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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Gu, Sherman X. Zhang, Anthony L. Coyle, Meaghan E. Mo, Xiumei Lenon, George B. Cranswick, Noel E. Chen, DaCan Xue, Charlie C. |
| 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. |
| Related Links | https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-015-0806-y.pdf |
| Ending Page | 6 |
| Page Count | 6 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 17456215 |
| DOI | 10.1186/s13063-015-0806-y |
| Journal | Trials |
| Issue Number | 1 |
| Volume Number | 16 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2015-07-07 |
| Access Restriction | Open |
| Subject Keyword | Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Atopic dermatitis Atopic eczema Chinese herbal medicine Clinical trial PTQX RCT Medicine/Public Health |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine Pharmacology (medical) |
| Journal Impact Factor | 2/2023 |
| 5-Year Journal Impact Factor | 2.1/2023 |
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