A Double-blinded,Double-dummy Clinical Trial of Chinese Herbal Medicine (MaZiRenWan) for Functional Constipation
Chinese Herbal Medicine (MaZhiRenWan) for Functional Constipation: a Prospective, Double-blinded, Double-dummy, Randomized Controlled Study
1 other identifier
interventional
291
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2012
CompletedFirst Posted
Study publicly available on registry
September 28, 2012
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMay 12, 2020
May 1, 2020
2.2 years
September 27, 2012
May 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the responder rate for CSBM during the treatment period
a clinically meaningful endpoint by combining an objective measure (number of bowel movement) with a subjective measure (feelings of patients as to completeness of defecation,Patients with a mean increase of ≧1 complete spontaneous bowel movement(CSBM)/wk compared with the baseline(wk1-2) will be defined as responders
8 weeks
Secondary Outcomes (6)
the responder rate for CSBM during the follow-up period
8 weeks
Individual assessment of constipation and related symptoms
18 weeks
the changes of colonic transit time
18 weeks
Global symptom assessment
18 weeks
Success of blinding
18 weeks
- +1 more secondary outcomes
Study Arms (3)
MZRW
EXPERIMENTALMZRW is composed of Fructus Cannabis (HuoMaRen), Radix et Rhizoma Rhei (DaHuang), Radix Paeoniae Alba (BaiShao), Semen Armeniacae Amarum (KuXingRen), Fructus Aurantii Immaturus (ZhiShi) and Cortex Magnoliae Officinalis (HouPo).
Senna
ACTIVE COMPARATORSenna is a stimulant laxative which facilitates the passage of stools by altering intestinal electrolyte transport and increasing intestinal motor activity.
Placebo
PLACEBO COMPARATORPlacebo MZRW and Placebo Senna
Interventions
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.
Patients are instructed to take 2 tablets at the bedtime for 8 weeks.
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.
Eligibility Criteria
You may qualify if:
- 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
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hong Kong Baptist Universitylead
- Queen Elizabeth Hospital, Hong Kongcollaborator
- Prince of Wales Hospital, Shatin, Hong Kongcollaborator
Study Sites (1)
School of Chinese Medicine, Hong Kong Baptist University
Hong Kong, Hong Kong, China
Related Publications (2)
Zhong LLD, Cheng CW, Kun W, Dai L, Hu DD, Ning ZW, Xiao HT, Lin CY, Zhao L, Huang T, Tian K, Chan KH, Lam TW, Chen XR, Wong CT, Li M, Lu AP, Wu JCY, Bian ZX. Efficacy of MaZiRenWan, a Chinese Herbal Medicine, in Patients With Functional Constipation in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2019 Jun;17(7):1303-1310.e18. doi: 10.1016/j.cgh.2018.04.005. Epub 2018 Apr 12.
PMID: 29654915DERIVEDZhong LL, Cheng CW, Chan Y, Chan KH, Lam TW, Chen XR, Wong CT, Wu JC, Bian ZX. Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial. Trials. 2013 Nov 4;14:366. doi: 10.1186/1745-6215-14-366.
PMID: 24180235DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhao Xiang Bian, MD, Ph. D
School of Chinese Medicine, Hong Kong Baptist University
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
Study Record Dates
First Submitted
September 27, 2012
First Posted
September 28, 2012
Study Start
June 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
May 12, 2020
Record last verified: 2020-05