Institute of Digestive Diseases, Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
School of Public Health, Nanjing Medical University, Nanjing, China.
Trials. 2021 Jan 13;22(1):55. doi: 10.1186/s13063-020-05012-8.
Ulcerative colitis (UC) is an intestinal inflammatory disease characterized by inflammation of the colonic mucosa. With unknown pathogenesis, it has become a chronic lifetime disorder worldwide. In patients with moderately active UC, several therapies (e.g., aminosalicylates, corticosteroids, immunosuppressants, and biologics) are recommended for induction (or maintenance) of remission. Given the side effects and disease burden, it is difficult for most patients to achieve ideal treatment goals in clinical practice. Chinese herbal medicine (CHM), as a complementary therapy, has been widely used in the management of UC in China. Qing-Chang-Hua-Shi granule (QCHS) is a classical Chinese herbal formula. Our preliminary study suggested that the QCHS decoction has a significant effect on patients with moderately active UC. However, its effectiveness and safety has not been evaluated convincingly. Therefore, we designed this protocol to investigate the efficacy of QCHS granule for moderately active UC.
This is a multicenter, randomized, double-blind, placebo-controlled, superiority trial. A total of 120 patients with moderately active UC will be recruited from 10 hospitals in China. Each eligible participant will be randomly assigned to receive QCHS granule or placebo for 12 weeks. Both groups will be given basic treatment with mesalazine (4 g/day). The primary outcomes are the clinical response (remission) rate. The secondary outcomes are health-related quality of life, endoscopic response rate, mucosal healing rate, and inflammatory markers (e.g., fecal calprotectin and CRP). The whole study period will last 36 weeks, including 24 weeks follow-up time. According to the intention-to-treat principle, variables will be assessed at 2, 4, 6, 8, 10, and 12 weeks after study commencement.
This is the first randomized controlled clinical study protocol regarding Chinese herbal extract granules in the management of moderately active UC. We aim to investigate the superiority of QCHS granules over placebo in terms of induction of remission. If the trial shows significant benefits of QCHS granules, it will help clinical practitioners, UC patients, and policymakers make more informed choices in the decision-making.
Chinese Clinical Trial Registry ChiCTR-IOR-14005554 . Registered on 27 November 2014.
溃疡性结肠炎（UC）是一种以结肠黏膜炎症为特征的肠道炎症性疾病。由于发病机制不明，它已成为全球范围内的一种慢性终身疾病。在中度活动期 UC 患者中，氨基水杨酸盐、皮质类固醇、免疫抑制剂和生物制剂等多种疗法被推荐用于诱导（或维持）缓解。鉴于其副作用和疾病负担，大多数患者在临床实践中难以达到理想的治疗目标。中药（CHM）作为一种补充疗法，在中国被广泛用于 UC 的治疗。清肠化湿颗粒（QCHS）是一种经典的中药方剂。我们的初步研究表明，QCHS 汤对中度活动期 UC 患者有显著疗效。然而，其疗效和安全性尚未得到令人信服的评估。因此，我们设计了本方案来研究 QCHS 颗粒治疗中度活动期 UC 的疗效。
这是一项多中心、随机、双盲、安慰剂对照、优效性试验。将从中国 10 家医院招募 120 名中度活动期 UC 患者。每个符合条件的参与者将被随机分配接受 QCHS 颗粒或安慰剂治疗 12 周。两组均给予美沙拉嗪（4g/天）的基础治疗。主要结局是临床缓解（缓解）率。次要结局是健康相关生活质量、内镜缓解率、黏膜愈合率和炎症标志物（如粪便钙卫蛋白和 CRP）。整个研究周期为 36 周，包括 24 周的随访时间。根据意向治疗原则，在研究开始后 2、4、6、8、10 和 12 周评估变量。
这是第一个关于中药提取物颗粒治疗中度活动期 UC 的随机对照临床研究方案。我们旨在研究 QCHS 颗粒在诱导缓解方面是否优于安慰剂。如果试验显示 QCHS 颗粒有显著的益处，它将有助于临床医生、UC 患者和决策者在决策中做出更明智的选择。
中国临床试验注册中心 ChiCTR-IOR-14005554。注册于 2014 年 11 月 27 日。
