Acupuncture for Irritable Bowel Syndrome Patients

  • STATUS
    Recruiting
  • participants needed
    120
  • sponsor
    Hong Kong Baptist University
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Updated on 16 February 2024
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acupuncture
irritable bowel syndrome

Summary

In this study, a 14-week, single blinded, randomized controlled clinical trial will be conducted to determine whether acupuncture could have significant benefits than sham acupuncture for IBS.

Description

This is a single blinded randomized sham controlled clinical trial with two arms. 120 IBS patients will be recruited. The study will cooperate with Hong Kong Baptist University, and University of Toronto. After a 2-week run-in period, eligible subjects will be randomly assigned to one of two arms, acupuncture (AC) arm and sham acupuncture (SAC) arm. Each eligible subject will go through a 2-wk run-in-period, 6-wk treatment period and follow by a 6-wk of follow-up period. Five visits in total were scheduled for each subject in week 0, week 2, week 5, week 8 and week 14.

Details
Condition Irritable Bowel Syndrome
Age 18years - 65years
Treatment Acupuncture, Sham-acupuncture
Clinical Study IdentifierNCT04387383
SponsorHong Kong Baptist University
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Fulfillment of the Rome IV criteria for IBS
IBS Symptom Severity Scale (IBS-SSS) > 75 points (a range of 0-500 points of VAS on five questions) at baseline and during the 2-week run-in period
Written informed consent

Exclusion Criteria

Pregnancy or breast-feeding
Medical history of inflammatory bowel diseases, carbohydrate malabsorption, hormonal disorder, known allergies to food additives, and/or any other serious diseases
Unstable medical conditions
Unstable mental condition or with history of mental illness
Patients who have received acupuncture treatment in last three months, or took concomitant medication with affect gastrointestinal motility or visceral sensation, such as antidiarrheal agent, antidepressant, narcotic analgesic, and anticholinergic
Alcoholism or drug abuse in past 1 year
Having needle phobia
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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