Shufeng Jiedu capsule for acute exacerbation of chronic obstructive pulmonary disease: a protocol of multicentre, randomised, double-blind, placebo-controlled trial
Shufeng Jiedu capsule for acute exacerbation of chronic obstructive pulmonary disease: a protocol of multicentre, randomised, double-blind, placebo-controlled trial
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.
Chronic airways disease, Complementary medicine, Herbal medicine, Randomized Controlled Trial
Xia, Ruyu
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Fei, Yutong
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Zhang, Lishan
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Jie, Zhijun
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Fan, Xiaoyun
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Dai, Mengyuan
cb5f29d2-d64e-452b-b4ae-a21a654ce64b
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Willcox, Merlin
dad5b622-9ac2-417d-9b2e-aad41b64ffea
Hu, Xiaoyang
65904b24-3775-4b14-9532-eb703a056655
Francis, Nick
9b610883-605c-4fee-871d-defaa86ccf8e
Liang, Changhao
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Fei, Guanghe
3b18e1f3-9473-4deb-b620-371c0d8dce86
Liu, Jianping
37712d9a-587a-48e0-a92d-084dced87ab0
Xia, Ruyu
394737f7-9ef2-4036-970e-a47eb559b737
Fei, Yutong
38d05d9e-30d7-48b4-b86d-768abefede0c
Zhang, Lishan
49832982-cf3d-4531-8342-0c648b41e6c9
Jie, Zhijun
16e20840-aa99-4a9c-a1bc-57266bfaff82
Fan, Xiaoyun
35847f27-b72c-4455-9941-a071ca1b791f
Dai, Mengyuan
cb5f29d2-d64e-452b-b4ae-a21a654ce64b
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Willcox, Merlin
dad5b622-9ac2-417d-9b2e-aad41b64ffea
Hu, Xiaoyang
65904b24-3775-4b14-9532-eb703a056655
Francis, Nick
9b610883-605c-4fee-871d-defaa86ccf8e
Liang, Changhao
26ca5d35-510a-4d9e-b634-22c8723dc6a2
Fei, Guanghe
3b18e1f3-9473-4deb-b620-371c0d8dce86
Liu, Jianping
37712d9a-587a-48e0-a92d-084dced87ab0
Xia, Ruyu, Fei, Yutong, Zhang, Lishan, Jie, Zhijun, Fan, Xiaoyun, Dai, Mengyuan, Moore, Michael, Willcox, Merlin, Hu, Xiaoyang, Francis, Nick, Liang, Changhao, Fei, Guanghe and Liu, Jianping
(2023)
Shufeng Jiedu capsule for acute exacerbation of chronic obstructive pulmonary disease: a protocol of multicentre, randomised, double-blind, placebo-controlled trial.
BMJ Open, 13 (9), [e070864].
(doi:10.1136/bmjopen-2022-070864).
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.
Text
e070864.full
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More information
Accepted/In Press date: 20 August 2023
e-pub ahead of print date: 29 September 2023
Additional Information:
Funding Information:
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.
Funding Information:
This work was supported by the National Key Research and Development Project (grant no. 2018YFE0102300). The funding sources had no role in the design, decision to publish or preparation of the manuscript.
Keywords:
Chronic airways disease, Complementary medicine, Herbal medicine, Randomized Controlled Trial
Identifiers
Local EPrints ID: 483463
URI: http://eprints.soton.ac.uk/id/eprint/483463
ISSN: 2044-6055
PURE UUID: 540a9329-d636-4a7d-aab4-413664c4c310
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Date deposited: 31 Oct 2023 17:43
Last modified: 18 Mar 2024 03:54
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Contributors
Author:
Ruyu Xia
Author:
Yutong Fei
Author:
Lishan Zhang
Author:
Zhijun Jie
Author:
Xiaoyun Fan
Author:
Mengyuan Dai
Author:
Changhao Liang
Author:
Guanghe Fei
Author:
Jianping Liu
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