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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the efficacy and safety of a Chinese herbal proprietary medicine, MaZiRenWan (MZRW), by comparing with stimulant laxative western medicine (WM), senna, and placebo for patients with functional constipation (FC) in excessive TCM syndrome.

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

Details

• Lead Sponsor: Hong Kong Baptist University
• Collaborators: Prince of Wales Hospital, Shatin, Hong Kong; Queen Elizabeth Hospital, Hong Kong
• Treatments: Senna Extract; Sennoside A&B; Sennosides

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