草药配方括苍正气散治疗伴有胃肠道症状的特应性皮炎的安全性和有效性：一项随机对照试验方案
Safety and efficacy of an herbal formula, Gwakhyangjeonggi-san on atopic dermatitis with gastrointestinal symptoms: Protocol for a randomized controlled trial.
作者信息
Son Mi Ju, Kim Min Hee, Kang Minseo, Kim Young-Eun, Jung Jeeyoun, Choi Inhwa
机构信息
Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon.
Department of Ophthalmology, Otolaryngology and Dermatology of Korean Medicine, Kyung Hee University Hospital at Gangdong, Seoul.
出版信息
Medicine (Baltimore). 2020 Jul 10;99(28):e20675. doi: 10.1097/MD.0000000000020675.
INTRODUCTION
Gwakhyangjeonggi-san (GJS) is an herbal formula with anti-inflammatory and anti-allergic properties that is broadly used to treat a wide range of diseases including gastrointestinal disorders and allergic diseases. There have been several clinical studies conducted on its effects on atopic dermatitis (AD). So far, no randomized controlled trials have been conducted. Here, we describe the protocol for a randomized controlled study designed to investigate the efficacy and safety of GJS for treating patients with AD that have gastrointestinal symptoms.
METHODS AND ANALYSIS
A randomized, double-blind, placebo-controlled, parallel-group, clinical trial has been designed to investigate the clinical efficacy and safety of GJS on patients with AD that have gastrointestinal symptoms. A total of 58 participants with AD will be recruited and randomly allocated to the GJS or placebo group in a 1:1 ratio. The participants will be administered GJS or placebo granules 3 times a day for 8 weeks. Data will be collected from the participants at baseline and after 4 and 8 weeks. The primary outcome measure will be the mean change in the SCORing of Atopic Dermatitis (SCORAD) index from baseline to 8 weeks. The secondary outcomes will include the eczema area and severity index (EASI), dermatology life quality index (DLQI), EuroQoL 5 dimensions 5 levels (EQ-5D-5L), and immunological factors. The Korean Gastrointestinal Symptom Rating Scale (KGSRS), Nepean Dyspepsia Index will also be obtained for assessing the gastrointestinal status.
DISCUSSION
The findings of this study are expected to provide evidence on the safety and effectiveness of GJS and for treating patients with AD that have gastrointestinal symptoms. Additionally, the study will explore the mechanism of GJS action via gut microbiome. This study will provide new perspectives on approaching treatment for AD.
ETHICS AND DISSEMINATION
The study protocol was approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital at Gangdong (KHNMCOH2019-06-002-001).
TRIAL REGISTRATION NUMBER
This study has been registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0004299).
引言
加味逍遥散（GJS）是一种具有抗炎和抗过敏特性的草药配方，广泛用于治疗包括胃肠道疾病和过敏性疾病在内的多种疾病。已经有几项关于其对特应性皮炎（AD）影响的临床研究。到目前为止，尚未进行随机对照试验。在此，我们描述一项随机对照研究的方案，旨在调查GJS治疗有胃肠道症状的AD患者的疗效和安全性。
方法与分析
一项随机、双盲、安慰剂对照、平行组临床试验已被设计，以研究GJS对有胃肠道症状的AD患者的临床疗效和安全性。总共将招募58名AD参与者，并以1:1的比例随机分配到GJS组或安慰剂组。参与者将每天服用GJS或安慰剂颗粒3次，持续8周。在基线以及4周和8周后从参与者收集数据。主要结局指标将是从基线到8周的特应性皮炎评分（SCORAD）指数的平均变化。次要结局将包括湿疹面积和严重程度指数（EASI）、皮肤病生活质量指数（DLQI）、欧洲五维健康量表5水平（EQ-5D-5L）以及免疫因素。还将获得韩国胃肠道症状评分量表（KGSRS）、内皮消化不良指数，以评估胃肠道状况。
讨论
本研究的结果有望为GJS治疗有胃肠道症状的AD患者的安全性和有效性提供证据。此外，该研究将通过肠道微生物群探索GJS的作用机制。本研究将为AD的治疗方法提供新的视角。
伦理与传播
该研究方案已获得庆熙大学韩国医学医院江东分院机构审查委员会的批准（KHNMCOH2019-06-002-001）。
试验注册号
本研究已在韩国国家临床试验注册中心临床研究信息服务处注册（KCT0004299）。
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