ITMCTR1900002764尚未招募4 期
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)
China-Japan Friendship Hospital0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
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