Evaluation of the Efficacy of Acupuncture for Irritable Bowel Syndrome with predominant Diarrhea (IBS-D)

Phase 1

Conditions: Irritable Bowel Syndrome with predominant Diarrhea (IBS-D)

Registration Number: ITMCTR2000003247

Lead Sponsor: Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Patients symptoms meet the ROME-IV criteria for IBS-D while also satisfying the IBS-SSS scale (Chinese version) is greater than 75, the fecal occult blood test must be negative, and the fecal routine test and culture are both negative not less than three times;
2. Patients aged 18 to 65 years old with the capacity to consent for participation.

Exclusion Criteria

The patients who meet either of the conditions listed below will be excluded from the study.
1. The age is below 18 or above 65. The weight loss is greater than 5 kilograms within the last three months. Patients previous medical history is significant of fecal blood, recurrent fever, tumor, and/or other gastrointestinal diseases such as inflammatory bowel disease, polyps, ischemic bowel disease, or functional diarrhea;
2. Patients have severe cardiac, hepatic, renal, and/or hematologic diseases. Patients are malnutrition. Patient should not have surgical history of anorectal procedures;
3. Patients who have received acupuncture therapy within the last thirty days or are on pharmaceutical therapy within the last two weeks are also not included in the study;
4. The females who are pregnant, breast-feeding, and/or not on contraception are also excluded;
5. The patients who participate in other studies in the last three months are also excluded.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the change of IBS-SSS comprehensive scale compared with baseline;

Secondary Outcome Measures

Name	Time	Method
The patient satisfaction evaluated on the scale from 0 to 4. The bigger the number, the more satisfied about the treatment.;the Irritable Bowel Syndrome-Quality of Life Measure (IBS-QOL scale);the change of IBS-SSS comprehensive scale and individual index compared with baseline;SAS, SDS, HAMA and HAMD scores;the Bristol scale;the response rate, defined as the improvement on IBS-SSS scales more than 50 points;Evaluation of the use of other interventions, such as antidiarrheal, antispasmodics, and their frequency and dose.;