Abstract
BackgroundAtopic 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.MethodsThis 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.DiscussionThe 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 registrationChinese 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.
Highlights
Atopic dermatitis (AD) is a complex, common inflammatory skin disease
For different Adverse events (AEs) severities, a ranksum test will be performed to analyze the independent ordered multiple category data between the two groups. This is a protocol for a multi-center, double blinded, randomized, placebo-controlled trial. This trial will be conducted in outpatient settings with experienced investigators, and participants will be recruited from 7 hospitals in different Chinese cities
The goal of this trial is to determine whether treatment with Huoxiang Zhengqi (HXZQ) oral liquid is of benefit to AD/eczema patients with the Chinese medicine (CM) dampness pattern
Summary
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
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
