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A multicenter, randomized, double-blind, positive-controlled clinical trial to evaluate the efficacy and safety of Compound Yinhua Jiedu Granule in the treatment of influenza (wind-heat syndrome)

A multicenter, randomized, double-blind, positive-controlled clinical trial to evaluate the efficacy and safety of Compound Yinhua Jiedu Granule in the treatment of influenza (wind-heat syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027571
Enrollment
Unknown
Registered
2019-11-19
Start date
2019-11-30
Completion date
Unknown
Last updated
2019-11-25

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

Conditions

Tianchang Yifan Pharmaceutical Co. Ltd.

Interventions

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: All the following criteria must be met before the test can be included (1) Meet the clinical diagnosis of influenza; (2) Rapid virus antigen test results of nasopharyngeal swab or oropharyngeal swab were positive; (3) 37.5 degree C <= body temperature (underarm) < 39.5 degree C; (4) Course of disease <= 48 hours (course of disease is defined as the time from onset to this visit, and onset time refers to the time of symptoms and signs of influenza in any of the 9 items including fever, headache, limb pain, chills, fatigue, cough, sore throat, nasal congestion and sweating); (5) TCM syndrome differentiation is wind-heat syndrome; (6) Age: 18 ~ 65 (including 18 and 65 years old), regardless of gender; (7) Participate in the clinical trial voluntarily and sign the written informed consent.

Exclusion criteria

Exclusion criteria: All the following criteria must not be met before the test can be included (1) Clinically diagnosed as severe or critical influenza; (2) The total number of white blood cells was > 10.0 x 10^9/L or the percentage of neutrophils was > 80%. (3) Other types of respiratory infections include acute pharyngitis, tonsillitis, rhinitis, sinusitis, tracheal bronchitis and pneumonia; (4) During the course of this disease, antiviral drugs or Chinese and western drugs for the treatment of influenza have been accepted before randomization; (5) ALT and AST >= 1.5 times the upper limit of normal reference value, and Scr > upper limit of normal reference value; (6) Accompanied by the following serious illness or condition: chronic respiratory diseases, diseases of the cardiovascular system (except for high blood pressure), kidney disease, liver disease, blood system diseases, neurological and neuromuscular disease, metabolic and endocrine system disease, immune function, inhibit (including the application of immunosuppressant or HIV infection to low immune function etc.); (7) BMI greater than 30[BMI= weight (kg)/ height (m)2]; (8) Have a history of allergy to experimental drug ingredients, acetaminophen or drug excipients; (9) Women who are pregnant or nearly 3-month planned pregnancy, lactating women, and women of childbearing age who are unable or unwilling to take adequate contraception during the trial; (10) Mental illness or inability to cooperate with clinical trials; (11) Suspect or have a history of alcohol or drug abuse; (12) Participated in other clinical trials or is participating in other drug clinical trials within the last 3 months; The researchers did not consider it appropriate to participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
Clinical recovery rate;Total clinical efficiency;Individual symptom disappearance rate;Time of symptom disappearance;Deheat effective time;Chinese medicine syndrome effect;

Secondary

MeasureTime frame
Incidence of complication/Severe/Critical;The usage condition of Acetaminophen tablets;

Countries

China

Contacts

Public ContactGaochong zhang
david.zhang@novotekchina.com+86 18911893360

Outcome results

None listed

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