A randomized, double-blind, positive-drug, parallel-controlled multi-center clinical trial of the efficacy and safety of Chaishi Tuire granules for influenza.(RADICAL)
- Conditions
- Influenza
- Registration Number
- ITMCTR1900002740
- Lead Sponsor
- China-Japan Friendship Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method complete antifebrile time;
- Secondary Outcome Measures
Name Time Method Dosage of acetaminophen sustained release agent;TCM symptom score;Remission time for other important clinical symptoms (headache, fatigue, sore throat, coughing, nasal congestion, chills, muscle or joint pain);Antipyretic effect time;AUC disappearance time;