Status:
COMPLETED
An Effectiveness and Safety Study of Chinese Herbal Medicine for Functional Constipation
Lead Sponsor:
Hong Kong Baptist University
Collaborating Sponsors:
Food and Health Bureau, Hong Kong
Purapharm International (Hk) Ltd.
Conditions:
Functional Gastrointestinal Disorders
Constipation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Functional constipation (FC) is a common complaint in clinical practice, but treatment for this condition in conventional medicine is suboptimal. Complementary and alternative medicines, especially Ch...
Detailed Description
Constipation is a common gastrointestinal complaint in clinical practice, which affects in estimated 12%-19% of American, 14% of Asian, and up to 27% of the population depending on demographic factor,...
Eligibility Criteria
Inclusion
- Meet of Rome III diagnostic criteria of functional constipation
- Meet the diagnosis of Excessive Constipation according to the TCM theory
- Age of 18 to 65 years (inclusive)
- Complete spontaneous bowel movement (CSBM)≦2times/wk
- Severity of constipation≧4pts (7 pts scale from 0 to 6pts) and the overall scoring of constipation-related symptoms≧8pts (6items in 7pts scale) for self symptom assessment in the run-in period
- Normal colonic evaluation (colonoscopy or barium enema) within 5 years
- Normal liver and renal function in blood test within 3 months
Exclusion
- Drug-induced constipation
- Secondary causes of constipation (i.e. medical history of diabetes mellitus and thyroid disease)
- Abdominal surgery (i.e. Caesarean operation)
- Severe disease (i.e. cancer and acute present asthma)
- Allergy to CHM (i.e. G6PD deficiency)
- Pregnancy or breast-feeding
- Psychiatric or addictive disorders
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00741936
Start Date
July 1 2008
End Date
December 1 2009
Last Update
June 24 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hong Kong Baptist University Mr. & Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre
Hong Kong, China