Efficacy and Safety of Thai Herbal Formularies Benja Amarit in Hepatocellular Carcinoma Patients: Clinical Trial Phase II
Study ID: TCTR20170621002
Current status: Pending (Not yet recruiting)
Last Updated: June 20, 2017
Tracking Information
Date of Registration in Primary Registry: June 20, 2017
Date of First Enrollment: July 01, 2017 (Anticipated)
Target Sample Size: 81
Last Updated Date: June 20, 2017
Primary Outcome(s):
  • Outcome name: Overall survival
       Metric/method of measurement: Duration of survival
       Time point: day 0 28 56 84 112 140
       Safety Issue?: Yes


  • Key Secondary Outcomes:
  • Outcome name: RECIST Criteria
       Metric/method of measurement: state of RECIST Criteria
       Time point: day 28 112
       Safety Issue?: No


  • Outcome name: Quality of life
       Metric/method of measurement: Thai Modified Function Living Index Cancer Questionnaire Version 2
       Time point: day 0 28 56 84 112 140
       Safety Issue?: No


  • Outcome name: safety
       Metric/method of measurement: Number of adverse drug event
       Time point: day 0 28 56 84 112 140
       Safety Issue?: Yes


  • Descriptive Information
    Public Title: Efficacy and Safety of Thai Herbal Formularies Benja Amarit in Hepatocellular Carcinoma Patients: Clinical Trial Phase II
    Scientific Title: Efficacy and Safety of Thai Herbal Formularies Benja Amarit in Hepatocellular Carcinoma Patients: Clinical Trial Phase II
    Brief Summary:
    Detailed Description:
    Study Design: Allocation: Randomized controlled trial
    Control: Placebo
    Study Endpoint Classification: Safety/Efficacy Study
    Intervention Model: Parallel
    Number of Arms: 2
    Masking: Double Blind (Masked Roles: Subject, Investigator)
    Primary Purpose: Treatment
    Study Phase: Phase 2
    Health Condition(s) or Problem(s) Studied: This study to explore effficacy and safty of Thai herbal formularies Benja Amarit in hapatocellular carcinoma (Clinical trail phase II). , Study in hepatocellular carcinoma patient, Child-Pugh score A
    Study Arms:
  • Arm: 1
  • Intervention Name: Thai Herbal Formularies Benja Amarit
    Type: Experimental
    Classification: Drug
    Descriptions: Active ingredientThai in Herbal Formularies Benja Amarit:
    1. Piper retrofractum Vahl.
    2. Zingiber officinale Roscoe.
    3. Piper nigrum L.
    4. Citrus hystrix DC.
    5. Baliospermum montanum (Willd.) Muell. Arg.
    6. Ferula assafoetida Linn.
    7. Garcinia hanburyi Hook.f.
    8. Magnesium sulfate
    9. Aloe ferox extract
  • Arm: 2
  • Intervention Name: placebo
    Type: Placebo Comparator
    Classification: No treatment
    Descriptions: Placebo make form excipient. Color and odor are same active drug.
    Recruitment Information
    Recruitment Status: Pending (Not yet recruiting)
    Estimated Enrollment: 81
    Study Start Date (First enrollment): July 01, 2017
    Primary Completion Date: July 01, 2018
    Inclusion Criteria:
    Inclusion Criteria
    Gender: Both
    Age Limit: Minimum 18 Years : Maximum 80 Years
    1 Patients who have been diagnosed is Hepatocellular carcinoma Child Pugh score class A OR B
    2 Patients who cannot treat by standard treatment
    3 Stop another treatment not less than 4 weeks
    4 Stop radiation and chemotherapy not less than 4 weeks
    5 Thai age between 18 80 years
    6 Zubrod ECOG WHO score between 0 2
    7 Patients who was evaluated to survival more than 5 months
    8
    To understand Thai language and to communicate with research assistants to assess side effects from treatment
    Can receive medication and follow up as prescribed
    Consent and sign the name in research
    Exclusion Criteria
    1 Patients who have been allergy to ingredient of formularies Benja Amarit
    2 Pregnant or breastfeeding women
    3 Receive chemotherapy or use herb or vitamin its out of standard treatment
    4 Patient who have acute illness such as sepsis
    Accept Healthy Volunteers: No
    Countries of Recruitment Thailand
    Contact for Public Queries:
    Contact for Public Query's Name: Monthaka - Teerachaisakul
    Degree: PhD
    Phone: 02-224-3265        Ext: -
    Email: monthaka.t@gmail.com
    Postal Address: Thai Traditional Medicine Research Institute
    State/Province: Bangkok        Postal Code: 10100
    Country: Thailand
    Administrative Information
    Primary Registry Site: Thai Clinical Trials Registry
    Trial Identification Number: TCTR20170621002
    Secondary Identifying Numbers: Nil known
    Source(s) of Monetary or Material Supports: Department of Thai Traditional and Alternative Medicine
    Study Primary Sponsor: Department of Thai Traditional and Alternative Medicine
    Study Secondary Sponsor: 1.) non
    Contact for Scientific Queries:
    Contact for Scientific Query's Name: Monthaka - Teerachaisakul
    Degree: PhD
    Phone: 02-224-3265        Ext: -
    Email: monthaka.t@gmail.com
    Postal Address: 693 Thai Traditional Medicine Research Institute
    State/Province: Bangkok        Postal Code: 10100
    Country: Thailand
    Track changes

    Copyright  © 2009. Medical Research Foundation, Thailand. All Rights Reserved.