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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/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: ACTRN12614001172695. Date of Registration: 7 November 2014.

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  • Authors+Show Affiliations

    ,

    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.

    ,

    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.

    ,

    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.

    ,

    Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, 111 Dade Road, Guangzhou, 510120, Guangdong, China. moxiumeilsamay@163.com.

    ,

    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.

    ,

    Royal Children's Hospital, Murdoch Children's Research Institute, University of Melbourne, 50 Flemington Road, Parkville, 3052, VIC, Australia. noel.cranswick@rch.org.au.

    ,

    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.

    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.

    Source

    Trials 16: 2015 Jul 07 pg 294

    MeSH

    Adolescent
    Age Factors
    Child
    Clinical Protocols
    Dermatitis, Atopic
    Dermatologic Agents
    Double-Blind Method
    Drugs, Chinese Herbal
    Feasibility Studies
    Female
    Humans
    Male
    Pilot Projects
    Research Design
    Severity of Illness Index
    Skin
    Time Factors
    Treatment Outcome
    Victoria

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    26149448

    Citation

    Gu, Sherman X., et al. "Chinese Herbal Medicine Granules (PTQX) for Children With Moderate to Severe Atopic Eczema: Study Protocol for a Randomised Controlled Trial." Trials, vol. 16, 2015, p. 294.
    Gu SX, Zhang AL, Coyle ME, et al. Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: study protocol for a randomised controlled trial. Trials. 2015;16:294.
    Gu, S. X., Zhang, A. L., Coyle, M. E., Mo, X., Lenon, G. B., Cranswick, N. E., ... Xue, C. C. (2015). Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: study protocol for a randomised controlled trial. Trials, 16, p. 294. doi:10.1186/s13063-015-0806-y.
    Gu SX, et al. Chinese Herbal Medicine Granules (PTQX) for Children With Moderate to Severe Atopic Eczema: Study Protocol for a Randomised Controlled Trial. Trials. 2015 Jul 7;16:294. PubMed PMID: 26149448.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: study protocol for a randomised controlled trial. AU - Gu,Sherman X, AU - Zhang,Anthony L, AU - Coyle,Meaghan E, AU - Mo,Xiumei, AU - Lenon,George B, AU - Cranswick,Noel E, AU - Chen,DaCan, AU - Xue,Charlie C, Y1 - 2015/07/07/ PY - 2015/02/18/received PY - 2015/06/10/accepted PY - 2015/7/8/entrez PY - 2015/7/8/pubmed PY - 2016/4/15/medline SP - 294 EP - 294 JF - Trials JO - Trials VL - 16 N2 - 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: ACTRN12614001172695. Date of Registration: 7 November 2014. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/26149448/Chinese_herbal_medicine_granules__PTQX__for_children_with_moderate_to_severe_atopic_eczema:_study_protocol_for_a_randomised_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0806-y DB - PRIME DP - Unbound Medicine ER -