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

NCT00741936 ↗

Phase 2 Completed 120 enrolled Hong Kong Baptist University Food and Health Bureau, Hong Kong · collab Purapharm International (Hk) Ltd. · collab

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2008-07
Primary completion: 2009-11
Completion: 2009-12

Outcome

Met primary endpoint

paper Responder rates for the HSP and placebo groups were 43.3 and 8.3% during treatment and 30.0 and 15.0% in the follow-up period, respectively (P<0.05). PMID 21045817 ↗

registry analysis (superiority or other test); MaZiRenWan (MZRW) vs Placebo; p <0.05; Chi-squared NCT00741936 ↗

Publications

Results Cheng CW, Bian ZX, Zhu LX, Wu JC, Sung JJ. Efficacy of a Chinese herbal proprietary medicine (Hemp Seed Pill) for functional constipation. Am J Gastroenterol. 2011 Jan;106(1):120-9. doi: 10.1038/ajg.2010.305. Epub 2010 Nov 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MaZiRenWan (MZRW)	Traditional medicine (herbal / TCM)	7.5 g	Oral