Comparison of TCM and Laxatives for Adults With Chronic Constipation

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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 care.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Cathartics; Lactulose; Laxatives

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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