search
Back to results

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

Primary Purpose

Functional Constipation, Gastrointestinal Disorders

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
MZRW
Senna
placebo
Sponsored by
Hong Kong Baptist University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Constipation focused on measuring Randomized controlled trial, Drugs,Chinese Herbal, Constipation/drug therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • School of Chinese Medicine, Hong Kong Baptist University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

MZRW

Senna

Placebo

Arm Description

MZRW 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 is a stimulant laxative which facilitates the passage of stools by altering intestinal electrolyte transport and increasing intestinal motor activity.

Placebo MZRW and Placebo Senna

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the responder rate for CSBM during the follow-up period
Participants with a mean increase of complete spontaneous bowel movement (CSBM)>=1 movement per week compared with the last 14 days of the run-in period were defined as responders
Individual assessment of constipation and related symptoms
severity of constipation, sensation of straining, incomplete evacuation, bloating, abdominal pain / cramping, nausea, and passing of gas) was recorded using a 7-point ordinal scale (0 = not at all and 6 = very severe
the changes of colonic transit time
It is estimated by using a commercially available radio-opaque Sitzmarks capsule (Konsyl Pharmaceuticals, US). Each gelatine capsule contained 24 barium sulphate embedded polyvinyl chloride markers measuring 1mmx4.5mm. Plain radiographs of the abdomen will be obtained after the swallow of capsule for five days (120 hours) before and after 8 weeks treatment period.
Global symptom assessment
Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply "improved" for score 4 to 6, "same" for score 3 or "worse" for score 0 to 2.
Success of blinding
the success of blinding is evaluated for both investigator and patients as to whether CHM, WM or placebo had been taken
safety profiles
Assessed by determining the important adverse events reported in the participants ' diaries, follow-up interviews,and clinical laboratory evaluationse.g., liver and renal function.

Full Information

First Posted
September 27, 2012
Last Updated
May 10, 2020
Sponsor
Hong Kong Baptist University
Collaborators
Queen Elizabeth Hospital, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT01695850
Brief Title
A Double-blinded,Double-dummy Clinical Trial of Chinese Herbal Medicine (MaZiRenWan) for Functional Constipation
Official Title
Chinese Herbal Medicine (MaZhiRenWan) for Functional Constipation: a Prospective, Double-blinded, Double-dummy, Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Baptist University
Collaborators
Queen Elizabeth Hospital, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Functional constipation (FC) is a common clinical complaint. Despite the effectiveness of MaZiRenWan (MZRW) for alleviating FC symptoms has been proofed in the previous study.Given the results of the dose determination study and placebo-controlled study of MZRW, we hypothesize that MZRW is more useful than senna (senokot), a commonly used WM drug for constipation, for FC patients in excessive TCM syndrome.This is a prospective, double-blind, double dummy, randomized, controlled trial. After a 2-week run-in, eligible FC patients (Rome III) in excessive TCM syndrome will randomly be assigned to CHM arm (MZRW and WM placebo), WM arm (senna and CHM placebo) or placebo arm (CHM placebo and WM placebo). Patients will undergo an 8-week treatment and an 8-week follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation, Gastrointestinal Disorders
Keywords
Randomized controlled trial, Drugs,Chinese Herbal, Constipation/drug therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
291 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MZRW
Arm Type
Experimental
Arm Description
MZRW 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).
Arm Title
Senna
Arm Type
Active Comparator
Arm Description
Senna is a stimulant laxative which facilitates the passage of stools by altering intestinal electrolyte transport and increasing intestinal motor activity.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo MZRW and Placebo Senna
Intervention Type
Drug
Intervention Name(s)
MZRW
Other Intervention Name(s)
Hemp Seed Pill
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Senna
Other Intervention Name(s)
Senokot
Intervention Description
Patients are instructed to take 2 tablets at the bedtime for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
the responder rate for CSBM during the treatment period
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
the responder rate for CSBM during the follow-up period
Description
Participants with a mean increase of complete spontaneous bowel movement (CSBM)>=1 movement per week compared with the last 14 days of the run-in period were defined as responders
Time Frame
8 weeks
Title
Individual assessment of constipation and related symptoms
Description
severity of constipation, sensation of straining, incomplete evacuation, bloating, abdominal pain / cramping, nausea, and passing of gas) was recorded using a 7-point ordinal scale (0 = not at all and 6 = very severe
Time Frame
18 weeks
Title
the changes of colonic transit time
Description
It is estimated by using a commercially available radio-opaque Sitzmarks capsule (Konsyl Pharmaceuticals, US). Each gelatine capsule contained 24 barium sulphate embedded polyvinyl chloride markers measuring 1mmx4.5mm. Plain radiographs of the abdomen will be obtained after the swallow of capsule for five days (120 hours) before and after 8 weeks treatment period.
Time Frame
18 weeks
Title
Global symptom assessment
Description
Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply "improved" for score 4 to 6, "same" for score 3 or "worse" for score 0 to 2.
Time Frame
18 weeks
Title
Success of blinding
Description
the success of blinding is evaluated for both investigator and patients as to whether CHM, WM or placebo had been taken
Time Frame
18 weeks
Title
safety profiles
Description
Assessed by determining the important adverse events reported in the participants ' diaries, follow-up interviews,and clinical laboratory evaluationse.g., liver and renal function.
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Xiang Bian, MD, Ph. D
Organizational Affiliation
School of Chinese Medicine, Hong Kong Baptist University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Chinese Medicine, Hong Kong Baptist University
City
Hong Kong
State/Province
Hong Kong
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29654915
Citation
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.
Results Reference
derived
PubMed Identifier
24180235
Citation
Zhong 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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs