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NOT YET RECRUITING
NCT07899944
NA

Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State

Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

View on ClinicalTrials.gov

Summary

Study Title: Randomized Controlled Clinical Study on Acupuncture Combined with Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome with Anxiety State. This single-center, randomized, single-blinded sham-controlled trial enrolls adults aged 18-70 with constipation-predominant irritable bowel syndrome (IBS-C) and anxiety. All participants receive standardized weekly acupuncture for 4 weeks. Participants are randomly assigned 1:1 to either real daily home Transcutaneous Electrical Acupoint Stimulation(TEAS)at Zusanli acupoint or sham non-acupoint TEAS. The total study period lasts approximately 10 weeks, including 2-week screening, 4-week intervention and 4-week post-treatment follow-up. The primary outcome is weekly complete spontaneous bowel movements (CSBM) at week 4. Secondary outcomes cover anxiety, sleep quality, abdominal symptoms, quality of life and safety. Researchers will test whether adding real home-based TEAS to acupuncture improves bowel and emotional symptoms, and evaluate treatment safety and tolerability.

Official title: Randomized Controlled Clinical Study on Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2026-10

Completion Date

2028-03

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

PROCEDURE

Acupuncture

Participants receive standardized acupuncture once weekly for 4 weeks.

DEVICE

Transcutaneous Electrical Acupoint Stimulation

Participants receive daily 1-hour stimulation for 4 weeks, with stimulation applied to unilateral ST36 (Zusanli).

DEVICE

Sham Transcutaneous Electrical Acupoint Stimulation

Participants receive daily 1-hour sham stimulation for 4 weeks, with stimulation applied to a non-acupoint site distant from ST36 (Zusanli) and not located along major meridians.