Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 22, 2025
Date Accepted: Jun 12, 2025
Efficacy of WuSheZhiYang pills in mild-to-moderate atopic dermatitis: Protocol for a double-blind, randomized, placebo-control trial
ABSTRACT
Background:
Atopic dermatitis (AD) is a recurrent, inflammatory and chronic skin disease that influences over 200 million individuals around the world and is viewed as an important health problem due to its elevated prevalence, long course of disease and heavy disease burden. WuSheZhiYang (WSZY) Pills is composed of 11 Chinese herbs and has effects of nourishing blood, drying dampness and relieving itching. In clinical practice, WSZY pills is recommended for itching skin diseases, but high quality clinical trial evidence is still limited.
Objective:
In this study, we will implement a double blind, randomized, placebo-control trail to evaluate the efficacy of the WSZY pills for AD.
Methods:
In this study, we will recruit 60 mild-to moderate AD patients in Shanghai Skin Diseases Hospital during December 2024 and December 2025. In this study, 60 AD patients aged 18 to 65 years with both of males and females will be randomly assigned (2:1) to the treatment group (urea ointment and WSZY pills, n=40) and the control group (urea ointment and WSZY placebo, n=20), and each patients in both groups will receive 4 weeks treatment and then 4 weeks follow-up, respectively. The primary indicator is the change in objective score of atopic dermatitis (SCORAD) between baseline and week 4. The secondary indicators include SCORAD at week 2 and 8, Peak Pruritus Numerical Rating Scale (PP-NRS), Investigator's Global Assessment (IGA), Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI) at week 2, 4, and 8, the proportion of participants receiving remedial treatment, the amount of levocetirizine tablets used and the recurrence rate at week 8. In this study, we will analyze the Full Analysis Set (FAS) and Per Protocol Set (PPS), by using SAS software version 9.4, and a two-tailed alpha level of 0.05 will be viewed as statistical significance.
Results:
Recruitment has began in December 2024, and the results are expected in December 2025. Data analysis will begin in January 2026 and results will be published in Summer 2026.
Conclusions:
This study will evaluate the efficacy of the WSZY pills for AD and provide additional evidence, suggest new therapeutic options for patients, and reduce their diseases burden. Clinical Trial: International Traditional Medicine Clinical Trial Registry ITMCTR2024000724; http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=bda070f8-a733-4f52-87b0-39e4be57ac00
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