ITMCTR2100004720尚未招募4 期
Efficacy and safety of Chai Yin granules for the treatment of influenza(exogenous wind-heat syndrome): a randomized, double-blind, positive drug control, multicenter clinical trial
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
- •(1)Aged 18 to 65 years old,no gender limitation;
- •(2)Consistent with the clinical diagnosis of influenza;
- •(3)Patients whose rapid influenza diagnostic tests result are positive;
- •(4)Patients who accord with the dialectical standard of exogenous wind-heat syndrome in traditional Chinese medicine;
- •(5)The axillary temperature 38 ? or higher;
- •(6)Course within 48 hours(Definition of onset time of disease:fever with other typical flu symptoms,for instance headache,myalgia,chilly,shiver,joint pain,weak,pharyngalgia,cough,nasal congestion,runny nose,etc.at least one of the above);
- •(7)Sign the informed consent before the test,and have a good understanding of the test contents, process and possible adverse reactions.
排除标准
- •(1)Allergic constitution or allergic to known components of the test drug or control drug;
- •(2)Patients who accord with the diagnostic criteria of Severe and critically ill cases in Influenza Diagnosis and Treatment Protocol (2020 Edition) published by National Health Commission;
- •(3)The occurrence of other serious clinical conditions requiring monitoring treatment;
- •(4)Patients with acute bacterial sinusitis,anaphylactic rhinitis,tracheitis - bronchitis,pneumonia,herpangina,etc.;
- •(5)Patients with serious primary diseases of cardiovascular,cerebrovascular,lung,kidney and hematopoietic system;
- •(6)Patients with acute or chronic gastroenteritis and unexplained diarrhea 1 week before administration;
- •(7)Liver function test values (ALT, AST) were 1.5 times higher than the upper limit of normal values;Serum creatinine exceeds the upper limit of normal;
- •(8)Blood leukocyte <3.0×10^9/L or >10.0×10^9/L;and/or neutrophils above the upper limit of normal values,consider bacterial infection;
- •(9)Patients who have taken other medications for the disease within 24 hours prior to administration(Including antiviral, hormone and other Chinese and western drugs and treatment methods);
- •(10)Suspected or present history of alcohol or drug abuse;
- •(11)Pregnancy,preparing for pregnancy or lactating women,patients who are in reproductive age unable or unwilling take adequate contraceptive measures or their spouse's reluctance to use contraception;
- •(12)Patients with mental disorders who are unable to cooperate;
- •(13)Participated in other interventional clinical trials within the last 3 months;
- •(14)Patients deemed unsuitable by the investigator to participate in this clinical trial.
研究者
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