As a lifetime disorder, ulcerative colitis (UC) is an inflammatory bowel disease (IBD) that affects quality of life and also demands long-term interventions. In spite of considerable side effects and sometimes restricted uses, efficient medications are available for UC treatment. Some in vitro and in vivo examinations have correspondingly introduced ginger and its active components with antioxidant, anti-inflammatory, and anti-ulcerative properties. Therefore, this trial aims to evaluate the effect of ginger supplementation on patients with active UC. This study will be a 12-week, double-blind, parallel-group, randomized, controlled trial (RCT) in which 44 patients will be allocated to ginger and placebo groups receiving basic routine treatments plus ginger or placebo capsules, respectively. The primary outcomes are inflammatory markers (TNF-α and hs-CRP) and total antioxidant capacity. The findings of this trial will provide evidence on the effect of ginger on patients with active UC. Iranian Registry of Clinical Trials, IRCT20190129042552N1. Registered on 21 June 2019.

中文翻译：

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生姜治疗活动性溃疡性结肠炎患者：一项随机对照试验的研究方案


作为一种终生疾病，溃疡性结肠炎 (UC) 是一种影响生活质量且需要长期干预的炎症性肠病 (IBD)。尽管存在相当大的副作用并且有时使用受到限制，但有效的药物可用于 UC 治疗。一些体外和体内试验也相应介绍了生姜及其具有抗氧化、抗炎、抗溃疡特性的活性成分。因此，本试验旨在评估补充生姜对活动性UC患者的效果。这项研究将是一项为期 12 周的双盲、平行组、随机对照试验 (RCT)，其中 44 名患者将被分配到生姜组和安慰剂组，分别接受基本常规治疗加生姜或安慰剂胶囊。主要结果是炎症标志物（TNF-α 和 hs-CRP）和总抗氧化能力。该试验的结果将为生姜对活动性溃疡性结肠炎患者的疗效提供证据。伊朗临床试验登记处，IRCT20190129042552N1。注册日期：2019 年 6 月 21 日。