Abstract | BACKGROUND: 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. DISCUSSION: 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. TRIAL REGISTRATION: ChiCTR-TRC-14004241. Date of registration: 9 February 2014.
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Authors | Xiao-xiang Wang, Rui-jie Luo, Bin She, Yan Chen, Jia Guo |
Journal | Trials
(Trials)
Vol. 15
Pg. 273
(Jul 07 2014)
ISSN: 1745-6215 [Electronic] England |
PMID | 25002196
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Drugs, Chinese Herbal
- shun-qi-tong-xie
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Topics |
- Abdominal Pain
(drug therapy, etiology)
- Administration, Oral
- Clinical Protocols
- Diarrhea
(drug therapy, etiology)
- Double-Blind Method
- Drugs, Chinese Herbal
(administration & dosage, adverse effects, therapeutic use)
- Humans
- Irritable Bowel Syndrome
(complications, diagnosis, drug therapy)
- Medicine, Chinese Traditional
- Phytotherapy
- Plants, Medicinal
- Quality of Life
- Research Design
- Time Factors
- Treatment Outcome
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