A Dose Determination Study of Chinese Herbal Medicine for Functional Constipation

Summary

Functional constipation (FC) is common with 14.3% estimated prevalence in Hong Kong, but treatment for this condition in conventional medicine is suboptimal. Complementary and alternative medicines, especially Chinese herbal medicine (CHM) are used frequently by patients with FC, but there is little research evidence about these commonly used CHM. The purpose of the study is evaluate the efficacy and safety of CHM, as well as determining the optimal dosage.

Timeline

Start

2006-10

Primary completion

2007-08

Completion

2007-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); Low Dose Group vs Median Dose Group vs High Dose Group; p <0.05; Chi-squared NCT00299975 ↗

paper The dose of 7.5 g b.i.d. showed better therapeutic effect than that of 2.5 and 5.0 g b.i.d. PMID 21045817 ↗

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)	2.5 g	Oral
Subject	MaZiRenWan (MZRW)	Traditional medicine (herbal / TCM)	5 g	Oral
Subject	MaZiRenWan (MZRW)	Traditional medicine (herbal / TCM)	7.5 g	Oral

Indications