title: Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: study protocol for a randomised controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614001172695. Date of Registration: 7 November 2014.
authors.affiliation: Traditional and Complementary Medicine Research Program, Health Innovations Research Institute and School of Health Sciences, Royal Melbourne Institute of Technology (RMIT) University, Plenty Road, P.O. Box 71, Bundoora, 3083, VIC, Australia. sherman.gu@rmit.edu.au.
authors.forename: Sherman X
authors.initials: SX
authors.lastname: Gu
authors.affiliation: Traditional and Complementary Medicine Research Program, Health Innovations Research Institute and School of Health Sciences, Royal Melbourne Institute of Technology (RMIT) University, Plenty Road, P.O. Box 71, Bundoora, 3083, VIC, Australia. tony.zhang@rmit.edu.au.
authors.forename: Anthony L
authors.initials: AL
authors.lastname: Zhang
authors.affiliation: Traditional and Complementary Medicine Research Program, Health Innovations Research Institute and School of Health Sciences, Royal Melbourne Institute of Technology (RMIT) University, Plenty Road, P.O. Box 71, Bundoora, 3083, VIC, Australia. meaghan.coyle@rmit.edu.au.
authors.forename: Meaghan E
authors.initials: ME
authors.lastname: Coyle
authors.affiliation: Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, 111 Dade Road, Guangzhou, 510120, Guangdong, China. moxiumeilsamay@163.com.
authors.forename: Xiumei
authors.initials: X
authors.lastname: Mo
authors.affiliation: Traditional and Complementary Medicine Research Program, Health Innovations Research Institute and School of Health Sciences, Royal Melbourne Institute of Technology (RMIT) University, Plenty Road, P.O. Box 71, Bundoora, 3083, VIC, Australia. george.lenon@rmit.edu.au.
authors.forename: George B
authors.initials: GB
authors.lastname: Lenon
authors.affiliation: Royal Children's Hospital, Murdoch Children's Research Institute, University of Melbourne, 50 Flemington Road, Parkville, 3052, VIC, Australia. noel.cranswick@rch.org.au.
authors.forename: Noel E
authors.initials: NE
authors.lastname: Cranswick
authors.affiliation: Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, 111 Dade Road, Guangzhou, 510120, Guangdong, China. 4910702@163.com.|The Guangdong Provincial Academy of Chinese Medical Sciences, 111 Dade Road, Guangzhou, 510120, Guangdong, China. 4910702@163.com.
authors.forename: DaCan
authors.initials: D
authors.lastname: Chen
authors.affiliation: Traditional and Complementary Medicine Research Program, Health Innovations Research Institute and School of Health Sciences, Royal Melbourne Institute of Technology (RMIT) University, Plenty Road, P.O. Box 71, Bundoora, 3083, VIC, Australia. charlie.xue@rmit.edu.au.|The Guangdong Provincial Academy of Chinese Medical Sciences, 111 Dade Road, Guangzhou, 510120, Guangdong, China. charlie.xue@rmit.edu.au.
authors.forename: Charlie C
authors.initials: CC
authors.lastname: Xue
mesh_terms: D000293:Adolescent; D000367:Age Factors; D002648:Child; D002985:Clinical Protocols; D003876:Dermatitis, Atopic / Q000175:diagnosis / Q000188:drug therapy*; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D010865:Pilot Projects; D012107:Research Design; D012720:Severity of Illness Index; D012867:Skin / Q000187:drug effects* / Q000473:pathology; D013997:Time Factors; D016896:Treatment Outcome; D014739:Victoria
chemical_list: D003879:Dermatologic Agents; D004365:Drugs, Chinese Herbal; C000606437:pei tu qing xin