Efficacy and safety of mild moxibustion in the treatment of diarrhea-predominant irritable bowel syndrome (spleen deficiency and dampness excess syndrome): A study protocol for a randomized controlled trial
- Registration Number
- TCTR20230523002
- Lead Sponsor
- ijiang Ji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 92
1.Patients should meet both TCM and Western diagnostic criteria of IBS-D;
2.Patients at age of 18 to 65 years old;
3.No history of relevant treatment before enrollment or with discontinuation of treatment with Chinese medicine, antidiarrheal drugs and antispasmodics for more than 1 month;
4.The total score of the IBS Severity Scoring System score(IBS-SSS) is more than 75;
5.Voluntary participation in this study and signing of the informed consent form.
1.Patients with IBS-C, IBS-M, and IBS-U;
2.Patients with inflammatory bowel disease, organic intestinal lesions, peptic ulcer, infectious diarrhea;
3.Patients combined with severe cardiovascular, hepatic, renal, endocrine and hematopoietic system diseases; patients with other diseases other than diarrhea that may affect the test results that cannot be discontinued; patients with mental illness;
4.Patients who are pregnant or lactating, and those who have a birth plan from their enrollment to 1 month after the end of the trial;
5.Those who have participated in other clinical trials within 1 month.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method IBS-SSS 8 weeks includes five aspects with a score range of 0 to 100 out of 500 for each indicator
- Secondary Outcome Measures
Name Time Method Irritable Bowel Syndrome-Quality of Life(IBS-QOL)score 8 weeks The score of Irritable Bowel Syndrome-Quality of Life