The Chinese herbal formula Huoxiang Zhengqi for atopic dermatitis with dampness pattern (CHARM): a study protocol for a double-blinded randomized controlled trial

BACKGROUND: Atopic dermatitis (AD) is a complex, common inflammatory skin disease. The Chinese herbal formula Huoxiang Zhengqi (HXZQ) has been a common dermatosis treatment in China for many years, but there is no high-level evidence for its effect on AD/eczema. The aim of this trial is to examine the efficacy and safety of HXZQ treating AD/eczema patients. METHODS: This is a double-blind, multi-center, randomized controlled trial comparing HXZQ to a placebo. It will consist of 4 weeks’ treatment and 4 weeks of follow-up. A total of 218 participants will be randomly allocated into two groups—an HXZQ group and a placebo group, from 7 hospitals in China. Patients diagnosed with AD will be enrolled if they are in accordance with CM dampness pattern, have body surface area (BSA) of 1–10%, have investigator’s global assessment (IGA) of 1–3, have age between 18 and 70 years, and provide signed informed consent. The Eczema Area and Severity Index (EASI) is the primary outcome. The secondary outcomes are the numerical itch rating scale, IGA, BSA, Skindex-29, and EQ-5D-5L score, from baseline to the end of the treatment. Analysis will be on intention-to-treat and per-protocol subject analysis principles. DISCUSSION: The goal of this trial is to evaluate the efficacy and availability of HXZQ oral liquid in treating AD/eczema in terms of symptoms and eczematous lesions. It will also address whether it has positive effect on QoL. TRIAL REGISTRATION: Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx): Chinese herbal formula Huoxiang Zhengqi for atopic dermatitis with dampness pattern (CHARM): a double-blinded randomized controlled trial, ChiCTR1900026700. Registered on 19 October 2019.