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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003247
Enrollment
Unknown
Registered
2020-04-27
Start date
2020-05-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome with predominant Diarrhea (IBS-D)

Interventions

Control Group:Sham Acupuncture
Experimental group:Acupuncture

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
the change of IBS-SSS comprehensive scale compared with baseline;

Secondary

MeasureTime frame
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.;

Countries

China

Contacts

Public ContactShanshan Li

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

lishanshan722@126.com+86 13521739047

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026