A multi-center clinical trial to evaluate the efficacy and safety of Kangbingdu Granulesin the treatment of influenza
- Conditions
- influenza
- Registration Number
- ITMCTR1900002747
- 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. Meet diagnostic of influenza inInfluenza.
2. Meet Weiqitongbing-Waiganfenghan Neishangshizhi of traditional Chinese medicine syndrome standard
3. Aged from 14 to 75 years.
4. Course of disease is within 48 hours, axillary temperature >= 37.3 degree C;
5. Tested positive for influenza infection after the onset of symptoms using rapid diagnostic assay, with one or more respiratory symptoms (cough, sore throat or nasal obstruction).
6. Agree and then sign the informed consent.
1. Severe influenza patients;
2. Combined with suppurative tonsillitis, sinusitis, otitis media, acute bronchitis, pneumonia and myocarditis;
3. Combine with serious primary diseases such as heart, brain, liver, kidney and hematopoiesis;
4. Recieved nfluenza vaccine within 12 months ;
5. ALT, AST are greater than the upper limit of normal value 2 times, Scr exceeds the upper limit of normal value;
6. Recieved immunodeficiency, immunosuppression or steroid therapy or other immunosuppressive therapy within 3 months;
7. Allergy to antiviral granules and oseltamivir phosphate or their preparations;
8. Blood cell count > 10 x 10^9 or neutrophil ratio > 80%;
9. Received anti-influenza drug treatment within 24 hours;
10. Pregnancy, pregnancy or lactation women;
11. Suspected or indeed have a history of alcohol or drug abuse;
12. Not suitable for this study judged by investigater.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the time of symtom alleviating;the time of fever relieving;
- Secondary Outcome Measures
Name Time Method TCM symptom score;Dosage of acetaminophen used;incidence of complications (such as Suppurative Tonsillitis, Sinusitis, otitis media, acute bronchitis, Pneumonia and myocarditis etc.);