Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: Study protocol for a randomised controlled trial

Gu, X, Zhang, A, Coyle, M, Mo, X, Lenon, G, Cranswick, N, Chen, D and Xue, C 2015, 'Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: Study protocol for a randomised controlled trial', Trials, vol. 16, 294, pp. 1-6.


Document type: Journal Article
Collection: Journal Articles

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Title Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: Study protocol for a randomised controlled trial
Author(s) Gu, X
Zhang, A
Coyle, M
Mo, X
Lenon, G
Cranswick, N
Chen, D
Xue, C
Year 2015
Journal name Trials
Volume number 16
Article Number 294
Start page 1
End page 6
Total pages 6
Publisher BioMed Central Ltd.
Abstract Background: Atopic eczema or atopic dermatitis is a chronic inflammatory skin disease. Current conventional medical treatment for moderate and severe atopic eczema is not satisfactory. There is promising evidence derived from randomised clinical trials to support the clinical use of Chinese herbal medicine in the management of atopic eczema. However, the available evidence is compromised by the high risk of bias associated with most of the included trials. Therefore, well-designed and adequately powered randomised clinical trials are needed. The primary aim of this trial is to evaluate the efficacy and safety of oral ingestion of an oral Chinese herbal formula (Pei Tu Qing Xin granules; PTQX) in children aged between 6 and 16 years with moderate to severe atopic eczema. Methods/Design: We have designed a randomised, double-blind, placebo-controlled, two-arm, parallel clinical trial with 12 weeks of treatment and a 4-week follow-up period. A pilot study with 30 participants will be conducted at the RMIT University in Australia to determine the feasibility of the full-scale randomised clinical trial (N = 124). Eczema Area and Severity Index score will be the primary outcome. Secondary outcome measures include change in symptoms using the Patient-Oriented Eczema Measure, the Children's Dermatology Life Quality Index and the use of concomitant medicines. Safety parameters include report of adverse events and pathology tests during the trial period. Discussion: Key elements for conducting a high-quality randomised clinical trial have been addressed in this protocol. Findings from the proposed trial will provide critical evidence regarding Chinese herbal medicine treatment for atopic eczema.
Subject Dermatology
Traditional Chinese Medicine and Treatments
Paediatrics
Keyword(s) Atopic dermatitis
Atopic eczema
Chinese herbal medicine
Clinical trial
PTQX
RCT
DOI - identifier 10.1186/s13063-015-0806-y
Copyright notice © Gu et al. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
ISSN 1745-6215
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