Bing Mao	

Jie Min

Bin She

Xin Zhang

Yan Chen

https://doi.org/10.1186/s13063-019-3290-y

Figure 1

Figure 2

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

CC BY 4.0

Background

Common cold is a highly prevalent illness with significant impact on society and health care. Common cold with heat syndrome (CCHS) is one of most common type based on traditional Uighur medicine (TUM) syndrome differentiation, which is widely used in Central Asia. This 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. A total of 240 patients will be recruited from 5 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 subjects 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, change in TUM symptom score.

Discussion

This is the first placebo-controlled randomized clinical trial for 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

The registration number is ChiCTR-IIR-17013379, which was assigned by the Chinese Clinical Trial Registry on 14 November 2017.

Form responses:
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* Level of interest: **An article whose findings are important to those with closely related research interests**
* Quality of written English: **Acceptable**
* Quality of figures: **Acceptable**
* Statistical review: **Yes, and I have assessed the statistics in my report**
* Declaration of competing interests: **I declare that I have no competing interests**

Comments to Author:
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The authors have attended and response all my comments. There is only one minor question. 
The SPIRIT is a guidance for reporting a study protocol, not for study procedure. You might describe that "The study protocol comply with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)" (Page 9). The author used ANOVA method to estimate sample size with the primary outcome time to fever relief (Page 15) and Kaplan-Meier method was described in statistical analysis (Page 16). Please explain the reason.

Form responses:
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* Level of interest: **An article of importance in its field**
* Quality of written English: **Acceptable**
* Quality of figures: **Acceptable**
* Statistical review: **Yes, but I do not feel adequately qualified to assess the statistics**
* Declaration of competing interests: **I declare that I have no competing interests**

Comments to Author:
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(no comments provided)

Form responses:
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* Level of interest: **An article of importance in its field**
* Quality of written English: **Needs some language corrections before being published**
* Quality of figures: **Acceptable**
* Statistical review: **Yes, and I have assessed the statistics in my report**
* Declaration of competing interests: **I declare that I have no competing interests**

Comments to Author:
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The manuscript reported a planned randomized trial that wanted to assess Binafuxi Granules for common cold with heat syndrome. It sounded complying with the SPIRIT 2013 statement. My main concerns are below.
1.The study was intended to be a three-arm dose-response trial. Is it necessary to consider a superiority trial that will establish a hypothesis of superiority to placebo with an appropriate superiority margin? The sample size calculation can not be repeated because there are no corresponding parameters available.
2.In randomization process, was stratified by center or other factor?
3.Considering the process of double-blind, Batch No. Y170521 for Binafuxi Granules Batch No. Y170520 for placebo should be confidential to participants, investigators and statistician et al. Additionally, it is suggested that the trial should be established a procedure to deal with accidental unblinding due to a serious adverse event or emergency event.
4.In regards to statistical analyses, intention-to-treat analysis principle is suggested to be performed in the trial. Aproach for dealing with missing data should be mentioned too. If the ANCOVA method is used, it is recommended that co-variables would be indicated in advance. Some pre-planned subgroup analysis and sensitivity analysis would be further identified.

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

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Abstract

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Supplementary Files

Status:

Journal Publication

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