Constipation
Conditions
Keywords
Chinese herbal medicine formula, MaZiRenWan, Randomized controlled trial, Constipation, Palliative care in cancer
Brief summary
It is a double-blinded, randomized, placebo-controlled trial for advanced cancer patients with constipation. 60 patients will be randomly assigned to have individualized herbal intervention (treatment group) or placebo (control group) in 1:1 ratio. For the treatment group, MaZiRenWan 10g plus HuangQi 20g are chosen as the core prescription. Furthermore, six herbal granules can be added according to the syndrome differentiated for individual participant. Placebo 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 the herbal granules. Patients are instructed to dissolve the granules in 150ml of hot water, twice daily for two weeks. The primary end point is the global symptom improvement. Secondary outcome measures include stool frequency, stool form, use of rescue herbal granules, constipation visual analogue scale (CVAS) (0=none to 7=most severe) and individual assessment of constipation related symptoms. For the safety profiles of herbal intervention, the important adverse events reported and clinical laboratory evaluations of liver and renal function are determined.
Interventions
DRUGPlacebo
Sponsors
Caritas Medical Centre, Hong Kong
Yan Chai Hospital
Our Lady of Maryknoll Hospital
Hong Kong Buddhist Hospital
Hospital Authority, Hong Kong
Hong Kong Baptist University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Severity of constipation \> 3 points (an 8-point scale from 0 to 7) * Palliative Performance Scale ≥60% * Relatively stable liver and renal function within 3 months * Patients who can read and speak Chinese
Exclusion criteria
* Inability to communicate * Presence of a colostomy, or gastrointestinal obstruction * Presence of loose or watery stool (Bristol stool scale 6-7) or bowel movement \> 3/day under routine laxative treatment * History of Chinese herbal medicine allergies * Estimated life expectancy less than 1 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global symptom improvement (improved / same / worse) | 2 weeks | Participants are asked to rate their impression of change in constipation symptoms in comparison with their baseline, with scores from 0 to 6 represents markedly worse or better at the respective extremes. The response categories are collapsed to simply improved for score 4-6, same for score 3, or worse for score 0-2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool form | 2 weeks | Stool form is assessed with 7-point Bristol Stool Scale (ranging from separate hard lumps to watery) |
| Extra laxatives used (times/week) | 2 week | — |
| Constipation visual analogue scale | 2 weeks | The severity of constipation is evaluated by an eight point ordinal rating scale (0=none to 7=most severe) |
| Constipation related symptoms | 2 weeks | Sensation of straining, incomplete evacuation, bloating, abdominal pain/cramping, nausea, and passing of gas are recorded using a 7-point ordinal scale (0=not at all and 6=very severe) |
| Number of bowel movement (times/day) | 2 weeks | — |
| Blood creatinine level (umol/L) | 2 weeks | — |
| Blood urea level (mmol/L) | 2 weeks | — |
| Serum glutamic pyruvic transaminase(SGPT) Level (U/L) | 2 weeks | — |
| Serum Glutamic Oxaloacetic Transaminase (SGOT) Level (U/L) | 2 weeks | — |
| Adverse events | 2 weeks | — |
Countries
Hong Kong
Outcome results
None listed