Hung Hing Yu, Song Tianhe, Loo Steven King Fan, Chan Kam Leung, Ching Jessica Yuet Ling, Sum Chi Him, Lo Louis Cho Wing, Chia Sarah Chon Pin, Ho Ray Tin Muk, Cheong Pui Kuan, Siu Tony Hon Chung, Leung Ka Chun, Lin Zhi-Xiu
Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR, China.
School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR, China.
Chin Med. 2022 Jul 22;17(1):87. doi: 10.1186/s13020-022-00642-3.
Chronic Urticaria (CU), a common skin disorder known as Yin Zhen in Chinese medicine, is characterized by recurrent, pruritic, pink-to-red edematous lesions and wheals on the skin. Xiao-Feng Powder (XFP, meaning Wind-Dispersing Powder), is reported to be one of the most frequently used Chinese herbal formulae for CU. In this study, we aim to investigate the effectiveness and safety of modified Xiao-Feng Powder (mXFP) for the treatment of CU.
In this randomised double-blind placebo-controlled clinical trial, 58 subjects identified as having mild to severe urticaria (Urticaria activity score greater than 10) will be recruited and randomised into two groups to receive antihistamine Bilastine with either mXFP or placebo for 12 weeks, followed by post treatment visits at week 16. The primary outcome measure is the change of weekly urticaria activity score (UAS7) at week 12. Secondary outcome measures include the Urticaria Control Test (UCT), Visual Analog Scale of Itch Severity (VAS), Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL), Angioedema Activity Score (AAS), immunoglobulin E (IgE) test, gut microbiota test and use of antihistamines during study period. The trial will be conducted at three Chinese medicine clinics in Hong Kong.
The results of this study will establish robust clinical evidence about the efficacy and safety of mXFP in the treatment of CU. A specific feature of this trial is that it is a integrative medicine trial with subjects being allowed to take the Western and Chinese medicine together for the treatment. Trial registration This is registered on ClinicalTrials.gov, ID: NCT04967092. Register date: July 19, 2021. https://clinicaltrials.gov/ct2/show/NCT04967092 .
慢性荨麻疹（CU）是一种常见的皮肤病，中医称为“瘾疹”，其特征为皮肤反复出现瘙痒性粉红色至红色水肿性皮损和风团。消风散据报道是治疗慢性荨麻疹最常用的中药方剂之一。在本研究中，我们旨在探讨加味消风散（mXFP）治疗慢性荨麻疹的有效性和安全性。
在这项随机双盲安慰剂对照临床试验中，将招募58名确诊为轻至重度荨麻疹（荨麻疹活动评分大于10）的受试者，并随机分为两组，分别接受抗组胺药比拉斯汀联合mXFP或安慰剂治疗12周，随后在第16周进行治疗后随访。主要结局指标是第12周时每周荨麻疹活动评分（UAS7）的变化。次要结局指标包括荨麻疹控制试验（UCT）、瘙痒严重程度视觉模拟量表（VAS）、慢性荨麻疹生活质量问卷（CU-Q2oL）、血管性水肿活动评分（AAS）、免疫球蛋白E（IgE）检测、肠道微生物群检测以及研究期间抗组胺药的使用情况。该试验将在香港的三家中医诊所进行。
本研究结果将为mXFP治疗慢性荨麻疹的疗效和安全性建立有力的临床证据。该试验的一个特点是它是一项中西医结合试验，允许受试者同时服用西药和中药进行治疗。试验注册本试验已在ClinicalTrials.gov上注册，编号：NCT04967092。注册日期：2021年7月19日。https://clinicaltrials.gov/ct2/show/NCT04967092 。
