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

NCT01695850 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2020-05-12

No results posted yet for this study

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.

Conditions

  • Functional Constipation
  • Gastrointestinal Disorders

Interventions

DRUG

MZRW

Patients are instructed to dissolve a sachet of granules (7.5g) in 150ml of hot water; they take this solution orally twice daily for 8 weeks.

DRUG

Senna

Patients are instructed to take 2 tablets at the bedtime for 8 weeks.

DRUG

placebo

The placebo MZRW is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%) and caramel (0.34%) to achieve color, smell, taste and texture comparable to MZRW granules.The placebo Senna is made of starch and colour to achieve comparable appearance to Senokot.

Sponsors & Collaborators

  • Queen Elizabeth Hospital, Hong Kong

    collaborator OTHER

  • Prince of Wales Hospital, Shatin, Hong Kong

    collaborator OTHER

  • Hong Kong Baptist University

    lead OTHER

Principal Investigators

  • Zhao Xiang Bian, MD, Ph. D · School of Chinese Medicine, Hong Kong Baptist University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01695850 on ClinicalTrials.gov