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A multi-center clinical trial to evaluate the efficacy and safety of Kangbingdu Granulesin the treatment of influenza

A randomized, double-blind, positive-controlled, multicenter study to evaluate the efficacy and safety of Kangbingdu Granulesin the treatment of influenza (Weiqitongbing-Waiganfenghan Neishangshizhi)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027409
Enrollment
Unknown
Registered
2019-11-12
Start date
2019-11-20
Completion date
Unknown
Last updated
2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

influenza

Interventions

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
the time of symtom alleviating;the time of fever relieving;

Secondary

MeasureTime frame
Dosage of acetaminophen used;TCM symptom score;incidence of complications (such as Suppurative Tonsillitis, Sinusitis, otitis media, acute bronchitis, Pneumonia and myocarditis etc.);

Countries

china

Contacts

Public ContactJiangtao Lin

China-Japan Friendship Hospital

jingtao_l@263.net+86 13501158163

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026