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Traditional Chinese medicine (Shun-Qi-Tong-Xie Granule) for irritable bowel syndrome: study protocol for a randomised controlled trial.
Trials. 2014 Jul 07; 15:273.T

Abstract

BACKGROUND

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.

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.

Authors+Show Affiliations

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableDepartment of Integrated Traditional and Western Medicine, West China Hospital of Sichuan University, 37 Guoxue Lane, Chengdu 610041, Sichuan Province, People's Republic of China. jiajia818@163.com.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25002196

Citation

Wang, Xiao-xiang, et al. "Traditional Chinese Medicine (Shun-Qi-Tong-Xie Granule) for Irritable Bowel Syndrome: Study Protocol for a Randomised Controlled Trial." Trials, vol. 15, 2014, p. 273.
Wang XX, Luo RJ, She B, et al. Traditional Chinese medicine (Shun-Qi-Tong-Xie Granule) for irritable bowel syndrome: study protocol for a randomised controlled trial. Trials. 2014;15:273.
Wang, X. X., Luo, R. J., She, B., Chen, Y., & Guo, J. (2014). Traditional Chinese medicine (Shun-Qi-Tong-Xie Granule) for irritable bowel syndrome: study protocol for a randomised controlled trial. Trials, 15, 273. https://doi.org/10.1186/1745-6215-15-273
Wang XX, et al. Traditional Chinese Medicine (Shun-Qi-Tong-Xie Granule) for Irritable Bowel Syndrome: Study Protocol for a Randomised Controlled Trial. Trials. 2014 Jul 7;15:273. PubMed PMID: 25002196.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Traditional Chinese medicine (Shun-Qi-Tong-Xie Granule) for irritable bowel syndrome: study protocol for a randomised controlled trial. AU - Wang,Xiao-xiang, AU - Luo,Rui-jie, AU - She,Bin, AU - Chen,Yan, AU - Guo,Jia, Y1 - 2014/07/07/ PY - 2014/04/09/received PY - 2014/06/24/accepted PY - 2014/7/9/entrez PY - 2014/7/9/pubmed PY - 2015/4/1/medline SP - 273 EP - 273 JF - Trials JO - Trials VL - 15 N2 - BACKGROUND: 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. 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/25002196/Traditional_Chinese_medicine__Shun_Qi_Tong_Xie_Granule__for_irritable_bowel_syndrome:_study_protocol_for_a_randomised_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15-273 DB - PRIME DP - Unbound Medicine ER -