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Functional Gastrointestinal DisordersPhase 2NCT00741936

An Effectiveness and Safety Study of Chinese Herbal Medicine for Functional Constipation

A Phase 2 study testing MaZiRenWan (MZRW) in people with Functional Gastrointestinal Disorders and Constipation, run by Hong Kong Baptist University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Functional constipation (FC) is a common complaint in clinical practice, but treatment for this condition in conventional medicine is suboptimal. Complementary and alternative medicines, especially Chinese herbal medicine (CHM) are used frequently by patients, however, there is little research evidence about these… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
MaZiRenWan (MZRW)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteChina
Study dates
Jul 2008to Dec 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meet of Rome III diagnostic criteria of functional constipation
  • Meet the diagnosis of Excessive Constipation according to the TCM theory
  • Age of 18 to 65 years (inclusive)
  • Complete spontaneous bowel movement (CSBM)≦2times/wk
  • Severity of constipation≧4pts (7 pts scale from 0 to 6pts) and the overall scoring of constipation-related symptoms≧8pts (6items in 7pts scale) for self symptom assessment in the run-in period
  • Normal colonic evaluation (colonoscopy or barium enema) within 5 years
  • Normal liver and renal function in blood test within 3 months

Who cannot join

  • Drug-induced constipation
  • Secondary causes of constipation (i.e. medical history of diabetes mellitus and thyroid disease)
  • Abdominal surgery (i.e. Caesarean operation)
  • Severe disease (i.e. cancer and acute present asthma)
  • Allergy to CHM (i.e. G6PD deficiency)
  • Pregnancy or breast-feeding
  • Psychiatric or addictive disorders

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hong Kong Baptist University Mr. & Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre

    Hong Kong

Other trials in China

About this study

Official title: Chinese Herbal Medicine for Functional Constipation: A Randomized, Double-blind, Placebo Controlled Trial

Functional constipation (FC) is a common complaint in clinical practice, but treatment for this condition in conventional medicine is suboptimal. Complementary and alternative medicines, especially Chinese herbal medicine (CHM) are used frequently by patients, however, there is little research evidence about these commonly used CHM. The purpose of the study is evaluate the efficacy and safety of an ancient CHM formula, MaZiRenWan (MZRW), by comparing with placebo.

Read the detailed description

Constipation is a common gastrointestinal complaint in clinical practice, which affects in estimated 12%-19% of American, 14% of Asian, and up to 27% of the population depending on demographic factor, sampling, and definition. With the unsatisfactory response to current symptomatic treatments, many patients seek help from traditional Chinese medicine (TCM), mostly by taking Chinese herbal medicine (CHM).

According to the TCM theory, constipation can be broadly divided into two types, excessive and deficient, based on the underlying aetiology. The former is characterized by the presence of Heat or pathological accumulation of Qi. Heat causes constipation by drying the Intestines and the stool. Patients present with hard, dry, pellet like stool, red complexion, dry mouth or halitosis, red tongue with a dry yellow coat, and slippery and rapid pulse. Qi stagnation causes constipation by disrupting the normal movement and descent of Stomach and Intestinal Qi. Patients present difficulty in passing stools, feelings of incomplete evacuation, abdominal distension or pain, frequent belching and flatulence, tongue with thin coat and wiry pulse. The latter, deficient constipation, is delineated as the dryness from insufficient fluid lubrication in the form of blood or lack of propulsion power from the deficiency of Qi or Yang. Besides, the treatment approaches vary from syndrome to syndrome.

The formula of MaZiRenWan (MZRW) composed of six Chinese herbs is firstly recorded in a TCM classic, Discussion of Cold-induced Disorders (Shang Han Lun), and it has been commonly used for constipation in excessive pattern throughout Asia since the Han Dynasty (A.D. 200). By combining the actions of these herbs, MZRW can moisten the Intestines, drain heat, promote the movement of Qi and unblock the bowel. Although previous studies show that MZRW has purgative and laxative effects and may be useful for functional constipation (FC), there are significant methodological weaknesses. Furthermore, the dose of CHM intervention being investigated from the first randomized controlled trial (RCT) published in 1983 is always based on the practitioner's experience, TCM literatures, or experts' comments, but not the results from stringent clinical trials, such as dose determination study. Therefore, the evidence produced will be attenuated or even misleading if improper dose is taken.

In the present study, the efficacy and safety of MZRW in optimal dosage were justified by comparing with placebo under strict clinical trial design.

Being tested
MaZiRenWan (MZRW), Placebo
Keywords
Functional Constipation, Chinese Herbal Medicine, MaZiRenWan, Hemp Seed Pill, Traditional Chinese Medicine, Herbal Medicine
Medical subject headings
Gastrointestinal Diseases, Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MaZiRenWan (MZRW)Drug

    Also called Hemp Seed Pill

    MZRW granule dissolved in 150ml hot water (oral), 7.5g/sachet, twice daily

  • PlaceboDrug

    Also called MZRW Placebo

    Placebo granule dissolved in 150ml hot water (oral), 7.5g/sachet, twice daily

Study groups in NCT00741936
Study groupRoleWhat they receive
MaZiRenWan (MZRW)ExperimentalMZRW granule, 7.5g/sachet
Receives: Drug: MaZiRenWan (MZRW)
PlaceboPlacebo comparatorPlacebo granule, 7.5g/sachet
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Responder of Complete Spontaneous Bowel Movement (CSBM)

    Patients with a mean increase of ≧1 complete spontaneous bowel movement(CSBM)/wk compared with the baseline(wk1-2) will be defined as responders. CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.

    Measured: End of treatment (wk10)

Secondary outcomes (10)

  1. Responder of Complete Spontaneous Bowel Movement (CSBM)

    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.

    CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.

    Measured: End of follow up (wk18)

  2. Bowel Movement

    Measured: Baseline(Wk1&2), Within treatment(Wk3-10) & Within follow-up(Wk11-18)

  3. Complete Spontaneous Bowel Movement (CSBM)

    Measured: Baseline(Wk1&2), Within treatment(Wk3-10), Within follow-up(Wk11-18)

  4. Changes on Individual Symptom Scores

    It was a 7-point ordinal scale from 0=not at all to 6=very severe.

    Measured: Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18)

  5. Global Symptoms Improvement

    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.

    Measured: Wk 6, 10 & wk 18

  6. Success of Blinding

    The success of blinding was evaluated for both investigator and patients as to whether MZRW or placebo had been taken.

    Measured: End of follow-up (Wk18)

  7. Blood Urea Level

    Measured: Pre-treatment (Wk2) & Post-treatment (Wk10)

  8. Blood Creatinine Level

    Measured: Pre-treatment (Wk2) & Post-treatment (Wk10)

  9. Serum Glutamic Pyruvic Transaminase(SGPT) Level

    Measured: Pre-treatment (Wk2) & Post-treatment (Wk10)

  10. Serum Glutamic Oxaloacetic Transaminase (SGOT)

    Measured: Pre-treatment (Wk2) & Post-treatment (Wk10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionNov 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00741936
Sponsor's protocol ID
PID-002
Status last verified
Mar 2015
First submitted
25 Aug 2008
Last updated
24 Jun 2016
Data monitoring committee
Yes

Publications

  • Cheng CW, Bian ZX, Zhu LX, Wu JC, Sung JJ. Efficacy of a Chinese herbal proprietary medicine (Hemp Seed Pill) for functional constipation. Am J Gastroenterol. 2011 Jan;106(1):120-9. doi: 10.1038/ajg.2010.305. Epub 2010 Nov 2.

    PubMed 21045817

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MaZiRenWan (MZRW) in people with Functional Gastrointestinal Disorders and Constipation, run by Hong Kong Baptist University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder of Complete Spontaneous Bowel Movement (CSBM) (time frame: End of treatment (wk10)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00741936, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.

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