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. 2023 Sep 29;13(9):e070864.
doi: 10.1136/bmjopen-2022-070864.

Shufeng Jiedu capsule for acute exacerbation of chronic obstructive pulmonary disease: a protocol of multicentre, randomised, double-blind, placebo-controlled trial

Ruyu Xia  1 , Yutong Fei  1 , Lishan Zhang  2 , Zhijun Jie  3 , Xiaoyun Fan  4 , Mengyuan Dai  5 , Michael Moore  6 , Merlin Willcox  6 , Xiaoyang Hu  6 , Nick Francis  6 , Changhao Liang  1 , Guanghe Fei #  7 , Jianping Liu #  8
Affiliations

Shufeng Jiedu capsule for acute exacerbation of chronic obstructive pulmonary disease: a protocol of multicentre, randomised, double-blind, placebo-controlled trial

Ruyu Xia et al. BMJ Open. .

Abstract

Introduction: Chronic obstructive pulmonary disease (COPD) represents one of the leading causes of death worldwide. Published clinical trials suggest that the Chinese patent herbal medicine Shufeng Jiedu capsule (SFJD) is safe and may be effective for treating acute exacerbations of COPD (AECOPD). However, these effects have been reported with low or very low certainty evidence. This trial aims to evaluate the effectiveness and safety of SFJD for AECOPD.

Methods and analysis: This study is designed as a multicentre, randomised, double-blind, placebo-controlled trial. Three hundred patients with moderate or severe hospitalised AECOPD will be recruited in Beijing, Shanghai and Hefei. Participants will be randomly assigned to SFJD and usual care or placebo and usual care at a ratio of 1:1. SFJD and placebo will be administered orally four capsules three times daily for 7 consecutive days followed by an 8-week follow-up period. The primary outcome will be COPD symptom severity as measured by the EXAcerbation of Chronic Pulmonary Disease Tool score. Secondary outcomes include clinical symptoms, quality of life, length of hospital stay, a total dose of antibiotics, the frequency of recurrence of AECOPD, haematological biomarkers, death and adverse events. This study will answer the question of whether SFJD was safe to use and will improve symptoms in people with AECOPD, and will therefore reduce the necessity for antibiotics, the risk and duration of admission to hospital, and the risk of recurrence.

Ethics and dissemination: The ethics committee of the first affiliated hospital of Anhui Medical University, Beijing University of Chinese Medicine affiliated Dongzhimen hospital and fifth people's hospital of Shanghai Fudan University approved the study protocol. Informed written consent will be obtained from all the participants. The results of this trial will be disseminated at academic conferences and in peer-reviewed publications.

Trial registration number: ISRCTN99049821.

Keywords: Chronic airways disease; Complementary medicine; Herbal medicine; Randomized Controlled Trial.

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Conflict of interest statement

Competing interests: The authors declare that they have the following possible conflicts of interest. However, these conflicts of interest did not actually influence the design, and the reporting of this study. The Beijing University of Chinese Medicine obtained funding from the Ministry of Science and Technology of the People’s Republic of China for a project investigating the use of Chinese herbal medicine for the treatment of chronic obstructive pulmonary disease. The other partners in the project are the University of Southampton, Anhui Jiren Pharmaceutical Co. (manufacturer of SFJD, providing the trial medication/placebo for free), and Phoenix Medical. The project is part of the “UK-China collaboration to tackle antimicrobial resistance”, funded by the UK and Chinese governments. Ruyu Xia, Yutong Fei, Lishan Zhang, Mengyuan Dai, Guanghe Fei and Jianping Liu received this research funding from Ministry of Science and Technology of the People’s Republic of China; Michael Moore, Merlin Willcox, and Xiaoyang Hu received this research funding from Innovate-UK.

Figures

Figure 1
Figure 1
Study flow chart.
See this image and copyright information in PMC

References

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