Binafuxi Granules in the Treatment of Common Cold With Heat Syndrome Based on Traditional Uighur Medicine: Study Protocol for a Multicenter Randomized Controlled Trial

Trials. 2019 Mar 29;20(1):187. doi: 10.1186/s13063-019-3290-y.

Abstract

Background: The common cold is a highly prevalent illness with significant impact on society and health care. Common cold with heat syndrome (CCHS) is one of the most common types based on syndrome differentiation by traditional Uighur medicine (TUM), which is widely used in Central Asia. The study is designed to explore the efficacy, safety and optimal therapeutic dosage of Binafuxi granules in treating CCHS.

Methods: This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. Participants (n = 240) will be enrolled from five centers across China and randomly assigned to the high-dose group, low-dose group or placebo control group in a 1:1:1 ratio. All eligible patients will receive test drugs twice daily for 3 days. The primary outcome is the time to fever relief. Secondary outcomes include the time to fever clearance, duration of primary symptoms and each symptom and change in TUM symptom score.

Discussion: This is the first placebo-controlled randomized clinical trial of a Uighur medicine in treating common cold. It will provide robust evidence on the efficacy and safety of Binafuxi granules in the treatment of CCHS.

Trial registration: Chinese Clinical Trial Registry, ChiCTR-IIR-17013379 . Registered on 14 November 2017.

Keywords: Binafuxi granules; Common cold; Heat syndrome; Randomized controlled trial; Traditional Uighur medicine.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • China
  • Clinical Trials, Phase II as Topic
  • Common Cold / diagnosis
  • Common Cold / drug therapy*
  • Common Cold / physiopathology
  • Common Cold / virology
  • Double-Blind Method
  • Drug Administration Schedule
  • Drugs, Chinese Herbal / administration & dosage
  • Drugs, Chinese Herbal / adverse effects
  • Drugs, Chinese Herbal / therapeutic use*
  • Female
  • Humans
  • Male
  • Medicine, Chinese Traditional / adverse effects
  • Medicine, Chinese Traditional / methods*
  • Middle Aged
  • Multicenter Studies as Topic
  • Randomized Controlled Trials as Topic
  • Time Factors
  • Treatment Outcome
  • Young Adult

Substances

  • Drugs, Chinese Herbal
  • binafuxi