Functional Constipation, Gastrointestinal Disorders
Conditions
Keywords
Randomized controlled trial, Drugs,Chinese Herbal, Constipation/drug therapy
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.
Interventions
DRUGMZRW
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.
DRUGSenna
Patients are instructed to take 2 tablets at the bedtime for 8 weeks.
DRUGplacebo
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.
Sponsors
Queen Elizabeth Hospital, Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Hong Kong Baptist University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the responder rate for CSBM during the treatment period | 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
| Measure | Time frame | Description |
|---|---|---|
| Individual assessment of constipation and related symptoms | 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 | 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. |
| the responder rate for CSBM during the follow-up period | 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 |
| Success of blinding | 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 | 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. |
| Global symptom assessment | 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. |
Countries
China
Outcome results
None listed