Status:
COMPLETED
Comparison of TCM and Laxatives for Adults With Chronic Constipation
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Chronic Constipation
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare the therapeutic efficacy, safety, cost-effectiveness and maintenance effect between Chinese herbal formula and lactulose on chronic constipation in long-term car...
Detailed Description
Although many people regard regular defecation as important factor to maintain healthy, constipation is still a common problem in general population. According to some surveys, constipation affects ap...
Eligibility Criteria
Inclusion
- men and non-pregnant women who are at least 20 years of age
- patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication
- the one who meet any one of the following three criteria: 1.RomeIII criteria; 2.at least once a week of enema/suppository use/digital maneuver in past three months; 3.laxative use in more than half time of last three months
Exclusion
- known severe renal or hepatic insufficiency,
- known colorectal cancer, anal abscess, anal fistula, anal fissure, rectocele, inflammatory bowel diseases, or gastrointestinal obstruction;
- unknown cause of gastrointestinal bleeding or acute infection
- neuromuscular dystrophy or spinal cord injury induced constipation
- history of drug abuser
- unstable psychiatric disorders
- women who are pregnant, as determined by a urine pregnancy test
- use of an investigational drug (within 30days prior to enrolled)
- known allergies to the component of study medication
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00745147
Start Date
July 1 2008
End Date
April 1 2010
Last Update
May 4 2010
Active Locations (1)
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1
National Taiwan University Hospital, Yun-Lin Branch
Douliu, Yun-Lin, Taiwan, 640