Phase 2
N=120
An Effectiveness and Safety Study of Chinese Herbal Medicine for Functional Constipation
Functional Gastrointestinal Disorders · Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00741936 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Responder of Complete Spontaneous Bowel Movement (CSBM) — 26; 5; 34; 55 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MaZiRenWan (MZRW) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hong Kong Baptist University
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder of Complete Spontaneous Bowel Movement (CSBM) |
26; 5; 34; 55 | <0.05 sig |
| SECONDARY Responder of Complete Spontaneous Bowel Movement (CSBM) |
26; 5; 34; 55 | <0.05 sig |
| SECONDARY Bowel Movement |
2.79; 3.31; 4.72; 3.73; 3.65; 3.61 | <0.05 sig |
| SECONDARY Complete Spontaneous Bowel Movement (CSBM) |
0.33; 0.52; 1.62; 0.72; 1.06; 0.75 | <0.05 sig |
| SECONDARY Changes on Individual Symptom Scores |
4.47; 4.40; 2.82; 3.70; 2.93; 3.47 | <0.05 sig |
| SECONDARY Global Symptoms Improvement |
49; 28; 11; 27; 0; 5 | <0.05 sig |
| SECONDARY Success of Blinding |
32; 16; 42; 27 | — |
| SECONDARY Blood Urea Level |
3.87; 3.98; 4.01; 4.24 | <0.05 sig |
| SECONDARY Blood Creatinine Level |
66.67; 66.05; 66.90; 64.62 | <0.05 sig |
| SECONDARY Serum Glutamic Pyruvic Transaminase(SGPT) Level |
15.82; 14.05; 14.70; 13.68 | <0.05 sig |
| SECONDARY Serum Glutamic Oxaloacetic Transaminase (SGOT) |
17.82; 17.77; 17.20; 17.12 | <0.05 sig |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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
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 disease (i.e. cancer and acute present asthma)
- Allergy to CHM (i.e. G6PD deficiency)
- Pregnancy or breast-feeding
- Psychiatric or addictive disorders
Data sourced from ClinicalTrials.gov (NCT00741936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.