Journal article

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

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

TRIALS | BIOMED CENTRAL LTD | Published : 2015


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..

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Funding Acknowledgements

The authors thank Associate Professor Clifford Da Costa for his advice on sample size calculation. The authors also thank the Jiangyin Tianjiang Pharmaceutical Co. Ltd., the manufacturer of PTQX, for providing the trial medications. The company will not be involved in any other aspect of trial design or implementation or in the analysis or publication of the results. This project is funded by the China-Australia International Research Centre for Chinese Medicine and the School of Health Sciences, RMIT University. The trial is sponsored by RMIT University and Guangdong Provincial Academy of Chinese Medical Sciences, China.