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Open Access 01-12-2015 | Study protocol

Efficacy and safety of Gantong Granules in the treatment of common cold with wind-heat syndrome: study protocol for a randomized controlled trial

Authors: Jie Min, Xiao-qiang Li, Bin She, Yan Chen, Bing Mao

Published in: Trials | Issue 1/2015

Abstract

Background

Although the common cold is generally mild and self-limiting, it is a leading cause of consultations with doctors and missed days from school and work. In light of its favorable effects of relieving symptoms and minimal side-effects, Traditional Chinese Medicine (TCM) has been widely used to treat the common cold. However, there is a lack of robust evidence to support the clinical utility of such a treatment. This study is designed to evaluate the efficacy and safety of Gantong Granules compared with placebo in patients with the common cold with wind-heat syndrome (CCWHS).

Methods/Design

This is a multicenter, phase IIb, double-blind, placebo-controlled and randomized clinical trial. A total of 240 patients will be recruited, from 5 centers across China and randomly assigned to the high-dose group, medium-dose group, low-dose group or placebo control group in a 1:1:1:1 ratio. All subjects will receive the treatment for 3 to 5 days, followed by a 7-day follow-up period. The primary outcome is the duration of all symptoms. Secondary outcomes include the duration of primary symptoms and each symptom, time to fever relief and time to fever clearance, change in TCM symptom score, and change in Symptom and Sign Score.

Discussion

This trial will provide high-quality evidence on the efficacy and safety of Gantong Granules in treating CCWHS, and help to optimize the dose selection for a phase III clinical trial.

Trial registration

The registration number is ChiCTR-TRC-14004255, which was assigned by the Chinese Clinical Trial Registry on 12 February 2014.

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Title: Efficacy and safety of Gantong Granules in the treatment of common cold with wind-heat syndrome: study protocol for a randomized controlled trial
Authors: Jie Min
Xiao-qiang Li
Bin She
Yan Chen
Bing Mao
Publication date: 01-12-2015
Publisher: BioMed Central
Published in: Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-015-0735-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Efficacy and safety of Gantong Granules in the treatment of common cold with wind-heat syndrome: study protocol for a randomized controlled trial

Abstract

Background

Methods/Design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration

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