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A randomized, double-blind, placebo-controlled multicenter clinical trial of Xiehuang Jiejing granule in the treatment of cough variant asthma in children

Cough variant asthma (CVA), also called concealed asthma or allergic asthma, is the most common cause of chronic cough in children. The disorder is mainly characterized by a nonproductive dry cough associated with a high recurrence rate that is conventionally treated with antibiotics, anti-inflammat...

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Autores principales: Qiao, Yi-Na, Lin, Shuang-Zhu, Duan, Xiao-Zheng, Yang, Ming-Hang, Zhang, Xiao-Fang, Li, Jing-Jing, Kang, Sai-Nan, Wang, Yu-Ting, Zhang, Ying, Feng, Xiao-Chun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9678501/
https://www.ncbi.nlm.nih.gov/pubmed/36401471
http://dx.doi.org/10.1097/MD.0000000000031636
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author Qiao, Yi-Na
Lin, Shuang-Zhu
Duan, Xiao-Zheng
Yang, Ming-Hang
Zhang, Xiao-Fang
Li, Jing-Jing
Kang, Sai-Nan
Wang, Yu-Ting
Zhang, Ying
Feng, Xiao-Chun
author_facet Qiao, Yi-Na
Lin, Shuang-Zhu
Duan, Xiao-Zheng
Yang, Ming-Hang
Zhang, Xiao-Fang
Li, Jing-Jing
Kang, Sai-Nan
Wang, Yu-Ting
Zhang, Ying
Feng, Xiao-Chun
author_sort Qiao, Yi-Na
collection PubMed
description Cough variant asthma (CVA), also called concealed asthma or allergic asthma, is the most common cause of chronic cough in children. The disorder is mainly characterized by a nonproductive dry cough associated with a high recurrence rate that is conventionally treated with antibiotics, anti-inflammatory medications, cough suppressants, or expectorants. For millennia, Chinese herbal medicine (CHM) has been used widely in China to treat pediatric CVA cases, although high-quality evidence of CHM efficacy is lacking. In this study, the effectiveness and safety of Xiehuangjiejing (XHJJ) granule will be evaluated when used alone to treat children with CVA. METHODS AND ANALYSIS: A randomized, double-blind, parallel, placebo-controlled multicenter trial will be conducted over the course of 2 weeks. A total of 180 CVA patients of ages between 4 and 7 years old will be randomly assigned to the experimental group (XHJJ granules, 4.5 g administered 3 times daily) or control group (matched placebo, 4.5 g administered 3 times daily) in a 2:1 ratio based on subject number per group, respectively. The trial will consist of a 7-day medical interventional stage and a 7-day follow-up stage. On day 7 of the follow-up stage, an evaluation of all subjects will be carried out to assess cough symptom score as the primary outcome and several secondary outcomes, including TCM (traditional Chinese medicine) syndrome score, lung function, and dosage of salbutamol aerosol inhaler therapy. Safety assessments will also be evaluated during the trial. DISCUSSION: The aim of this study was to examine the effectiveness and safety of Xiehuangjiejing (XHJJ) granule using a trial protocol designed to yield high-quality, statistically robust results for use in evaluating CHM as a treatment for CVA in children.
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spelling pubmed-96785012022-11-22 A randomized, double-blind, placebo-controlled multicenter clinical trial of Xiehuang Jiejing granule in the treatment of cough variant asthma in children Qiao, Yi-Na Lin, Shuang-Zhu Duan, Xiao-Zheng Yang, Ming-Hang Zhang, Xiao-Fang Li, Jing-Jing Kang, Sai-Nan Wang, Yu-Ting Zhang, Ying Feng, Xiao-Chun Medicine (Baltimore) 3800 Cough variant asthma (CVA), also called concealed asthma or allergic asthma, is the most common cause of chronic cough in children. The disorder is mainly characterized by a nonproductive dry cough associated with a high recurrence rate that is conventionally treated with antibiotics, anti-inflammatory medications, cough suppressants, or expectorants. For millennia, Chinese herbal medicine (CHM) has been used widely in China to treat pediatric CVA cases, although high-quality evidence of CHM efficacy is lacking. In this study, the effectiveness and safety of Xiehuangjiejing (XHJJ) granule will be evaluated when used alone to treat children with CVA. METHODS AND ANALYSIS: A randomized, double-blind, parallel, placebo-controlled multicenter trial will be conducted over the course of 2 weeks. A total of 180 CVA patients of ages between 4 and 7 years old will be randomly assigned to the experimental group (XHJJ granules, 4.5 g administered 3 times daily) or control group (matched placebo, 4.5 g administered 3 times daily) in a 2:1 ratio based on subject number per group, respectively. The trial will consist of a 7-day medical interventional stage and a 7-day follow-up stage. On day 7 of the follow-up stage, an evaluation of all subjects will be carried out to assess cough symptom score as the primary outcome and several secondary outcomes, including TCM (traditional Chinese medicine) syndrome score, lung function, and dosage of salbutamol aerosol inhaler therapy. Safety assessments will also be evaluated during the trial. DISCUSSION: The aim of this study was to examine the effectiveness and safety of Xiehuangjiejing (XHJJ) granule using a trial protocol designed to yield high-quality, statistically robust results for use in evaluating CHM as a treatment for CVA in children. Lippincott Williams & Wilkins 2022-11-18 /pmc/articles/PMC9678501/ /pubmed/36401471 http://dx.doi.org/10.1097/MD.0000000000031636 Text en Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY) (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle 3800
Qiao, Yi-Na
Lin, Shuang-Zhu
Duan, Xiao-Zheng
Yang, Ming-Hang
Zhang, Xiao-Fang
Li, Jing-Jing
Kang, Sai-Nan
Wang, Yu-Ting
Zhang, Ying
Feng, Xiao-Chun
A randomized, double-blind, placebo-controlled multicenter clinical trial of Xiehuang Jiejing granule in the treatment of cough variant asthma in children
title A randomized, double-blind, placebo-controlled multicenter clinical trial of Xiehuang Jiejing granule in the treatment of cough variant asthma in children
title_full A randomized, double-blind, placebo-controlled multicenter clinical trial of Xiehuang Jiejing granule in the treatment of cough variant asthma in children
title_fullStr A randomized, double-blind, placebo-controlled multicenter clinical trial of Xiehuang Jiejing granule in the treatment of cough variant asthma in children
title_full_unstemmed A randomized, double-blind, placebo-controlled multicenter clinical trial of Xiehuang Jiejing granule in the treatment of cough variant asthma in children
title_short A randomized, double-blind, placebo-controlled multicenter clinical trial of Xiehuang Jiejing granule in the treatment of cough variant asthma in children
title_sort randomized, double-blind, placebo-controlled multicenter clinical trial of xiehuang jiejing granule in the treatment of cough variant asthma in children
topic 3800
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9678501/
https://www.ncbi.nlm.nih.gov/pubmed/36401471
http://dx.doi.org/10.1097/MD.0000000000031636
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