Clinical Trial on Palliative Cancer Patients With Constipation
Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Hong Kong Baptist University
Collaborators:
Caritas Medical Centre Caritas Medical Centre, Hong Kong Hong Kong Buddhist Hospital Hospital Authority, Hong Kong Our Lady of Maryknoll Hospital Yan Chai Hospital