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
Randomized trial evaluates efficacy of granule formulations in atopic dermatitis, suggesting treatment convenience improvements.
Key Points
The trial aims to evaluate the efficacy, safety, and dose-response relationship of IFN-1 granules compared with traditional decoction in atopic dermatitis.
300 patients aged 18 to 60 years with mild to moderate AD will be recruited from 5 hospitals.
Participants will be randomly assigned to one of four treatment groups for 4 weeks.
Equivalence will be evaluated using a 2-sided 95% CI approach with a predefined equivalence margin.
Funding obtained in 2025 and ethical approval granted in December 2025.
Trial registered with International Traditional Medicine Clinical Trial Registry (ITMCTR2026000452).
Participant recruitment begins in April 2026 and expected data analysis starts in March 2027.