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| Name | Class |
|---|---|
| Food and Health Bureau, Hong Kong | OTHER_GOV |
| Purapharm International (Hk) Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MaZiRenWan (MZRW) | Experimental | MZRW granule, 7.5g/sachet |
|
| Placebo | Placebo Comparator | Placebo granule, 7.5g/sachet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MaZiRenWan (MZRW) | Drug | MZRW granule dissolved in 150ml hot water (oral), 7.5g/sachet, twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of treatment (wk10) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhao-xiang Bian, PhD | Hong Kong Baptist University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Baptist University Mr. & Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21045817 | Result | 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. |
| Label | URL |
|---|---|
| Abstract | View source |
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Many patients were excluded because they did not fulfill the inclusion criteria or they met the exclusion criteria. The demographic data and baseline variables of participants were comparable among groups
All constipated patients (aged 18-65 years) who presented to the Chinese medicine clinics of the School of Chinese Medicine, Hong Kong Baptist University were referred. In total, 456 patients with constipation were screened from July 2008 to September 2009; of these 120 were randomized into MZRW or placebo group.
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| ID | Title | Description |
|---|---|---|
| FG000 | MaZiRenWan (MZRW) | MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. |
| FG001 | Placebo | Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MaZiRenWan (MZRW) | MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Number | participants | End of follow up (wk18) |
|
Within the whole 18 weeks study period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MaZiRenWan (MZRW) | MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain / cramping or bloating | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Zhao-xiang Bian | Hong Kong Baptist University | (852) 3411 2905 | bzxiang@hkbu.edu.hk |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591093 | ma zi ren wan |
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| Placebo | Drug | Placebo granule dissolved in 150ml hot water (oral), 7.5g/sachet, twice daily |
|
|
| End of follow up (wk18) |
| Bowel Movement | Baseline(Wk1&2), Within treatment(Wk3-10) & Within follow-up(Wk11-18) |
| Complete Spontaneous Bowel Movement (CSBM) | Baseline(Wk1&2), Within treatment(Wk3-10), Within follow-up(Wk11-18) |
| Changes on Individual Symptom Scores | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18) |
| 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. | Wk 6, 10 & wk 18 |
| Success of Blinding | The success of blinding was evaluated for both investigator and patients as to whether MZRW or placebo had been taken. | End of follow-up (Wk18) |
| Blood Urea Level | Pre-treatment (Wk2) & Post-treatment (Wk10) |
| Blood Creatinine Level | Pre-treatment (Wk2) & Post-treatment (Wk10) |
| Serum Glutamic Pyruvic Transaminase(SGPT) Level | Pre-treatment (Wk2) & Post-treatment (Wk10) |
| Serum Glutamic Oxaloacetic Transaminase (SGOT) | Pre-treatment (Wk2) & Post-treatment (Wk10) |
| Pregnancy |
|
| Protocol Violation |
|
| Lack of Efficacy |
|
| Low compliance |
|
Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Duration of constipation | Mean | Standard Deviation | years |
|
| Bowel movement | Mean | Standard Deviation | movements per week |
|
| Complete spontaneous bowel movement (CSBM) | 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. | Mean | Standard Deviation | movements per week |
|
| No. of days taking rescue therapy | Mean | Standard Deviation | days per week |
|
| Severity of constipation | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Mean | Standard Deviation | Units on a scale |
|
| OG001 | Placebo | Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. |
|
|
|
| Secondary | Bowel Movement | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | movements per week | Baseline(Wk1&2), Within treatment(Wk3-10) & Within follow-up(Wk11-18) |
|
|
|
|
| Secondary | Complete Spontaneous Bowel Movement (CSBM) | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | movements per week | Baseline(Wk1&2), Within treatment(Wk3-10), Within follow-up(Wk11-18) |
|
|
|
|
| Secondary | Changes on Individual Symptom Scores | It was a 7-point ordinal scale from 0=not at all to 6=very severe. | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | Units on a scale | Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18) |
|
|
|
|
| Secondary | 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. | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Number | participants | Wk 6, 10 & wk 18 |
|
|
|
|
| Secondary | Success of Blinding | The success of blinding was evaluated for both investigator and patients as to whether MZRW or placebo had been taken. | Only for subjects attended the last follow-up visit on Wk 18. | Posted | Number | participants | End of follow-up (Wk18) | No. of subjects attended last visit | Participants |
|
|
|
|
| Primary | 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. | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Number | participants | End of treatment (wk10) |
|
|
|
|
| Secondary | Blood Urea Level | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | mmol/L | Pre-treatment (Wk2) & Post-treatment (Wk10) |
|
|
|
|
| Secondary | Blood Creatinine Level | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | μmol/L | Pre-treatment (Wk2) & Post-treatment (Wk10) |
|
|
|
|
| Secondary | Serum Glutamic Pyruvic Transaminase(SGPT) Level | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | U/L | Pre-treatment (Wk2) & Post-treatment (Wk10) |
|
|
|
|
| Secondary | Serum Glutamic Oxaloacetic Transaminase (SGOT) | Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward. | Posted | Mean | Standard Deviation | U/L | Pre-treatment (Wk2) & Post-treatment (Wk10) |
|
|
|
|
| 0 |
| 60 |
| 11 |
| 60 |
| EG001 | Placebo | Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks. | 0 | 60 | 7 | 60 |
| nausea or stomach discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| diarrhea and passing of gas | Gastrointestinal disorders | Systematic Assessment |
|
| dizziness or headache | General disorders | Non-systematic Assessment |
|
| palpitations and trembling hands | General disorders | Non-systematic Assessment |
|
| difficulty in micturition | Renal and urinary disorders | Non-systematic Assessment | Subject with a history of hyperplastic prostate |
|
| aggravation of rhinitis symptoms | General disorders | Non-systematic Assessment | Subject with history of rhinitis. |
|
| skin itching | General disorders | Non-systematic Assessment |
|
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| Within follow-up(Wk11-18) |
|
| Within follow-up (Wk11-18) |
|
| Severity of constipation (Wk10) |
|
| Severity of constipation (Wk18) |
|
| Sensation of straining (Baseline) |
|
| Sensation of straining (Wk6) |
|
| Sensation of straining (Wk10) |
|
| Sensation of straining (Wk18) |
|
| Incomplete of evacuation (Baseline) |
|
| Incomplete of evacuation (Wk6) |
|
| Incomplete of evacuation (Wk10) |
|
| Incomplete of evacuation (Wk18) |
|
| Sensation of bloating (Baseline) |
|
| Sensation of bloating (Wk6) |
|
| Sensation of bloating (Wk10) |
|
| Sensation of bloating (Wk18) |
|
| Sensation of abdominal pain/cramping (Baseline) |
|
| Sensation of abdominal pain/cramping (Wk6) |
|
| Sensation of abdominal pain/cramping (Wk10) |
|
| Sensation of abdominal pain/cramping (Wk18) |
|
| Sensation of nausea (Baseline) |
|
| Sensation of nausea (Wk6) |
|
| Sensation of nausea (Wk10) |
|
| Sensation of nausea (Wk18) |
|
| Passing of gas (Baseline) |
|
| Passing of gas (Wk6) |
|
| Passing of gas (Wk10) |
|
| Passing of gas (Wk18) |
|
| Worse (Wk6) |
|
| Improved (Wk10) |
|
| Same (Wk10) |
|
| Worse (Wk10) |
|
| Improved (Wk18) |
|
| Same (Wk18) |
|
| Worse (Wk18) |
|