Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Irritable Bowel Syndrome
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: single-blinded, randomized, sham-controlled clinical trialMasking: Single (Participant)Masking Description: Subjects of both groups will be randomly assigned to receive either electro-acupuncture or control (sham) treatment. For randomization, simple, complete non-sequential random numbers will be generated in advance by a computer program in a block of four, and kept by the principal investigator. After a patient's eligibility is confirmed, a randomization number which corresponds to the group allocation will be provided to the acupuncturist by the PI. This arrangement will ensure that the clinical assessor and participants are blinded to the allocation.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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, a...

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.

Tracking Information

NCT #
NCT04387383
Collaborators
Not Provided
Investigators
Study Director: Zhaoxiang Bian, MD., Ph.D Hong Kong Chinese Medicine Clinical Study Centre