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. 2019 Jan 3;20(1):3.
doi: 10.1186/s13063-018-3073-x.

Chinese herbal medicine for the treatment of cough variant asthma: a study protocol for a double-blind randomized controlled trial

Rong-Rong Fan  1 , Ze-Huai Wen  2   3 , Da-Wei Wang  2   4 , Rong-Yuan Yang  2   4 , Ai-Hua Ou  2 , Lian-Shun Jin  2   4 , Zhong-de Zhang  5   6 , Yun-Tao Liu  7
Affiliations

Chinese herbal medicine for the treatment of cough variant asthma: a study protocol for a double-blind randomized controlled trial

Rong-Rong Fan et al. Trials. .

Abstract

Background: Cough variant asthma (CVA) is one of the leading causes of chronic coughing. The main treatment is currently anti-inflammatory medication. However, the coughing may return or be aggravated and lung function may deteriorate once the anti-inflammatory treatment is stopped. The effect of Chinese herbal medicine (CHM) on chronic coughing is remarkable, but high-quality evidence supporting its effectiveness is still lacking. This trial aims to evaluate the safety and efficacy, especially the long-term efficacy, of CHM plus anti-inflammatory medications for the treatment of CVA.

Methods/design: A randomized placebo-controlled double-blind trial will be conducted. It will consist of a 3-month intervention followed by a 6-month follow-up period. The target sample size is 60 patients with CVA who are between 18 and 70 years old. The eligible subjects will be allocated randomly into the experimental or control group in a ratio of 1:1. Patients in the experimental group will take CHM granules (4.9 g twice daily), while patients in the control group will be given a matched placebo. An administration of salmeterol/fluticasone propionate combination for 12 weeks will be the basic therapy for the two groups. The primary outcome is the cough visual analog scales (CVAS). The secondary outcomes include quality of life, rate of symptom relapse, lung function, and blood tests. A safety assessment will also be performed during the trial.

Discussion: The evidence gathered by the trial will be a valuable addition to informing treatment options for patients with CVA.

Trial registration: http://www.chictr.org.cn , ID: ChiCTR-IOR-16009148. Registered on 3 September 2016.

Keywords: Chinese herbal medicine; Cough variant asthma; Randomized controlled trial.

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Conflict of interest statement

Ethics approval and consent to participate

The trial has been approved by the Institutional Ethics Committee of GPHCM (B2016–097-01). Any protocol amendments must be reported to the Department of Science Research of GPHCM and agreed by the ethics committee. Each participant will receive information on this research, including the potential benefits and risks. The investigators must obtain informed consent from a patient before they are randomized. The personal information of the enrolled participants will be kept confidential. Only relevant investigators can access this information.

Consent for publication

Only anonymized data obtained in the observational study will be reported. Informed consent has been obtained from the patients for publication.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

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Fig. 2
Trial flow chart. CHM Chinese herbal medicine, SFC salmeterol/fluticasone propionate combination
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