Meiling Xuan1,2, Xiaohui Guo1,2, Hongyi Li3, Ting Xie3, Xiumei Mo3, Zehuai Wen4,5. 1. Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, 111 Dade Road, Guangzhou, 510120, China. 2. State Key Laboratory of Dampness Syndrome of Chinese Medicine, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China. 3. Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, 111 Dade Road, Guangzhou, 510120, China. 4. Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, 111 Dade Road, Guangzhou, 510120, China. wenzh@gzucm.edu.cn. 5. State Key Laboratory of Dampness Syndrome of Chinese Medicine, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China. wenzh@gzucm.edu.cn.
Abstract
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 placebogroup, 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.
RCT Entities:
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/eczemapatients. 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.
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