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

NCT00741936 | Completed Phase 2 Results DMC

• 1 other identifier: PID-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Gastrointestinal Disorders; Constipation

Keywords

Functional Constipation; Chinese Herbal Medicine; MaZiRenWan; Hemp Seed Pill; Traditional Chinese Medicine; Herbal Medicine

Outcome Measures

Primary Outcomes (1)

• Responder of Complete Spontaneous Bowel Movement (CSBM)

  Patients with a mean increase of ≧1 complete spontaneous bowel movement(CSBM)/wk compared with the baseline(wk1-2) will be defined as responders. CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.

  End of treatment (wk10)

Secondary Outcomes (10)

• Responder of Complete Spontaneous Bowel Movement (CSBM)

  End of follow up (wk18)

• Bowel Movement

  Baseline(Wk1&2), Within treatment(Wk3-10) & Within follow-up(Wk11-18)

• Complete Spontaneous Bowel Movement (CSBM)

  Baseline(Wk1&2), Within treatment(Wk3-10), Within follow-up(Wk11-18)

• Changes on Individual Symptom Scores

  Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18)

• Global Symptoms Improvement

  Wk 6, 10 & wk 18

Study Arms (2)

MaZiRenWan (MZRW)

EXPERIMENTAL

MZRW granule, 7.5g/sachet

Drug: MaZiRenWan (MZRW)

Placebo

PLACEBO COMPARATOR

Placebo granule, 7.5g/sachet

Drug: Placebo

Interventions

MaZiRenWan (MZRW) DRUG

MZRW granule dissolved in 150ml hot water (oral), 7.5g/sachet, twice daily

Also known as: Hemp Seed Pill

MaZiRenWan (MZRW)

Placebo DRUG

Placebo granule dissolved in 150ml hot water (oral), 7.5g/sachet, twice daily

Also known as: MZRW Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• Food and Health Bureau, Hong Kong: collaborator
• Purapharm International (Hk) Ltd.: collaborator

Study Sites (1)

Hong Kong Baptist University Mr. & Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre

Hong Kong, China

Location

Related Publications (1)

• 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.

  PMID: 21045817 RESULT

Related Links

• Abstract

MeSH Terms

Conditions

Gastrointestinal Diseases; Constipation

Interventions

ma zi ren wan

Condition Hierarchy (Ancestors)

Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Prof. Zhao-xiang Bian
• Organization: Hong Kong Baptist University

bzxiang@hkbu.edu.hk

(852) 3411 2905

Study Officials

• Zhao-xiang Bian, PhD

  Hong Kong Baptist University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Clinical Division

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 24, 2016
• Results First Posted: December 16, 2011

Record last verified: 2015-03

Locations

CN (1)