A Double-blinded,Double-dummy Clinical Trial of Chinese Herbal Medicine (MaZiRenWan) for Functional Constipation

Launched by HONG KONG BAPTIST UNIVERSITY · Sep 27, 2012

Keywords

ClinConnect Summary

Functional constipation (FC) is a common clinical complaint. Despite the effectiveness of MaZiRenWan (MZRW) for alleviating FC symptoms has been proofed in the previous study.Given the results of the dose determination study and placebo-controlled study of MZRW, we hypothesize that MZRW is more useful than senna (senokot), a commonly used WM drug for constipation, for FC patients in excessive TCM syndrome.This is a prospective, double-blind, double dummy, randomized, controlled trial. After a 2-week run-in, eligible FC patients (Rome III) in excessive TCM syndrome will randomly be assigned ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • either gender aged 18 to 65 years
• • have FC diagnosed as Rome III criterial
• • have diagnosis of Excessive Constipation according to the TCM theory
• • complete spontaneous bowel movement (CSBM) ≦2times/w
• • severity of constipation≧3pts (7 pts scale from 0 to 6pts) and the overall scoring of constipation-related symptoms≧6pts (6items in 7pts scale) for self symptom assessment in the run-in period
• • normal colonic evaluation (colonoscopy or barium enema) within 12 months
• • 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 diseases (i.e. cancer and acute present asthma)
• • allergy to CHM (i.e. G6PD deficiency), senna and tartrazine
• • pregnancy or breast-feeding
• • psychiatric or addictive disorders