Xiaohui Guo1,2,3, Meiling Xuan1,2,3, Huan Zheng4, Shumin Qin4, Haomeng Wu4, Shaogang Huang5,6, Zehuai Wen7,8,9. 1. Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. 2. Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou, China. 3. State Key Laboratory of Chinese Medicine Dampness Syndrome, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. 4. Department of Gastroenterology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. 5. State Key Laboratory of Chinese Medicine Dampness Syndrome, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. huangshaogang@gzucm.edu.cn. 6. Department of Gastroenterology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. huangshaogang@gzucm.edu.cn. 7. Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. wenzh@gzucm.edu.cn. 8. Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou, China. wenzh@gzucm.edu.cn. 9. State Key Laboratory of Chinese Medicine Dampness Syndrome, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. wenzh@gzucm.edu.cn.
Abstract
BACKGROUND:Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common chronic digestive disease. Recent observational studies have reported that the Chinese herbal formula Huoxiang Zhengqi (HXZQ) can relieve IBS-D symptoms, but no high-level evidence is presented. Therefore, we want to evaluate the efficacy and safety of HXZQ for IBS-D patients. METHODS: This is a double-blind, randomized, placebo-controlled trial. The 212 eligible patients with IBS-D will be randomly assigned to receive either HXZQ oral liquid or a placebo, at a 1:1 ratio, for 4 weeks with a 4-week follow-up period. Adequate relief will be the primary outcome measures. IBS symptom severity score, IBS quality-of-life questionnaire, EQ-5D-5L, and Chinese medicine symptom questionnaire will be the secondary outcome measures. DISCUSSION: This trial aims to demonstrate the efficacy and safety of HXZQ for IBS-D, which is expected to be an effective IBS-D treatment. TRIAL REGISTRATION: The trial was registered with the Chinese Clinical Trial Registry, ChiCTR1900026837 . Registered on 24 October 2019.
RCT Entities:
BACKGROUND:Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common chronic digestive disease. Recent observational studies have reported that the Chinese herbal formula Huoxiang Zhengqi (HXZQ) can relieve IBS-D symptoms, but no high-level evidence is presented. Therefore, we want to evaluate the efficacy and safety of HXZQ for IBS-D patients. METHODS: This is a double-blind, randomized, placebo-controlled trial. The 212 eligible patients with IBS-D will be randomly assigned to receive either HXZQ oral liquid or a placebo, at a 1:1 ratio, for 4 weeks with a 4-week follow-up period. Adequate relief will be the primary outcome measures. IBS symptom severity score, IBS quality-of-life questionnaire, EQ-5D-5L, and Chinese medicine symptom questionnaire will be the secondary outcome measures. DISCUSSION: This trial aims to demonstrate the efficacy and safety of HXZQ for IBS-D, which is expected to be an effective IBS-D treatment. TRIAL REGISTRATION: The trial was registered with the Chinese Clinical Trial Registry, ChiCTR1900026837 . Registered on 24 October 2019.
Authors: Wai K Leung; Justin C Y Wu; S M Liang; L S Chan; Francis K L Chan; He Xie; Sara S L Fung; Aric J Hui; Vincent W S Wong; Chun-Tao Che; Joseph J Y Sung Journal: Am J Gastroenterol Date: 2006-07 Impact factor: 10.864
Authors: E Corazziari; P Bytzer; M Delvaux; G Holtmann; J R Malagelada; J Morris; S Muller-Lissner; R C Spiller; J Tack; P J Whorwell Journal: Aliment Pharmacol Ther Date: 2003-09-15 Impact factor: 8.171