A randomized, double-blind, positive-drug, parallel-controlled multi-center clinical trial of the efficacy and safety of Chaishi Tuire granules for influenza.(RADICAL)

China-Japan Friendship Hospital0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1. Conforms to the western medical diagnosis and treatment standard of influenza (revised version 2018);
•2. Meet the standard of syndrome differentiation of wind-heat syndrome;
•3. Between 18 and 75 years old;
•4. Duration within 48 hours and less, axillary temperature >= 38 degree C;
•5. Rapid virus antigen test results were positive;
•6. Agree and sign informed consent.

•1. Within 12 hours before enrollment, receive relevant drug treatment, such as antibiotics, antiviral drugs, hormone drugs, antipyretic and analgesic drugs, and drugs for treating influenza indicated in the instruction manual;
•2. Complications such as sinusitis, acute bronchitis and pneumonia;
•3. Patients with the following serious lung diseases (such as asthma, chronic bronchitis, tuberculosis, etc.), primary cardiovascular diseases, liver diseases, kidney diseases, hematological diseases, or other serious diseases that affect their survival;
•4. Influenza vaccine was given within 12 months before the trial began;
•5. The upper limit of ALT and AST > normal value is 1.5 times, and the blood Cr exceeds the upper limit of normal value;
•6. Immunodeficiency or immunosuppression, such as AIDS, malignant tumors, organ transplantation, or taking immunosuppressive drugs or glucocorticoids within the last 3 months;
•7. Allergic constitution (allergic to more than 2 kinds of substances), or allergic to the components of this preparation or the control drug;
•8. Pregnant, pregnant or lactating women;
•9. Have participated in other clinical trials within the past month;
•10. Patients who are unable to cooperate or who are mentally ill are considered unfit to participate in this clinical trial.

发起方

China-Japan Friendship Hospital