An Effectiveness and Safety Study of Chinese Herbal Medicine for Functional Constipation

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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 Chinese herbal medicine (CHM) are used frequently by patients, however, there is little research evidence about these commonly used CHM. The purpose of the study is evaluate the efficacy and safety of an ancient CHM formula, MaZiRenWan (MZRW), by comparing with placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hong Kong Baptist University
• Collaborators: Food and Health Bureau, Hong Kong; PuraPharm International (H.K.) Ltd

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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