ITMCTR1900002747Not yet recruitingPhase 4
A randomized, double-blind, positive-controlled, multicenter study to evaluate the efficacy and safety of Kangbingdu Granulesin the treatment of influenza (Weiqitongbing-Waiganfenghan Neishangshizhi)
China-Japan Friendship Hospital0 sitesStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Ages
- 14 to 75 (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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