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01-12-2020 | Bronchial Asthma | Study protocol

Sanfu herbal patch applied at acupoints in patients with bronchial asthma: study protocol for a randomized controlled trial

Authors: Xiaoyan Xie, Danghan Xu, Lixing Zhuang, Hui Liu, Sui Tan, Yanqing Lu, Meiyi Su, Jie Chen, Haihua Pan, Lu Lu, Yiming Xu, Muxi Liao, Zhanqiong Xu, Jun He

Published in: Trials | Issue 1/2020

Abstract

Background

Bronchial asthma is one of the most common inflammatory airway disorders. As one of the main non-drug therapies, the Sanfu herbal patch (SHP) has been widely used to treat bronchial asthma, although the evidence for its efficacy and associated mechanism are inconclusive. The objective of this trial is to clarify the clinical efficacy and safety of the SHP in the treatment of bronchial asthma in the chronic persistent or clinical remission stage and to provide high-quality data for further research.

Methods

We propose a multicentre, double-blinded, parallel, randomized, placebo-controlled clinical trial involving 4 study hospitals in China. A total of 72 eligible participants will be randomized into an SHP group and a placebo group. They will receive an SHP for 3 treatment sessions. The primary outcome will be changes in forced expiratory volume in 1 s after 3 treatment sessions. Secondary outcomes will include the following: (1) the Asthma Quality of Life Questionnaire, Asthma Control Test, and Asthma Long-term Follow-up Scale; (2) levels of Metallothionein-2 and Transgelin-2 in blood and urine; and (3) levels of IL-5, IL-13, IL-23, IL-25, and thymic stromal lymphopoietin in blood. Analysis of the data will be performed at baseline, at the end of the 2nd and 3rd treatment sessions, and at the 24-week follow-up. The safety of the SHP will be evaluated at each treatment session.

Discussion

The aims of this trial are to determine whether the SHP is more effective than placebo in the treatment of patients with bronchial asthma, as well as whether the SHP works by reducing airway inflammation and reversing bronchoconstriction.

Trial registration

Chinese Clinical Trial Registry (http://www.chictr.org.cn), ChiCTR1900024616. Registered on 19 July 2019.

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Title: Sanfu herbal patch applied at acupoints in patients with bronchial asthma: study protocol for a randomized controlled trial
Authors: Xiaoyan Xie
Danghan Xu
Lixing Zhuang
Hui Liu
Sui Tan
Yanqing Lu
Meiyi Su
Jie Chen
Haihua Pan
Lu Lu
Yiming Xu
Muxi Liao
Zhanqiong Xu
Jun He
Publication date: 01-12-2020
Publisher: BioMed Central
Keyword: Bronchial Asthma
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-020-04604-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Sanfu herbal patch applied at acupoints in patients with bronchial asthma: study protocol for a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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