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Efficacy and safety of Chaiyin granules for the treatment of influenza (exogenous wind-heat syndrome): a randomized, double-blind, positive drug control, multicenter clinical trial

Efficacy and safety of Chaiyin granules for the treatment of influenza(exogenous wind-heat syndrome): a randomized, double-blind, positive drug control, multicenter clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045288
Enrollment
Unknown
Registered
2021-04-10
Start date
2021-04-13
Completion date
Unknown
Last updated
2021-11-16

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
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-65 years old, no gender limit; 2.Meet the diagnostic criteria of Western medicine for influenza; 3.Those whose rapid influenza antigen test results are positive; 4.Comply with the dialectical standard of TCM syndrome of exogenous wind-heat; 5.Those with axillary temperature >= 38 ?; 6.Within 48 hours of onset (definition of onset time: fever accompanied by other typical flu symptoms such as headache, myalgia, chills, chills, muscle and joint aches, fatigue, sore throat, dry cough, nasal congestion, runny nose, etc., at least 1 item); 7.Sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions.

Exclusion criteria

Exclusion criteria: 1.People with allergies or allergies to known ingredients of test drugs or control drugs; 2.Those who meet the diagnostic criteria for severe and critical cases in the "Influenza Diagnosis and Treatment Plan (2020 Edition)" issued by the Ministry of Health; 3.There are other serious clinical conditions that require monitoring and treatment; 4.Acute bacterial sinusitis, allergic rhinitis, tracheitis-bronchitis, pneumonia, herpetic angina and other diseases; 5.Patients with severe primary diseases of cardiovascular, cerebrovascular, lung, kidney and hematopoietic system; 6.Patients with acute or chronic gastroenteritis and unexplained diarrhea within 1 week before administration; 7.Liver function test values ?(ALT, AST) exceed 1.5 times the upper limit of normal; blood creatinine exceeds the upper limit of normal; 8.White blood cells 10.0 x 109/L; and/or total number of neutrophils> the upper limit of normal value, consider those with bacterial infection; 9.Those who use other drugs for the treatment of this disease (including antiviral, hormone and other Chinese and Western drugs and treatment methods) within 24 hours before administration; 10.Suspected or did have a history of alcohol or drug abuse; 11.Women who are pregnant or preparing to become pregnant, breast-feeding women, persons of childbearing age who are unable or unwilling to take adequate contraception during the trial, or whose spouse is unwilling to take contraceptive measures; 12.Those who cannot cooperate with mental disorders; 13.Those who have participated in other interventional clinical trials within the past 3 months; 14.The investigator believes that it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Time to remission of clinical symptoms of influenza;

Secondary

MeasureTime frame
Disease recovery time/recovery rate;Antifebrile effect time/Completely antifebrile time;TCM syndrome efficacy;Negative rate of virus;Complication,severe illness,critical illness incidence;The frequency and the dosage of emergency medicine;

Countries

China

Contacts

Public ContactZhang Baigang

China-Japan Friendship Hospital

zhangbogang@clkc.cn+86 13651385394

Outcome results

None listed

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