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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). H...

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Autores principales: Xia, Ruyu, Fei, Yutong, Zhang, Lishan, Jie, Zhijun, Fan, Xiaoyun, Dai, Mengyuan, Moore, Michael, Willcox, Merlin, Hu, Xiaoyang, Francis, Nick, Liang, Changhao, Fei, Guanghe, Liu, Jianping
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10546128/
https://www.ncbi.nlm.nih.gov/pubmed/37775286
http://dx.doi.org/10.1136/bmjopen-2022-070864
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author Xia, Ruyu
Fei, Yutong
Zhang, Lishan
Jie, Zhijun
Fan, Xiaoyun
Dai, Mengyuan
Moore, Michael
Willcox, Merlin
Hu, Xiaoyang
Francis, Nick
Liang, Changhao
Fei, Guanghe
Liu, Jianping
author_facet Xia, Ruyu
Fei, Yutong
Zhang, Lishan
Jie, Zhijun
Fan, Xiaoyun
Dai, Mengyuan
Moore, Michael
Willcox, Merlin
Hu, Xiaoyang
Francis, Nick
Liang, Changhao
Fei, Guanghe
Liu, Jianping
author_sort Xia, Ruyu
collection PubMed
description 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.
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spelling pubmed-105461282023-10-04 Shufeng Jiedu capsule for acute exacerbation of chronic obstructive pulmonary disease: a protocol of multicentre, randomised, double-blind, placebo-controlled trial Xia, Ruyu Fei, Yutong Zhang, Lishan Jie, Zhijun Fan, Xiaoyun Dai, Mengyuan Moore, Michael Willcox, Merlin Hu, Xiaoyang Francis, Nick Liang, Changhao Fei, Guanghe Liu, Jianping BMJ Open Respiratory Medicine 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. BMJ Publishing Group 2023-09-29 /pmc/articles/PMC10546128/ /pubmed/37775286 http://dx.doi.org/10.1136/bmjopen-2022-070864 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Respiratory Medicine
Xia, Ruyu
Fei, Yutong
Zhang, Lishan
Jie, Zhijun
Fan, Xiaoyun
Dai, Mengyuan
Moore, Michael
Willcox, Merlin
Hu, Xiaoyang
Francis, Nick
Liang, Changhao
Fei, Guanghe
Liu, Jianping
Shufeng Jiedu capsule for acute exacerbation of chronic obstructive pulmonary disease: a protocol of multicentre, randomised, double-blind, placebo-controlled trial
title Shufeng Jiedu capsule for acute exacerbation of chronic obstructive pulmonary disease: a protocol of multicentre, randomised, double-blind, placebo-controlled trial
title_full Shufeng Jiedu capsule for acute exacerbation of chronic obstructive pulmonary disease: a protocol of multicentre, randomised, double-blind, placebo-controlled trial
title_fullStr Shufeng Jiedu capsule for acute exacerbation of chronic obstructive pulmonary disease: a protocol of multicentre, randomised, double-blind, placebo-controlled trial
title_full_unstemmed Shufeng Jiedu capsule for acute exacerbation of chronic obstructive pulmonary disease: a protocol of multicentre, randomised, double-blind, placebo-controlled trial
title_short Shufeng Jiedu capsule for acute exacerbation of chronic obstructive pulmonary disease: a protocol of multicentre, randomised, double-blind, placebo-controlled trial
title_sort shufeng jiedu capsule for acute exacerbation of chronic obstructive pulmonary disease: a protocol of multicentre, randomised, double-blind, placebo-controlled trial
topic Respiratory Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10546128/
https://www.ncbi.nlm.nih.gov/pubmed/37775286
http://dx.doi.org/10.1136/bmjopen-2022-070864
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