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Clinical efficacy evaluation of taVNS for patients with IBS-D

Phase 1
Conditions
irritable bowel syndrome
Registration Number
ITMCTR2200006465
Lead Sponsor
Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

To be admitted to the study, patients must meet all six of the following criteria:
(1) The case met the above western diagnostic criteria;
(2) Blood routine, urine routine, stool routine plus occult blood, biochemical and imaging tests to exclude other serious chronic diseases;
(3) male and female patients aged 18 to 65 years;
(4) Course of disease > 6 months;
(5) No drug treatment was given within 4 weeks before enrollment;
(6) Patients and their family members shall be informed and sign informed consent.

Exclusion Criteria

Patients meeting 1 or more of the following criteria should be excluded:
(1) patients with severe liver and kidney function injury, severe heart, brain and lung diseases and severe mental diseases;
(2) patients aged under 18 years or over 65 years;
(3) during the observation period, taking other drugs, such as opioid antidiarrheal drugs or selective 5-HT reuptake inhibitors, affected the observation results;
(4) Subjects are unwilling to participate in the test or have poor compliance;
(5) pregnant or lactating women;
(6) Patients with other body surface electrical stimulation or acupuncture therapy involved in the original treatment plan.
(7) Patients with ear ulceration and other skin lesions.
(8) Patients with known hypersensitivity to trimebutin maleate.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Evaluation of curative effect of abdominal pain symptom;Evaluation of overall disease efficacy;Serum inflammatory factor;IBS Quality of Life Questionnaire score;
Secondary Outcome Measures
NameTimeMethod
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