文献类型：期刊文献

英文题名：Clinical Dose-Response of Inflammation Formula Number 1 Granules Versus Traditional Decoction in the Treatment of Patients With Mild to Moderate Atopic Dermatitis: Protocol for a Multicenter Randomized Controlled Trial

作者：Li, Ding[1,2];Ma, Xin[1];Xu, Chuanbing[3];Li, Xin[2];Meng, Yang[4];Jiang, Wencheng[1];Luo, Guangpu[5];Liu, Yanping[6];Shen, Fanlingzi[1];Gao, Xiangjin[1];Wang, Ruiping[1];Li, Bin[1,7]

第一作者：Li, Ding

通信作者：Wang, RP[1]

机构：[1]Shanghai Skin Dis Hosp, Baode Rd, Shanghai 200433, Peoples R China;[2]Yueyang Hosp Integrated Tradit Chinese & Western M, Inst Dermatol, Dept Dermatol, Shanghai, Peoples R China;[3]Guangzhou Univ Chinese Med, Guangzhou, Peoples R China;[4]Third Peoples Hosp Bengbu, Dept Dermatol, Bengbu, Peoples R China;[5]Guangzhou Med Univ, Guangzhou Dermatol Hosp, Inst Dermatol, Guangzhou, Peoples R China;[6]Gansu Univ Chinese Med, Affiliated Hosp, Dept Dermatol, Lanzhou, Peoples R China;[7]Shanghai Acad Tradit Chinese Med, Inst Dermatol, Shanghai, Peoples R China

第一机构：Shanghai Skin Dis Hosp, Baode Rd, Shanghai 200433, Peoples R China

通信机构：[1]corresponding author), Shanghai Skin Dis Hosp, Baode Rd, Shanghai 200433, Peoples R China.

年份：2026

卷号：15

外文期刊名：JMIR RESEARCH PROTOCOLS

收录：WOS:【ESCI(收录号:WOS:001820697200007)】；

基金：This study was supported by the Clinical Study on Dose-Response Relationship of Yanqin Formula Number 1 Granules versus Traditional Decoction Pieces in the Treatment of Mild to Moderate Atopic Dermatitis (EF-YS-006) ; Shanghai Shenkang Second Round Three Year Action Plan for Clinical Trial Program (SHDC2022CRS053) ; Hospital Management Program of Shanghai Hospital Association (X2022117) ; Shanghai Health Bureau Clinical Research Program (202240371) ; the National Key Research and Development Program of China (2024YFC3505301 and 2024YFC3505304) ; the evidence-based dermatology base sponsored by State Administration of Traditional Chinese Medicine; High-level Chinese Medicine Key Discipline Construction Project (Integrative Chinese and Western Medicine Clinic) of National Administration of TCM (zyyzdxk-2023065) ; the National Qi-Huang scholar (grant [2025] No 182) ; Medicine + X Interdisciplinary Research Project (2025-0650-ZD-01 and 2025-0650-YB03) ; the National Natural Science Foundation of China (82575050) ; Youth Talent Promotion Project of China Association of Traditional Chinese Medicine (2024-2026) , Category B (2024-QNRC2-B04) ; Shanghai Oriental Talents Program Youth Project (Health Platform; QNWS2025050) ; and Shanghai Municipal Health Commission Traditional Chinese Medicine Standard Research Project (2025BZ004) . The funders had no role in the study design, data collection and analysis, decision to publish, or manuscript preparation.

语种：英文

外文关键词：atopic dermatitis; Inflammation Formula Number 1; randomized controlled trial; clinical trial protocol; traditional Chinese medicine

摘要：Background: Atopic dermatitis (AD) is a common inflammatory skin disease associated with substantial disease burden. Traditional Chinese medicine (TCM) has shown beneficial effects in improving AD symptoms and reducing recurrence. Inflammation Formula Number 1 (IFN-1), a TCM prescription consisting of 10 herbal ingredients, has demonstrated favorable efficacy in clinical practice. However, traditional decoction preparation is time-consuming and inconvenient for long-term standardized use. Granule formulations may improve convenience, stability, and quality control, but their dose-response relationship and equivalence to traditional decoction remain unclear. Objective: This multicenter, prospective, randomized equivalence trial aims to evaluate the efficacy, safety, and dose-response relationship of IFN-1 granule formulations compared with traditional decoction in patients with mild to moderate AD. Methods: A total of 300 patients with mild to moderate AD aged 18 to 60 years will be recruited from 5 hospitals between April 2026 and January 2027. Participants will be randomly assigned in a 2:2:1:1 ratio to the traditional decoction group (n=100, 33.3%), standard-dose granule group (n=100, 33.3%), two-thirds dose granule group (n=50, 16.7%), or one-tenth dose granule group (n=50, 16.7%). All groups will receive 4 weeks of treatment. The primary end point is the proportion of patients achieving at least 50% improvement in the Eczema Area and Severity Index (EASI) at week 4. Secondary outcomes include EASI75, EASI90, Investigator Global Assessment score of 0 or 1, body surface area involvement, Dermatology Life Quality Index, pruritus numerical rating scale, Patient-Oriented Eczema Measure, and TCM syndrome scores. Outcomes will be assessed at baseline and weeks 1, 2, and 4. Statistical analyses will be conducted using SAS (version 9.4). Equivalence will be evaluated using a 2-sided 95% CI approach with a predefined equivalence margin of-15% to +15%. Results: Funding for this study was obtained in 2025. Ethical approval was granted by the Ethics Committee of Shanghai Skin Disease Hospital in December 2025, and the trial was registered with the International Traditional Medicine Clinical Trial Registry (ITMCTR2026000452). Participant recruitment is scheduled to begin in April 2026 and continue through January 2027. No patients were recruited at the time of manuscript submission. Data analysis is expected to commence in March 2027, and the primary study findings are anticipated to be published in 2028. Conclusions: This trial will determine whether IFN-1 granules achieve efficacy comparable to traditional decoction while improving treatment convenience. The findings may provide evidence for dose optimization and standardized clinical application of TCM granule formulations in AD management. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2026000452; https://tinyurl.com/ 2zakunya