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Clinical Trial on Palliative Cancer Patients With Constipation

NCT02795390 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-08-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Chinese herbal medicine

DRUG

Placebo

Sponsors & Collaborators

  • Caritas Medical Centre, Hong Kong

    collaborator OTHER

  • Yan Chai Hospital

    collaborator OTHER

  • Our Lady of Maryknoll Hospital

    collaborator OTHER

  • Hong Kong Buddhist Hospital

    collaborator OTHER

  • Hospital Authority, Hong Kong

    collaborator OTHER_GOV

  • Hong Kong Baptist University

    lead OTHER

Principal Investigators

  • Zhao-xiang Bian, PhD · Hong Kong Baptist University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Hong Kong

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02795390 on ClinicalTrials.gov