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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
ChiCTR
Registry ID
ChiCTR2100053995
Enrollment
Unknown
Registered
2021-12-06
Start date
2022-07-01
Completion date
Unknown
Last updated
2022-11-07

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

Experiment group:Binafuxi granules
Control group:placebo

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Conform to the diagnosis of common cold in Western medicine, with onset of fever within 48 hours; 2. After this onset, there is obvious fever, and the body temperature of the armpit is 37.5degree<= body temperature<=39.0degree; 3. Uyghur medicine differentiates the syndrome as febrile cold; 4. Aged 18 to 65 years, gender is not limited; 5. Voluntarily participate in this trial and sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Combined with influenza, acute and chronic rhinitis, sinusitis, pneumonia, suppurative tonsillitis, acute tracheo-bronchitis, tuberculosis; 2. Blood WBC>11.0x10^9/L or neutrophil>80%; 3. Those who have received other oral medicines for the disease, such as cold medicine, antiviral medicine, antibiotics, traditional Chinese medicine and other medicines before treatment; 4. Accompanied by symptoms of gastrointestinal discomfort such as acute and chronic diarrhea; 5. Combined with serious primary diseases of the heart, brain, lung, liver, kidney and blood system; 6. Women who are pregnant or planning to become pregnant, lactating women, patients of childbearing age who are unable or unwilling to take adequate contraception during the trial, or their spouses unwilling to take contraceptive measures; 7. Allergic constitution, if there is a history of allergies to two or more drugs or food, or those who are known to be allergic to various components of the research drug; 8. Those who have participated in or are participating in other drug clinical trials within 3 months; 9. According to the judgment of the investigator, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as pregnancy, frequent changes in working environment, unstable living environment, etc., which are likely to cause loss to follow-up.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Public ContactMao Bing

West China Hospital of Sichuan University

maobing@medmail.com.cn+86 18980601724

Outcome results

None listed

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