5) Willing to participate and sign the informed consent.
(1) Diagnosis of common cold with cold syndrome according to traditional Uighur medicine;
(2) Patients with influenza, acute or chronic rhinitis, acutel sinusitis, suppurative tonsillitis, pneumonia and Tuberculosis;
(3) white blood cell count>11.0 × 10^9/L and/or neutrophils percentae > 80%;
(4) Patients who are taking any medication to treat common cold;
(5) Patients with gastrointestinal discomfort symptoms such as acute and chronic diarrhea;
(6) Patients with serious primary diseases of the cardiovascular, pulmonary, kidney, liver, neurological and hematological system;
(7) Pregnant women, lactating women, or women who have a birth plan;
(8) Patients with allergic constitution or being allergic to the study drug;
(9) Patients who are participating in or have participated in another drug clinical trial within the last 3 months;
(10) Patients who have been judged by the investigator as inappropriate to participate in the clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The disappearance rate of all symptoms after taking medicine for 3 days;
- Secondary Outcome Measures
Name Time Method Rate of body temperature returned to normal after taking medicine for 1 day, 2 days, 3 days;Time to fever relief;Usage of emergency drug;Time to fever clearance;Traditional Uyghur medicine symptom score;Rate of single symptom disappeared after taking medicine for 1 day, 2 days, 3 days;The duration of all symptoms;