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Binafuxi granule in the treatment of common cold (heat syndrome): a phase III clinical trial

Efficacy and safety of Binafuxi granule in the treatment of common cold (heat syndrome): a multi-center, randomized, double-blind, placebo-controlled phase III clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005376
Enrollment
Unknown
Registered
2021-03-27
Start date
2022-07-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Common cold with heat syndrome

Interventions

Control group:1 bag of placebo granules per time, twice daily
Experiment group:1 bag of Binafuxi granules per time, twice daily

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Diagnosis of common cold according to Western medicine and symptom presenting within 48 hours; (2) With fever and body temperature between 37.5 degree Celsius and 39 degrees Celsius; (3) Diagnosis of common cold with heat syndrome according to traditional Uighur medicine; (4) Aged between 18 and 65 years; (5) Willing to participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Diagnosis of common cold with cold syndrome according to traditional Uighur medicine; (2) Patients with influenza, acute or chronic rhinitis, acutel sinusitis, suppurative tonsillitis, pneumonia and Tuberculosis; (3) white blood cell count>11.0 × 10^9/L and/or neutrophils percentae > 80%; (4) Patients who are taking any medication to treat common cold; (5) Patients with gastrointestinal discomfort symptoms such as acute and chronic diarrhea; (6) Patients with serious primary diseases of the cardiovascular, pulmonary, kidney, liver, neurological and hematological system; (7) Pregnant women, lactating women, or women who have a birth plan; (8) Patients with allergic constitution or being allergic to the study drug; (9) Patients who are participating in or have participated in another drug clinical trial within the last 3 months; (10) Patients who have been judged by the investigator as inappropriate to participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
The disappearance rate of all symptoms after taking medicine for 3 days;

Secondary

MeasureTime frame
Rate of body temperature returned to normal after taking medicine for 1 day, 2 days, 3 days;Time to fever relief;Usage of emergency drug;Time to fever clearance;Traditional Uyghur medicine symptom score;Rate of single symptom disappeared after taking medicine for 1 day, 2 days, 3 days;The duration of all symptoms;

Countries

China

Contacts

Public ContactMao Bing
maobing@medmail.com.cn18980601724

Outcome results

None listed

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