Binafuxi Granules in the Treatment of Common Cold (Heat Syndrome): a Phase II Clinical Trial

A Randomized, Double-blinded and Placebo-controlled Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Binafuxi Granules in the Treatment of Common Cold (Heat Syndrome)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-17013379

Enrollment

Unknown

Registered

2017-11-14

Start date

2017-12-01

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Common cold

Interventions

Low-dose group:1 bag of Binafuxi granules plus 1 bag of placebo one time, 2 times daily

High-dose group:2 bags of Binafuxi granules one time, 2 times daily

Control group:2 bag of placebo one time, 2 times daily

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of common cold according to Western medicine and symptom presenting within 24 hours; 2. With fever and body temperature between 38.0 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. Patients with influenza, acute or chronic rhinitis, acutel sinusitis, suppurative tonsillitis, pneumonia and Tuberculosis; 2. White blood cell count > 11.0 x 10^9/L and/or neutrophils percentae > 75%; 3. Patients who are taking any medication to treat common cold; 4. liver function levels (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)) 1.5 times higher than the upper limit of normal, abnormal serum creatinine; 5. Patients with serious primary diseases of the cardiovascular, pulmonary, kidney, liver, neurological and hematological system; 6. Pregnant women, lactating women, or women who have a birth plan; 7. Patients with allergic constitution or being allergic to the study drug; 8. Patients who are participating in or have participated in another drug clinical trial within the last 3 months; 9. Patients who have been judged by the investigator as inappropriate to participate in the clinical trial.

Design outcomes

Secondary

Measure	Time frame
Time to fever clearance;The duration of all symptoms;TUM symptom score;	—

Primary

Measure	Time frame
Time to fever relief;	—

Countries

China

Contacts

Public ContactMao Bing

West China Hospital, Sichuan University

maobing@medmail.com.cn+86 18980601724

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 3, 2026