Efficacy of WuSheZhiYang Pills in Mild-to-Moderate Atopic Dermatitis: Protocol for a Double-Blind, Randomized, Placebo-Controlled Trial
Bibliographic record
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 pills each day for 4 weeks. The primary indicator is the change in the objective Scoring Atopic Dermatitis (SCORAD) score between baseline and week 4. The secondary indicators include SCORAD at week 2 and week 8; Peak Pruritus Numerical Rating Scale (PP-NRS), Investigator's Global Assessment (IGA), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI) at week 2, week 4, and week 8; and the proportion of participants receiving remedial treatment, amount of levocetirizine tablets used, and recurrence rate at week 8. In this study, we will analyze the full analysis set and per-protocol set using SAS software version 9.4, and a 2-tailed alpha level of .05 will be viewed as statistically significant. RESULTS: The study received ethics permission in September 2024, and trial registration was completed in October 2024. Recruitment started in December 2024 and is expected to be completed by December 2025. As of June 2025, 30 participants with mild-to-moderate AD were enrolled. Data analysis will begin in January 2026. The main results of the trial are expected to be submitted for publication in peer-reviewed scientific journals in the summer of 2026. CONCLUSIONS: This study will evaluate the efficacy of WSZY pills for AD and provide additional evidence, suggest new therapeutic options for patients, and reduce their disease burden. TRIAL REGISTRATION: International Traditional Medicine Clinical Trial Registry ITMCTR2024000724; http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=bda070f8-a733-4f52-87b0-39e4be57ac00. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/77927.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.024 | 0.022 |
| Meta-epidemiology (narrow) | 0.007 | 0.004 |
| Meta-epidemiology (broad) | 0.014 | 0.006 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.003 | 0.004 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.009 | 0.008 |
| Insufficient payload (model declined to judge) | 0.053 | 0.009 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".