Phase 2
N=97
A Dose Determination Study of Chinese Herbal Medicine for Functional Constipation
Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00299975 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Responder for Complete Spontaneous Bowel Movement (CSBM) — 10; 14; 17; 22 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MaZiRenWan (MZRW) Low dose (Drug); MaZiRenWan (MZRW) Median dose (Drug); MaZiRenWan (MZRW) High dose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hong Kong Baptist University
- Primary completion
- Aug 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder for Complete Spontaneous Bowel Movement (CSBM) |
9; 10; 11; 23; 22; 21 | <0.05 sig |
| SECONDARY Responder for Complete Spontaneous Bowel Movement (CSBM) |
9; 10; 11; 23; 22; 21 | <0.05 sig |
| SECONDARY Bowel Movement |
3.6; 3.1; 4.7; 4.2; 4.8; 6.5 | <0.05 sig |
| SECONDARY Complete Spontaneous Bowel Movement (CSBM) |
0.5; 0.5; 0.5; 1.4; 1.6; 2.0 | <0.05 sig |
| SECONDARY Global Symptoms Improvement |
25; 24; 26; 4; 7; 4 | <0.05 sig |
| SECONDARY Severity of Constipation |
4.22; 4.06; 4.25; 2.72; 2.03; 2.03 | <0.05 sig |
| SECONDARY Sensation of Straining |
4.03; 3.53; 3.78; 2.62; 1.84; 2.16 | <0.05 sig |
| SECONDARY Incomplete of Evacuation |
4.53; 3.5; 3.97; 2.81; 2.59; 2.59 | <0.05 sig |
| SECONDARY Sensation of Bloating |
2.53; 2.75; 3.28; 2.03; 1.84; 1.91 | <0.05 sig |
| SECONDARY Sensation of Abdominal Pain/Cramping |
1.00; 1.12; 1.59; 1.00; 1.03; 1.50 | <0.05 sig |
| SECONDARY Passing of Gas |
2.37; 2.59; 3.34; 2.03; 1.97; 2.44 | <0.05 sig |
| SECONDARY Adverse Effects (e.g. Renal and Liver Function Tests) |
— | — |
| SECONDARY Blood Urea Level |
4.68; 4.54; 4.31; 4.40; 4.41; 4.30 | <0.05 sig |
| SECONDARY Blood Creatinine Level |
58.81; 58.00; 57.38; 58.81; 60.06; 58.09 | <0.05 sig |
| SECONDARY Serum Glutamic Pyruvic Transaminase(SGPT) Level |
32.38; 32.78; 34.06; 33.44; 34.06; 34.16 | <0.05 sig |
| SECONDARY Serum Glutamic Oxaloacetic Transaminase(SGOT) Level |
18.50; 18.28; 19.44; 18.69; 19.09; 19.09 | <0.05 sig |
Summary
Functional constipation (FC) is common with 14.3% estimated prevalence in Hong Kong, but treatment for this condition in conventional medicine is suboptimal. Complementary and alternative medicines, especially Chinese herbal medicine (CHM) are used frequently by patients with FC, but there is little research evidence about these commonly used CHM. The purpose of the study is evaluate the efficacy and safety of CHM, as well as determining the optimal dosage.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of functional constipation with Rome II criteria
- General stool type belongs to Type 1 to 4 according to Bristol Stool Form Scale
- Complete spontaneous bowel movement≦2 movements per week
Exclusion Criteria
- Anti-diarrhoeal therapy
- Drug-induced constipation
- Medical history of important bowel pathology, such as inflammatory bowel disease, congenital or acquired megacolon / megarectum
- Medical history of previous abdominal surgery
- Taking chronic medications that contain any kind of herbs, mineral, or specific vitamin supplements
- Medical history of carbohydrate malabsorption, hormonal disorder, cancer, diabetes mellitus, hypothyroidism, asthma, renal impairment and/or any other serious diseases
- History of laxative abuse
- History of allergy to Chinese herbal medicine
- Psychiatric or addictive disorders
- Pregnancy or breast-feeding
- Any other serious diseases
Data sourced from ClinicalTrials.gov (NCT00299975). 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.