Wang Xiao-xiang, Luo Rui-jie, She Bin, Chen Yan, Guo Jia
Department of Integrated Traditional and Western Medicine, West China Hospital of Sichuan University, 37 Guoxue Lane, Chengdu 610041, Sichuan Province, People's Republic of China.
Trials. 2014 Jul 7;15:273. doi: 10.1186/1745-6215-15-273.
Irritable bowel syndrome (IBS) is a common gastrointestinal functional disorder with no effective therapy. Traditional Chinese medicine (TCM) is one of the most common complementary therapies in China. We designed this study to evaluate the efficacy and safety of Shun-Qi-Tong-Xie Granule (SQTX Granule), a TCM treatment, in patients with IBS with diarrhea (IBS-D).
METHODS/DESIGN: A randomised, double-blinded, placebo-controlled, multi-centre, superiority clinical trial to evaluate the efficacy and safety of SQTX Granule is proposed. Eligible patients (Rome III) with IBD-S will be randomly assigned into SQTX Granule group and the placebo group. Patients will receive a 28-day treatment and a 2-month follow-up. The primary outcome measures include the scores of IBS-quality of life (IBS-QOL) rating scale and IBS-symptom severity scale (IBS-SSS) rating scale. The secondary outcome measures include the improvement of symptom scores, and the duration of abdominal pain and diarrhea.
According to TCM theory, SQTX Granule has a regulating effect on abdominal pain, diarrhea and the syndrome of liver-spleen disharmony, which is similar to the symptoms of IBS-D. This study will provide objective evidence to evaluate the efficiency and safety of SQTX Granule in IBS-D treatment.
ChiCTR-TRC-14004241. Date of registration: 9 February 2014.
肠易激综合征（IBS）是一种常见的胃肠功能紊乱疾病，尚无有效治疗方法。中医是中国最常用的补充疗法之一。我们设计了本研究，以评估中药制剂顺气通泄颗粒（SQTX颗粒）治疗腹泻型肠易激综合征（IBS-D）患者的疗效和安全性。
方法/设计：拟进行一项随机、双盲、安慰剂对照、多中心的优效性临床试验，以评估SQTX颗粒的疗效和安全性。符合条件的IBD-S（罗马III标准）患者将被随机分为SQTX颗粒组和安慰剂组。患者将接受为期28天的治疗和2个月的随访。主要结局指标包括IBS生活质量（IBS-QOL）评定量表和IBS症状严重程度量表（IBS-SSS）评定量表的评分。次要结局指标包括症状评分的改善情况以及腹痛和腹泻的持续时间。
根据中医理论，SQTX颗粒对腹痛、腹泻及肝脾不和证具有调节作用，这与IBS-D的症状相似。本研究将为评估SQTX颗粒治疗IBS-D的有效性和安全性提供客观证据。
ChiCTR-TRC-14004241。注册日期：2014年2月9日。
