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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Hong Kong Baptist University
Sponsor:
Collaborators:
Queen Elizabeth Hospital, Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Information provided by (Responsible Party):
ZhaoXiang Bian, Hong Kong Baptist University
ClinicalTrials.gov Identifier:
NCT01695850
First received: September 27, 2012
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Functional Constipation
Gastrointestinal Disorders
Drug: MZRW
Drug: Senna
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chinese Herbal Medicine (MaZhiRenWan) for Functional Constipation: a Prospective, Double-blinded, Double-dummy, Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Hong Kong Baptist University:

Primary Outcome Measures:
  • the responder rate for CSBM during the treatment period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    the success of blinding is evaluated for both investigator and patients as to whether CHM, WM or placebo had been taken

  • safety profiles [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
    Assessed by determining the important adverse events reported in the participants ' diaries, follow-up interviews,and clinical laboratory evaluationse.g., liver and renal function.


Estimated Enrollment: 291
Study Start Date: June 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MZRW
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).
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.
Other Name: Hemp Seed Pill
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.
Active Comparator: Senna
Senna is a stimulant laxative which facilitates the passage of stools by altering intestinal electrolyte transport and increasing intestinal motor activity.
Drug: Senna
Patients are instructed to take 2 tablets at the bedtime for 8 weeks.
Other Name: Senokot
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.
Placebo Comparator: Placebo
Placebo MZRW and Placebo Senna
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695850

Contacts
Contact: Linda LD Zhong, MD, Ph.D 852-34112501 ldzhong0305@gmail.com

Locations
China, Hong Kong
School of Chinese Medicine, Hong Kong Baptist University Recruiting
Hong Kong, Hong Kong, China
Contact: Linda LD Zhong, MD, Ph. D    852-34112501    ldzhong0305@gmail.com   
Sponsors and Collaborators
Hong Kong Baptist University
Queen Elizabeth Hospital, Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Investigators
Principal Investigator: Zhao Xiang Bian, MD, Ph. D School of Chinese Medicine, Hong Kong Baptist University
  More Information

No publications provided by Hong Kong Baptist University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ZhaoXiang Bian, Professor, Hong Kong Baptist University
ClinicalTrials.gov Identifier: NCT01695850     History of Changes
Other Study ID Numbers: HHSRF09101501
Study First Received: September 27, 2012
Last Updated: June 2, 2014
Health Authority: Hong Kong: Department of Health

Keywords provided by Hong Kong Baptist University:
Randomized controlled trial
Drugs,Chinese Herbal
Constipation/drug therapy

Additional relevant MeSH terms:
Constipation
Digestive System Diseases
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014