Efficacy of WuSheZhiYang Pills in Mild-to-Moderate Atopic Dermatitis: Protocol for a Double-Blind, Randomized, Placebo-Controlled 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 are composed of 11 Chinese herbs and have the effects of nourishing the blood, drying dampness, and relieving itching. In clinical practice, WSZY pills are 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-controlled trial to evaluate the efficacy of WSZY pills for mild-to-moderate AD. We hypothesized that WSZY pills can effectively alleviate the disease condition of patients with mild-to-moderate AD.
Methods: In this study, we will recruit 60 patients with mild-to-moderate in Shanghai Skin Diseases Hospital from December 2024 through December 2025. In this study, 60 male and female patients with AD aged 18 years to 65 years will be randomly assigned (2:1) to the treatment group (urea ointment and WSZY pills; n=40) or control group (urea ointment and placebo WSZY pills; n=20), and both groups will receive 4 weeks of treatment and 4 weeks of follow-up. The treatment group will receive 3 sessions of urea ointment and 7.5 g of WSZY pills each day for 4 weeks, and the control group will also receive 3 sessions of urea ointment and 7.5 g of placebo WSZY…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 200 participants or records.
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