Status:
COMPLETED
Effect of taVNS on Abdominal Pain and Other Symptoms in Constipation-predominant Irritable Bowel Syndrome
Lead Sponsor:
Tongji University
Collaborating Sponsors:
Shanghai East Hospital
Conditions:
Constipation-predominant Irritable Bowel Syndrome
Abdominal Pain
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study aims to investigate the effects and possible mechanisms of transcutaneous auricular vagal nerve stimulation (taVNS) on abdominal pain and other symptoms in patients with IBS-C.
Detailed Description
This study is designed as an early-feasibility, single-center, single-blinded, randomized controlled trial (RCT), in which subjects are consented, undergo a baseline assessment, and receive taVNS or s...
Eligibility Criteria
Inclusion
- willing to sign a written informed consent form
- met the Rome IV diagnostic criteria for IBS-C
Exclusion
- history of previous abdominal surgery (other than appendectomy)
- presence of carcinoma
- any organic diseases causing constipation or neurologic diseases such as multiple sclerosis, rachischisis, Parkinson's disease, or spinal cord injury
- taking antidepressant agents including tricyclic antidepressants and selective serotonin reuptake inhibitors
- serious concomitant disease of the heart, liver, kidney, or diabetes
- pregnancy or lactation
- participating in another trial or enrolled in a trial during the past month
- allergic reaction to surface electrodes
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05392439
Start Date
March 1 2020
End Date
December 15 2020
Last Update
May 31 2022
Active Locations (1)
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1
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, China, 200120