Department of Rheumatology, the First Affiliated Hospital, Anhui University of Chinese Medicine, Hefei 230031, Anhui Province, China; E-mail:
J Integr Med. 2013 Nov;11(6):428-34. doi: 10.3736/jintegrmed2013059.
Rheumatoid arthritis (RA), as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA.
This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1:1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo (imitation leflunomide). The control group will receive leflunomide and an herbal placebo (imitation Xinfeng Capsule). The American College of Rheumatology (ACR) Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate (ACR20), which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment.
The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA.
This trial has been registered in ClinicalTrials.gov. The identifier is NCT01774877.
类风湿关节炎（RA）是一种常见的系统性炎症性自身免疫性疾病，大约每 100 个人中就有 1 人会患病。由于目前对 RA 的病因和发病机制尚不清楚，因此还没有有效的治疗方法。新风胶囊是一种专利中药，近年来已用于 RA 的治疗。尽管有报道称其具有临床疗效，但尚无大规模、多中心、随机试验支持新风胶囊治疗 RA。因此，我们设计了一项随机、双盲、多中心、安慰剂对照试验，以评估新风胶囊治疗 RA 的疗效和安全性。
这是一项为期 12 周的随机、安慰剂对照、双盲、多中心 RA 治疗试验。参与者将按照 1:1 的比例随机分配到实验组和对照组。实验组患者将服用新风胶囊和药物安慰剂（模仿来氟米特），对照组患者将服用来氟米特和中药安慰剂（模仿新风胶囊）。将采用美国风湿病学会（ACR）的 RA 标准来衡量新风胶囊的疗效。主要疗效指标为达到 ACR20 应答率（ACR20）的研究参与者百分比，该指标将在随机分组后每 4 周测量一次。次要疗效指标包括 ACR50 和 ACR70 应答率、药物的副作用、疾病活动评分 28（DAS28）、RA 生物标志物、生活质量和手部及腕部 X 射线。前四项次要疗效指标将每 4 周测量一次，其余指标将在基线和治疗 12 周后测量。
该试验的结果将有助于评估新风胶囊在 RA 治疗中的有效性和安全性。
该试验已在 ClinicalTrials.gov 上注册。标识符为 NCT01774877。
