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NCT Number: NCT01695850

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

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.

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Key information

Conditions

Functional Constipation Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

School of Chinese Medicine, Hong Kong Baptist University

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MZRW

Drug

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 names: Hemp Seed Pill

Senna

Drug

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

Other names: Senokot

Placebo

Drug

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 outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Hong Kong Baptist University

Other

Collaborators

  • Prince of Wales Hospital, Shatin, Hong Kong
  • Queen Elizabeth Hospital, Hong Kong

Registry information

Official study title

Chinese Herbal Medicine (MaZhiRenWan) for Functional Constipation: a Prospective, Double-blinded, Double-dummy, Randomized Controlled Study

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 28, 2012
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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