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Efficacy and Safety of Thai Herbal Formularies Benja Amarit in Hepatocellular Carcinoma Patients: Clinical Trial Phase II

Phase 2
Conditions
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&#44
Child&#45
Pugh score A
Hepatocellular carcinoma&#44
Thai Herbal Formularies Benja Amarit&#44
Thai herbal
Registration Number
TCTR20170621002
Lead Sponsor
Department of Thai Traditional and Alternative Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending (Not yet recruiting)
Sex
All
Target Recruitment
81
Inclusion Criteria

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Overall survival day 0 28 56 84 112 140 Duration of survival
Secondary Outcome Measures
NameTimeMethod
RECIST Criteria day 28 112 state of RECIST Criteria,Quality of life day 0 28 56 84 112 140 Thai Modified Function Living Index Cancer Questionnaire Version 2,safety day 0 28 56 84 112 140 Number of adverse drug event
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