A multicenter, randomized, double-blind, positive-controlled clinical trial to evaluate the efficacy and safety of Compound Yinhua Jiedu Granule in the treatment of influenza (wind-heat syndrome)
- Conditions
- Tianchang Yifan Pharmaceutical Co. Ltd.
- Registration Number
- ITMCTR1900002764
- Lead Sponsor
- China-Japan Friendship Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
All the following criteria must be met before the test can be included
(1) Meet the clinical diagnosis of influenza;
(2) Rapid virus antigen test results of nasopharyngeal swab or oropharyngeal swab were positive;
(3) 37.5 degree C <= body temperature (underarm) < 39.5 degree C;
(4) Course of disease <= 48 hours (course of disease is defined as the time from onset to this visit, and onset time refers to the time of symptoms and signs of influenza in any of the 9 items including fever, headache, limb pain, chills, fatigue, cough, sore throat, nasal congestion and sweating);
(5) TCM syndrome differentiation is wind-heat syndrome;
(6) Age: 18 ~ 65 (including 18 and 65 years old), regardless of gender;
(7) Participate in the clinical trial voluntarily and sign the written informed consent.
All the following criteria must not be met before the test can be included
(1) Clinically diagnosed as severe or critical influenza;
(2) The total number of white blood cells was > 10.0 x 10^9/L or the percentage of neutrophils was > 80%.
(3) Other types of respiratory infections include acute pharyngitis, tonsillitis, rhinitis, sinusitis, tracheal bronchitis and pneumonia;
(4) During the course of this disease, antiviral drugs or Chinese and western drugs for the treatment of influenza have been accepted before randomization;
(5) ALT and AST >= 1.5 times the upper limit of normal reference value, and Scr > upper limit of normal reference value;
(6) Accompanied by the following serious illness or condition: chronic respiratory diseases, diseases of the cardiovascular system (except for high blood pressure), kidney disease, liver disease, blood system diseases, neurological and neuromuscular disease, metabolic and endocrine system disease, immune function, inhibit (including the application of immunosuppressant or HIV infection to low immune function etc.);
(7) BMI greater than 30[BMI= weight (kg)/ height (m)2];
(8) Have a history of allergy to experimental drug ingredients, acetaminophen or drug excipients;
(9) Women who are pregnant or nearly 3-month planned pregnancy, lactating women, and women of childbearing age who are unable or unwilling to take adequate contraception during the trial;
(10) Mental illness or inability to cooperate with clinical trials;
(11) Suspect or have a history of alcohol or drug abuse;
(12) Participated in other clinical trials or is participating in other drug clinical trials within the last 3 months;
The researchers did not consider it appropriate to participate in clinical trials.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Chinese medicine syndrome effect;Individual symptom disappearance rate;Clinical recovery rate;Deheat effective time;Time of symptom disappearance;Total clinical efficiency;
- Secondary Outcome Measures
Name Time Method Incidence of complication/Severe/Critical;The usage condition of Acetaminophen tablets;