Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: Sherman X. Gu, Anthony L. Zhang, Meaghan E. Coyle, Xiumei Mo, George B. Lenon, Noel E. Cranswick, DaCan Chen, Charlie C. Xue

Published in: Trials | Issue 1/2015

Login to get access

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.

Trial registration

Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614001172​695. Date of Registration: 7 November 2014.
Literature
1.
Williams H, Bigby M, Diepgen T, Herxheimer A, Naldi L, Rzany B, editors. Evidence-based dermatology. 2nd ed. Oxford: Blackwell; 2008.
2.
3.
Martin PE, Matheson MC, Gurrin L, Burgess JA, Osborne N, Lowe AJ, et al. Childhood eczema and rhinitis predict atopic but not nonatopic adult asthma: a prospective cohort study over 4 decades. J Allergy Clin Immunol. 2011;127(6):1473–9.CrossRefPubMed
4.
Tan AU, Gonzalez ME. Management of severe atopic dermatitis in children. J Drugs Dermatol. 2012;11(10):1158–65.PubMed
5.
6.
Walling HW, Swick BL. Update on the management of chronic eczema: new approaches and emerging treatment options. Clin Cosmet Investig Dermatol. 2010;3:99–117.CrossRefPubMedPubMedCentral
7.
Denby KS, Beck LA. Update on systemic therapies for atopic dermatitis. Curr Opin Allergy Clin Immunol. 2012;12(4):421–6.CrossRefPubMed
8.
Hon KL, Ma KC, Wong Y, Leung TF, Fok TF. A survey of traditional Chinese medicine use in children with atopic dermatitis attending a paediatric dermatology clinic. J Dermatolog Treat. 2005;16(3):154–7.CrossRefPubMed
9.
Gu S, Yang AW, Xue CC, Li CG, Pang C, Zhang W, et al. Chinese herbal medicine for atopic eczema. Cochrane Database Syst Rev. 2013;9, CD008642.PubMed
10.
Huang YJ, Liu JF, Chen DC. [Professor DaCan Chen’s clinical experience in treatment of atopic dermatitis]. Chin J Dermatovenerol Integr Tradit West Med. 2010;9(3):165–6. Chinese.
11.
Sun XD. [Professor DaCan Chen’s experience in treatment of atopic dermatitis by the heart and spleen theory]. Chin J Dermatovenerol Integr Tradit West Med. 2006;5(1):55–6. Chinese.
12.
Chen DC, Liu C. Theory and practice of atopic dermatitis in its constitution, etiology and pathogenesis of the heart and spleen. J New Chin Med. 2009;41(8):7–8.
13.
14.
Shen YJ. Pharmacology of Chinese medicines. Beijing: People’s Medical Publishing House; 2000. p. 51–2. 81–83, 190–3, 208–18. Chinese.
15.
Charman C, Chambers C, Williams H. Measuring atopic dermatitis severity in randomized controlled clinical trials: what exactly are we measuring? J Investig Dermatol. 2003;120(6):932–41.CrossRefPubMed
16.
Williams HC, Burney PG, Hay RJ, Archer CB, Shipley MJ, Hunter JJ, et al. The U.K. Working Party’s Diagnostic Criteria for Atopic Dermatitis. I. Derivation of a minimum set of discriminators for atopic dermatitis. Br J Dermatol. 1994;131(3):383–96.CrossRefPubMed
17.
Emerson RM, Charman CR, Williams HC. The Nottingham Eczema Severity Score: preliminary refinement of the Rajka and Langeland grading. Br J Dermatol. 2000;142(2):288–97.CrossRefPubMed
18.
Ma YB, Sun LY, Wang P, Zhang GZ, Cai NN. Clinical observation of combination of Jianpi Runfu decoction and topical application of Gancao oil for atopic dermatitis with syndrome of spleen deficiency and blood dryness. Beijing J Tradit Chin Med. 2010;29(9):680–2.
19.
Schmitt J, Langan S, Stamm T, Williams HC, Harmonizing Outcome Measurements in Eczema (HOME) Delphi panel. Core outcome domains for controlled trials and clinical recordkeeping in eczema: international multiperspective Delphi consensus process. J Invest Dermatol. 2011;131(3):623–30.CrossRefPubMed
20.
Charman CR, Venn AJ, Williams HC. The Patient-Oriented Eczema Measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients’ perspective. Arch Dermatol. 2004;140(12):1513–9.CrossRefPubMed
21.
Lewis-Jones MS, Finlay AY. The Children’s Dermatology Life Quality Index (CDLQI): initial validation and practical use. Br J Dermatol. 1995;132(6):942–9.CrossRefPubMed
22.
23.
24.
Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med. 2006;144(5):364–7.CrossRefPubMed
Metadata
Title
Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: study protocol for a randomised controlled trial
Authors
Sherman X. Gu
Anthony L. Zhang
Meaghan E. Coyle
Xiumei Mo
George B. Lenon
Noel E. Cranswick
DaCan Chen
Charlie C. Xue
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0806-y

Other articles of this Issue 1/2015

Trials 1/2015 Go to the issue

Study protocol

A mindfulness-based stress management program and treatment with omega-3 fatty acids to maintain a healthy mental state in hospital nurses (Happy Nurse Project): study protocol for a randomized controlled trial

Study protocol

Testing the effectiveness of a mentoring intervention to improve social participation of adolescents with visual impairments: study protocol for a randomized controlled trial

Study protocol

DRAPA trial – closed-suction drains versus closed gravity drains in pancreatic surgery: study protocol for a randomized controlled trial

Update

An internal pilot study for a randomized trial aimed at evaluating the effectiveness of iron interventions in children with non-anemic iron deficiency: the OptEC trial

Study protocol

Effects of weight management program on postural stability and neuromuscular function among obese children: study protocol for a randomized controlled trial

Study protocol

Aspirin for Venous Ulcers: Randomised Trial (AVURT): study protocol for a randomised controlled trial