A multi-center, randomized, double-blind, dose-parallel, placebo-controlled phase II clinical trial to evaluate the effectiveness and safety of Ganmao Shuangjie Granules in the treatment of influenza (external cold, internal heat syndrome)
- Conditions
- influenza (external cold, internal heat syndrome
- Registration Number
- ITMCTR2100005067
- Lead Sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
All of the following criteria must be met during screening before being included in the trial
(1) Meet the clinical diagnosis of influenza;
(2) The result of influenza rapid antigen test is positive;
(3) At the time of treatment, body temperature (underarm) 38 to 39.5 degrees C;
(4) Influenza symptoms from the first to the clinic, within 48 hours of the current course;
(5) TCM syndrome differentiation is the outer cold and inner heat syndrome;
(6) Aged from 18 to 65 years old;
(7) Volunteer to participate in this clinical trial and sign a written informed consent.
All of the following criteria must not be met during screening before they can be included in the trial
(1) Clinically diagnosed as severe or critical influenza;
(2) The total number of white blood cells in routine blood examination > 10.0 x 10^9/L, or the percentage of neutrophils > 80%, or symptoms of purulent sputum, suspected of bacterial infection;
(3) Other types of respiratory infections include acute rhinitis, sinusitis, tracheal-bronchitis and pneumonia;
(4) Accompanied by chronic respiratory diseases (such as chronic obstructive pulmonary disease, etc.), cardiovascular diseases (such as coronary heart disease, myocarditis, etc., excluding high blood pressure with stable blood pressure control, asymptomatic old lacunar infarction), nephropathy , Liver disease, blood system disease, nervous system and neuromuscular disease, metabolic and endocrine system disease (such as diabetes), immune function suppression (including the application of immunosuppressive agents or HIV infection caused by immune;
(5) BMI is greater than 30[BMI=weight (kg)/height (m)2];
(6) During the course of this disease, they have received antiviral treatment before randomization;
(7) Have received influenza vaccine in the past year;
(8) Allergic diseases (such as allergic rhinitis, allergic asthma, etc.), or allergies to test drugs, including allergies to the ingredients of this product, acetaminophen or pharmaceutical excipients;
(9) Women who are pregnant or plan to become pregnant within the next 3 months, or breast-feeding women; women of childbearing age who are unable or unwilling to take adequate contraception during the trial period or within one month after the last medication, or their spouses are not willing to take contraceptive measures;
(10) Unable or unwilling to cooperate with clinical trials due to other diseases;
(11) Suspected or true history of alcohol or drug abuse;
(12) Participated in other clinical trials or are participating in clinical trials of other drugs in the past 3 months;
(13) Doctors think it is not suitable to participate in clinical trials.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Curative effect of TCM syndromes;flu symptom score;Comparison of taking acetaminophen tablets;Complications/severe/critically ill incidence;Body temperature (underarm)temperature;
- Secondary Outcome Measures
Name Time Method