Acupuncture for Chronic Constipation
Randomised Controlled Trial of Acupuncture for Patients With Chronic Constipation
1 other identifier
interventional
80
1 country
1
Brief Summary
Since there have been few advances for constipation in laxative treatment in the last 50 years, this study is designed to evaluate the efficacy and safety of acupuncture for patients with chronic constipation based on the theory of traditional Chinese Medicine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2008
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
August 31, 2008
CompletedFirst Posted
Study publicly available on registry
September 3, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedMay 12, 2010
May 1, 2010
1.5 years
August 31, 2008
May 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
score of questionnaire of constipation symptoms
every month
Secondary Outcomes (8)
score of questionnaire of quality of life
every month
amount of laxative use
every week
frequency of enema/suppository use/digital maneuver
every week
stool amount
every week
stool consistency
every week
- +3 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALS
SHAM COMPARATORInterventions
Frequency of electrostimulation: 15Hz; Duration of electrostimulation: 20min;
Superficial acupuncture needle stimulation at non-acupoints with TENS applied for seconds
Eligibility Criteria
You may qualify if:
- men or non-pregnant women who are at least 20 years old
- who meet any one of the following three criteria: 1.the one who meets RomeIII criteria; 2.at least once a week of enema/suppository in past three months; 3.laxative use in more than half time of last three months
You may not qualify if:
- known colorectal cancer, anal abscess, anal fissure, rectocele, inflammatory bowel disease, megacolon or mechanical bowel obstruction
- unknown cause of gastrointestinal bleeding or acute infection
- history of alcohol or drug abuser
- women who are pregnant, as determined by a urine pregnancy test
- history of adverse reaction to (electro)acupuncture
- received herb or acupuncture therapy within one month prior to enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital, Yun-Lin Branch
Douliu, 640, Taiwan
Related Publications (1)
Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003 Oct 2;349(14):1360-8. doi: 10.1056/NEJMra020995. No abstract available.
PMID: 14523145BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chien-Hsun Huang, MD, MSc
National Taiwan University Hospital, Yun-Lin Branch
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 31, 2008
First Posted
September 3, 2008
Study Start
October 1, 2008
Primary Completion
April 1, 2010
Study Completion
May 1, 2010
Last Updated
May 12, 2010
Record last verified: 2010-05