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| Name | Class |
|---|---|
| Queen Elizabeth Hospital, Hong Kong | OTHER |
| Prince of Wales Hospital, Shatin, Hong Kong | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MZRW | Experimental | 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). |
|
| Senna | Active Comparator | Senna is a stimulant laxative which facilitates the passage of stools by altering intestinal electrolyte transport and increasing intestinal motor activity. |
|
| Placebo | Placebo Comparator | Placebo MZRW and Placebo Senna |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the responder rate for CSBM during the treatment period | 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 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the responder rate for CSBM during the follow-up period | 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 | 8 weeks |
| Individual assessment of constipation and related symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhao Xiang Bian, MD, Ph. D | School of Chinese Medicine, Hong Kong Baptist University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Chinese Medicine, Hong Kong Baptist University | Hong Kong | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29654915 | Derived | Zhong LLD, Cheng CW, Kun W, Dai L, Hu DD, Ning ZW, Xiao HT, Lin CY, Zhao L, Huang T, Tian K, Chan KH, Lam TW, Chen XR, Wong CT, Li M, Lu AP, Wu JCY, Bian ZX. Efficacy of MaZiRenWan, a Chinese Herbal Medicine, in Patients With Functional Constipation in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2019 Jun;17(7):1303-1310.e18. doi: 10.1016/j.cgh.2018.04.005. Epub 2018 Apr 12. | |
| 24180235 |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000081226 | Sennosides |
| ID | Term |
|---|---|
| D012676 | Senna Extract |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
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| Senna | Drug | Patients are instructed to take 2 tablets at the bedtime for 8 weeks. |
|
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| 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. |
|
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 |
| 18 weeks |
| the changes of colonic transit time | 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. | 18 weeks |
| Global symptom assessment | 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. | 18 weeks |
| Success of blinding | the success of blinding is evaluated for both investigator and patients as to whether CHM, WM or placebo had been taken | 18 weeks |
| safety profiles | Assessed by determining the important adverse events reported in the participants ' diaries, follow-up interviews,and clinical laboratory evaluationse.g., liver and renal function. | 18 weeks |
| Derived |
| Zhong LL, Cheng CW, Chan Y, Chan KH, Lam TW, Chen XR, Wong CT, Wu JC, Bian ZX. Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial. Trials. 2013 Nov 4;14:366. doi: 10.1186/1745-6215-14-366. |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |