Acupuncture for Patients With Diarrhea-predominant IBS or Functional Diarrhea: a Randomized Controlled Trial
Acupuncture for Functional Bowel Disease
1 other identifier
interventional
449
1 country
1
Brief Summary
This trial is to assess the effectiveness of three types of acupuncture for patients with functional diarrhea comparing to a positive drug control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2011
CompletedFirst Posted
Study publicly available on registry
May 10, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedApril 10, 2015
April 1, 2015
2.5 years
May 6, 2011
April 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average weekly stool frequency
Average weekly stool frequency, change from baseline in 4 weeks
4th week after inclusion
Secondary Outcomes (3)
Assessment score of Bristol stool scale
4th and 8th week after inclusion
Assessment score of SF-36 scale
4th and 8th after inclusion
Number of patients with adverse events after treatment
4th week after inclusion
Study Arms (4)
acupuncture group 1
EXPERIMENTALAcupoints ST25 and BL25 will be used in the group. ST25 locate at the abdomen, while BL25 locate at the back.
acupuncture group 2
EXPERIMENTALAcupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb.
acupuncture group 3
EXPERIMENTALAll acupoints used in acupuncture group1 and acupuncture group2 will be used in this group.
Loperamide
ACTIVE COMPARATORLoperamide will be used as an active comparator to the acupuncture groups.
Interventions
acupuncture group1, acupoints ST25 and BL25 will be used in this trial.
Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb.
All acupoints used in acupuncture group1 and group2 will be used in this group.
Loperamide will be used in this group for a dose of 2mg a time, three time a day.
Eligibility Criteria
You may qualify if:
- Diagnosed as diarrhoea-predominant irritable bowel syndrome according to Rome III criteria;
- Age between 18 and 65 years old;
- Did not take any medicine for bowel symptoms and attend other clinical research;
- Have inform consent signed.
You may not qualify if:
- Diarrhea caused by diseases such as infection, etc.
- Patients can't express himself clearly or with mental diseases;
- Tumor and other infectious diseases;
- With other serious diseases of Cardiovascular, liver, kidney, digestive or blood system; Pregnant women or planned to be pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First affiliated hospital of Chengdu university of TCM
Chengdu, Sichuan, 610075, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Li, MD, PhD
Chengdu University of TCM
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2011
First Posted
May 10, 2011
Study Start
August 1, 2011
Primary Completion
February 1, 2014
Study Completion
September 1, 2014
Last Updated
April 10, 2015
Record last verified: 2015-04