Trial | NCT02795390  Report issue

Title

Clinical Trial on Palliative Cancer Patients With Constipation
Chinese and Western Medicine Collaborative Studies on Palliative Cancer Patients With Constipation

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    huangkui ...

  • Study Participants

    60
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.
Study Started
Nov 30
2016
Primary Completion
Aug 31
2018
Study Completion
Aug 31
2018
Last Update
Aug 08
2018

Drug Chinese herbal medicine

Drug Placebo

Chinese herbal medicine Experimental

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. They are ShuDiHuang 15g and Danggui 10g for deficiency of blood, Maidong 15g and ShengDiHuang 10g for deficiency of Yin, and RouCongRong 15g and Niuxi 10g for deficiency of Yang.

Placebo Placebo Comparator

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.

Criteria 

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
No Results Posted