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Efficacy and safety of modified Xiao-Feng Powder in the treatment of chronic urticaria: protocol of a randomized double-blind placebo-controlled study

BACKGROUND: Chronic Urticaria (CU), a common skin disorder known as Yin Zhen in Chinese medicine, is characterized by recurrent, pruritic, pink-to-red edematous lesions and wheals on the skin. Xiao-Feng Powder (XFP, meaning Wind-Dispersing Powder), is reported to be one of the most frequently used C...

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Autores principales: Hung, Hing Yu, Song, Tianhe, Loo, Steven King Fan, Chan, Kam Leung, Ching, Jessica Yuet Ling, Sum, Chi Him, Lo, Louis Cho Wing, Chia, Sarah Chon Pin, Ho, Ray Tin Muk, Cheong, Pui Kuan, Siu, Tony Hon Chung, Leung, Ka Chun, Lin, Zhi-Xiu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9308295/
https://www.ncbi.nlm.nih.gov/pubmed/35869554
http://dx.doi.org/10.1186/s13020-022-00642-3
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author Hung, Hing Yu
Song, Tianhe
Loo, Steven King Fan
Chan, Kam Leung
Ching, Jessica Yuet Ling
Sum, Chi Him
Lo, Louis Cho Wing
Chia, Sarah Chon Pin
Ho, Ray Tin Muk
Cheong, Pui Kuan
Siu, Tony Hon Chung
Leung, Ka Chun
Lin, Zhi-Xiu
author_facet Hung, Hing Yu
Song, Tianhe
Loo, Steven King Fan
Chan, Kam Leung
Ching, Jessica Yuet Ling
Sum, Chi Him
Lo, Louis Cho Wing
Chia, Sarah Chon Pin
Ho, Ray Tin Muk
Cheong, Pui Kuan
Siu, Tony Hon Chung
Leung, Ka Chun
Lin, Zhi-Xiu
author_sort Hung, Hing Yu
collection PubMed
description BACKGROUND: Chronic Urticaria (CU), a common skin disorder known as Yin Zhen in Chinese medicine, is characterized by recurrent, pruritic, pink-to-red edematous lesions and wheals on the skin. Xiao-Feng Powder (XFP, meaning Wind-Dispersing Powder), is reported to be one of the most frequently used Chinese herbal formulae for CU. In this study, we aim to investigate the effectiveness and safety of modified Xiao-Feng Powder (mXFP) for the treatment of CU. METHODS: In this randomised double-blind placebo-controlled clinical trial, 58 subjects identified as having mild to severe urticaria (Urticaria activity score greater than 10) will be recruited and randomised into two groups to receive antihistamine Bilastine with either mXFP or placebo for 12 weeks, followed by post treatment visits at week 16. The primary outcome measure is the change of weekly urticaria activity score (UAS7) at week 12. Secondary outcome measures include the Urticaria Control Test (UCT), Visual Analog Scale of Itch Severity (VAS), Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL), Angioedema Activity Score (AAS), immunoglobulin E (IgE) test, gut microbiota test and use of antihistamines during study period. The trial will be conducted at three Chinese medicine clinics in Hong Kong. EXPECTED OUTCOMES: The results of this study will establish robust clinical evidence about the efficacy and safety of mXFP in the treatment of CU. A specific feature of this trial is that it is a integrative medicine trial with subjects being allowed to take the Western and Chinese medicine together for the treatment. Trial registration This is registered on ClinicalTrials.gov, ID: NCT04967092. Register date: July 19, 2021. https://clinicaltrials.gov/ct2/show/NCT04967092.
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spelling pubmed-93082952022-07-24 Efficacy and safety of modified Xiao-Feng Powder in the treatment of chronic urticaria: protocol of a randomized double-blind placebo-controlled study Hung, Hing Yu Song, Tianhe Loo, Steven King Fan Chan, Kam Leung Ching, Jessica Yuet Ling Sum, Chi Him Lo, Louis Cho Wing Chia, Sarah Chon Pin Ho, Ray Tin Muk Cheong, Pui Kuan Siu, Tony Hon Chung Leung, Ka Chun Lin, Zhi-Xiu Chin Med Research BACKGROUND: Chronic Urticaria (CU), a common skin disorder known as Yin Zhen in Chinese medicine, is characterized by recurrent, pruritic, pink-to-red edematous lesions and wheals on the skin. Xiao-Feng Powder (XFP, meaning Wind-Dispersing Powder), is reported to be one of the most frequently used Chinese herbal formulae for CU. In this study, we aim to investigate the effectiveness and safety of modified Xiao-Feng Powder (mXFP) for the treatment of CU. METHODS: In this randomised double-blind placebo-controlled clinical trial, 58 subjects identified as having mild to severe urticaria (Urticaria activity score greater than 10) will be recruited and randomised into two groups to receive antihistamine Bilastine with either mXFP or placebo for 12 weeks, followed by post treatment visits at week 16. The primary outcome measure is the change of weekly urticaria activity score (UAS7) at week 12. Secondary outcome measures include the Urticaria Control Test (UCT), Visual Analog Scale of Itch Severity (VAS), Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL), Angioedema Activity Score (AAS), immunoglobulin E (IgE) test, gut microbiota test and use of antihistamines during study period. The trial will be conducted at three Chinese medicine clinics in Hong Kong. EXPECTED OUTCOMES: The results of this study will establish robust clinical evidence about the efficacy and safety of mXFP in the treatment of CU. A specific feature of this trial is that it is a integrative medicine trial with subjects being allowed to take the Western and Chinese medicine together for the treatment. Trial registration This is registered on ClinicalTrials.gov, ID: NCT04967092. Register date: July 19, 2021. https://clinicaltrials.gov/ct2/show/NCT04967092. BioMed Central 2022-07-22 /pmc/articles/PMC9308295/ /pubmed/35869554 http://dx.doi.org/10.1186/s13020-022-00642-3 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Hung, Hing Yu
Song, Tianhe
Loo, Steven King Fan
Chan, Kam Leung
Ching, Jessica Yuet Ling
Sum, Chi Him
Lo, Louis Cho Wing
Chia, Sarah Chon Pin
Ho, Ray Tin Muk
Cheong, Pui Kuan
Siu, Tony Hon Chung
Leung, Ka Chun
Lin, Zhi-Xiu
Efficacy and safety of modified Xiao-Feng Powder in the treatment of chronic urticaria: protocol of a randomized double-blind placebo-controlled study
title Efficacy and safety of modified Xiao-Feng Powder in the treatment of chronic urticaria: protocol of a randomized double-blind placebo-controlled study
title_full Efficacy and safety of modified Xiao-Feng Powder in the treatment of chronic urticaria: protocol of a randomized double-blind placebo-controlled study
title_fullStr Efficacy and safety of modified Xiao-Feng Powder in the treatment of chronic urticaria: protocol of a randomized double-blind placebo-controlled study
title_full_unstemmed Efficacy and safety of modified Xiao-Feng Powder in the treatment of chronic urticaria: protocol of a randomized double-blind placebo-controlled study
title_short Efficacy and safety of modified Xiao-Feng Powder in the treatment of chronic urticaria: protocol of a randomized double-blind placebo-controlled study
title_sort efficacy and safety of modified xiao-feng powder in the treatment of chronic urticaria: protocol of a randomized double-blind placebo-controlled study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9308295/
https://www.ncbi.nlm.nih.gov/pubmed/35869554
http://dx.doi.org/10.1186/s13020-022-00642-3
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