Randomized controlled trial of acupuncture treatment of Irritable Bowel Syndrome

Phase 1

Recruiting

• Conditions: Irritable Bowel Syndrome

• Registration Number: ITMCTR2000004189
• Lead Sponsor: Beijing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subjects aged 18-70 years old;
2. Subjects with IBS according to Rome IV diagnostic criteria;
3. Patients with a course of at least 6 months;
4. Patients with IBS symptom severity score > 75 at baseline;
5. Patients with normal occult blood in stool in recent one month;
6. Subjects who voluntarily participated in this trial and signed informed consent.
Note: all the above conditions were met before inclusion.

Exclusion Criteria

1. Patients with intestinal organic lesions (including but not limited to ulcerative colitis and colorectal cancer) found by previous colonoscopy, barium meal fluoroscopy and abdominal ultrasound;
2. Patients with one or more of the following warning symptoms: hematochezia, fecal occult blood test positive, anemia, abdominal mass, ascites, fever, weight loss;
3. Patients with severe diseases of cardiovascular system, endocrine system and rheumatic immune system that affect the judgment of disease condition;
4. The patients with unconsciousness, inability to express subjective discomfort symptoms and severe mental disorder diagnosed clearly;
5. Patients with severe depression (SDS total score > 56);
6. Pregnant or lactating women;
7. Patients who have received acupuncture treatment for IBS in recent three months;
Note: patients who meet any one of the above criteria are excluded.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IBS symptom severity scale;

Secondary Outcome Measures

Name	Time	Method
umber of bowel movements per weekNumber of bowel movements per week;IBS Symptom Relief Assessment Form;Work and Social Adjustment Scale;the Bristol scale; the Irritable Bowel Syndrome-Quality of Life Measure (IBS-QOL scale);SAS, SDS;