Lee Seunghoon, Cho Yeeun, Kim Jihye, Kang Jung Won, Yoon Ga Young, Lee Jun-Hwan, Jung So-Young, Kwon Ojin, Shin Kyung-Min, Lee Jae-Dong
Department of Acupuncture & Moxibustion Medicine, Kyung Hee University Korean Medicine Hospital, 23 Kyunghee dae-ro, Dongdaemun-gu, Seoul, 02447, South Korea.
Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, South Korea.
Trials. 2018 Sep 3;19(1):471. doi: 10.1186/s13063-018-2849-3.
This study aims to assess the efficacy and safety of geonchildan, a Korean traditional herbal medicine, for patients with active rheumatoid arthritis (RA) and evaluate the feasibility of a large-scale confirmatory clinical trial.
METHODS/DESIGN: This is a randomized, double-blind, placebo-controlled, parallel two-arm pilot trial in Seoul, Korea. Altogether, 30 patients diagnosed with RA for at least 3 months and with a Disease Activity Score for 28 joints (DAS28) ≥ 3.2 will be enrolled. Participants are randomly assigned to one of two groups, the experimental group or the placebo group, in a 1:1 ratio and will make four scheduled visits. The participants will be administered geonchildan or a placebo three times per day for 12 weeks. The change in DAS28 will be examined as the primary efficacy outcome. The secondary efficacy outcomes include the proportion of patients achieving ACR20, ACR50, ACR70, and EULAR responses; the DAS28 sub-items; the consumption of medication; Korean Health Assessment Questionnaire scores; inflammatory parameters; and the Korean medical diagnostic pattern indicator. Adverse events and laboratory test results will be recorded to evaluate safety. The process, resources used, and management of the study will also be assessed to determine the feasibility of a large-scale trial.
This is the first clinical trial to explore the efficacy and safety of geonchildan in patients with active RA. If the superiority of geonchildan versus the placebo is demonstrated and the study design is feasible, this study could form the foundation for a large-scale clinical trial. The results will be published in a peer-reviewed journal.
Clinical Research Information Service, KCT0001943 . Registered on 14 June 2016.
本研究旨在评估韩国传统草药geonchildan对活动性类风湿关节炎（RA）患者的疗效和安全性，并评估大规模验证性临床试验的可行性。
方法/设计：这是一项在韩国首尔进行的随机、双盲、安慰剂对照、平行双臂试点试验。总共将招募30名被诊断为RA至少3个月且28个关节疾病活动评分（DAS28）≥3.2的患者。参与者按1:1的比例随机分配到实验组或安慰剂组中的一组，并将进行四次预定访视。参与者将每天服用geonchildan或安慰剂三次，持续12周。将检查DAS28的变化作为主要疗效指标。次要疗效指标包括达到美国风湿病学会（ACR）20、ACR50、ACR70和欧洲抗风湿病联盟（EULAR）反应的患者比例；DAS28子项目；药物消耗；韩国健康评估问卷评分；炎症参数；以及韩国医学诊断模式指标。将记录不良事件和实验室检查结果以评估安全性。还将评估研究过程、使用的资源和管理情况，以确定大规模试验的可行性。
这是第一项探索geonchildan对活动性RA患者疗效和安全性的临床试验。如果geonchildan相对于安慰剂的优越性得到证实且研究设计可行，本研究可为大规模临床试验奠定基础。研究结果将发表在同行评审期刊上。
韩国临床研究信息服务中心，KCT0001943。于2016年6月14日注册。
