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Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Study protocol

Binafuxi granules in the treatment of common cold with heat syndrome based on traditional Uighur medicine: study protocol for a multicenter randomized controlled trial

Authors: Jie Min, Bin She, Xin Zhang, Bing Mao, Yan Chen

Published in: Trials | Issue 1/2019

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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.
Appendix
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Metadata
Title
Binafuxi granules in the treatment of common cold with heat syndrome based on traditional Uighur medicine: study protocol for a multicenter randomized controlled trial
Authors
Jie Min
Bin She
Xin Zhang
Bing Mao
Yan Chen
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3290-y

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