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

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ClinicalTrials.gov Identifier: NCT01695850
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : November 21, 2018
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

Tracking Information
First Submitted Date  ICMJE September 27, 2012
First Posted Date  ICMJE September 28, 2012
Last Update Posted Date November 21, 2018
Study Start Date  ICMJE June 2013
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2012)
the responder rate for CSBM during the treatment period [ Time Frame: 8 weeks ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01695850 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
  • the responder rate for CSBM during the follow-up period [ Time Frame: 8 weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Assessed by determining the important adverse events reported in the participants ' diaries, follow-up interviews,and clinical laboratory evaluationse.g., liver and renal function.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2012)
  • the responder rate for CSBM during the follow-up period [ Time Frame: 8 weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Assessed by determining the important adverse events reported in the participants ' diaries, follow-up interviews,and clinical laboratory evaluationse.g., liver and renal function.
  • changes of the parametres measured by anorectal manometry, [ Time Frame: 18 weeks ]
    Water perfused system with anorectal catheter with 4 side holes was used to record length of anal canal or high-pressure zone, resting pressure of anal canal, and rectoanal inhibitory reflex
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Double-blinded,Double-dummy Clinical Trial of Chinese Herbal Medicine (MaZiRenWan) for Functional Constipation
Official Title  ICMJE Chinese Herbal Medicine (MaZhiRenWan) for Functional Constipation: a Prospective, Double-blinded, Double-dummy, Randomized Controlled Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Functional Constipation
  • Gastrointestinal Disorders
Intervention  ICMJE
  • 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: 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.
Study Arms  ICMJE
  • 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).
    Interventions:
    • Drug: MZRW
    • Drug: placebo
  • Active Comparator: Senna
    Senna is a stimulant laxative which facilitates the passage of stools by altering intestinal electrolyte transport and increasing intestinal motor activity.
    Interventions:
    • Drug: Senna
    • Drug: placebo
  • Placebo Comparator: Placebo
    Placebo MZRW and Placebo Senna
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2012)
291
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01695850
Other Study ID Numbers  ICMJE HHSRF09101501
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ZhaoXiang Bian, Hong Kong Baptist University
Study Sponsor  ICMJE Hong Kong Baptist University
Collaborators  ICMJE
  • Queen Elizabeth Hospital, Hong Kong
  • Prince of Wales Hospital, Shatin, Hong Kong
Investigators  ICMJE
Principal Investigator: Zhao Xiang Bian, MD, Ph. D School of Chinese Medicine, Hong Kong Baptist University
PRS Account Hong Kong Baptist University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP