Abstract

BackgroundAtopic 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/DesignWe 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.DiscussionKey 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.Trial registrationAustralian New Zealand Clinical Trials Registry Identifier: ACTRN12614001172695. Date of Registration: 7 November 2014.

Highlights

  • Atopic eczema or atopic dermatitis is a chronic inflammatory skin disease

  • Key elements for conducting a high-quality randomised clinical trial have been addressed in this protocol

  • Atopic eczema (AE) or atopic dermatitis is an inflammatory skin disease characterised by redness of the skin, scaling, swelling, accentuation of the hair follicles and lichenification that result from chronic scratching owing

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Summary

Discussion

Determination of the trial timeline is one of the challenges of the trial design. It depends on many factors, such as how long the effect of the intervention may last, costs of the trial and tolerability by and compliance of the participants. The trial duration of 16 weeks has been determined after consideration of these issues This protocol was developed according to the guidelines of Australian Clinical Trial Handbook [23] and follows the nine CONSORT checklist items for RCTs of herbal medicines [24]. Authors’ contributions SXG, CCX, ALZ, DC and MEC designed and developed the trial protocol. Authors’ information SXG: BMed, MAppSc, PhD candidate, RMIT University ALZ: BMed, MPH, PhD, Head, Discipline of Chinese Medicine, School of the Health Sciences, RMIT University MEC: BlthSc(Acup), PhD, Research Fellow, Discipline of Chinese Medicine, School of the Health Sciences, RMIT University XM: BMed, MMed, PhD, Dermatologist, Guangdong Provincial Hospital of Chinese Medicine GBL: BHlthSc (Hons), PhD, Lecturer, Discipline of Chinese Medicine, School of the Health Sciences, RMIT University NEC: MBBS, BMedSc, LLB, FRACP, Paediatrician and Clinical Pharmacologist, Royal Children’s Hospital, Melbourne DC: BMed, MMed, Dermatologist, Guangdong Provincial Hospital of Chinese Medicine; Principal, Guangdong Provincial Academy of Chinese Medical Sciences CCX: BMed, PhD, Head, School of the Health Sciences, RMIT University; Senior Principal Research Fellow, Guangdong Provincial Academy of Chinese Medical Sciences

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