Clinical trial NCT04387383: Acupuncture for Irritable Bowel Syndrome Patients
Official title: Acupuncture for Irritable Bowel Syndrome Patients: A Single-blinded Randomized Sham-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blinded, randomized, sham-controlled clinical trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change on IBS-symptom severity scale
timeFrame: 0,8,14 weeks
measure: Change on Hamilton Depression Rating Scale (HAMD-17)
timeFrame: 0,8,14 weeks
measure: Change on Clinical Global Impression-severity (CGI-S)
timeFrame: 0,8,14 weeks
measure: Change on Self-Rating Depression Scale (SDS)
timeFrame: 0,8,14 weeks
measure: Change on IBS Quality of Life (IBS-QoL)
timeFrame: 0,8,14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: Linda Zhong
state: Kowloon
Study officials:
affiliation: Hong Kong Chinese Medicine Clinical Study Centre
name: Zhaoxiang Bian, MD., Ph.D
role: STUDY_DIRECTOR
References:
citation: Zhong LLD, Lam TF, Yang W, Zheng Y, Lyu Z, Bian Z. Electro-acupuncture for irritable bowel syndrome patients: study protocol for a single-blinded randomized sham-controlled clinical trial. Trials. 2021 Sep 15;22(1):619. doi: 10.1186/s13063-021-05563-4.