The Study of Clinical Efficacy and Safety of Benjakul Remedy in Stage 4 Non Small Cell Lung Cancer

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20150805001
• Date of registration: 05/08/2015
• Prospective Registration: No
• Primary sponsor: National research council of thailand
• Public title: The Study of Clinical Efficacy and Safety of Benjakul Remedy in Stage 4 Non Small Cell Lung Cancer
• Scientific title: The Study of Clinical Efficacy and Safety of Benjakul Remedy in Stage 4 Non Small Cell Lung Cancer
• Date of first enrolment: 01/09/2014
• Target sample size: 16
• Recruitment status: Recruiting
• URL: https://www.thaiclinicaltrials.org/show/TCTR20150805001
• Study type: Interventional
• Study design: N/A
• Phase: Phase 2

Countries of recruitment

thailand

Contacts

• Name: Arunporn Itharat
• Affiliation: Faculty of medicine

• Name: Hataiwan Ratanabunjerdkul
• Affiliation: Faculty of medicine

Key inclusion & exclusion criteria

Inclusion criteria: 1. Females and males aged 25-70 years
2. Diagnosed with non-small cell lung cancer stage 4, confirmed by pathology and radiology
3. Do not respond to chemotherapy at least two formulas and can not be treated with drugs targetted.
4. Have never used herbs in the treatment of non-small cell lung cancer.
5. ECOG (Eastern Cooperative Oncology Group) performance status performance patients based on a scale of 0 to 2A
6. The following laboratory criteria
6.1 Hemoglobin ≥ 10 grams per deciliter
6.2 Leukocytes ≥ 3.0 x 109 / L
6.3 Lymphocyte Type of neutrophils > 1.5 x 109 / L
6.4 Platelet > 75 x 109 / L
6.5 Aspartate transferase (AST), alanine aminotransferase (ALT), alkaline phosphatase(ALP), bilirubin no more than 3 times that of standard
6.6 Creatinine no more than 1.5 mg per deciliter
7. Patients treated and followed up on schedule.
8. Volunteers must make a conscious decision to participate in the research themselves.
9. Patient understands and signs consent to participate in research.

Exclusion criteria: 1. ECOG Performance status in range the 3 to 5
2. The disease has spread to the brain
3. Has herbal drug allergy
4. Are pregnant or breastfeeding
5. Taking chemotherapy or other herbs during the study
6. Take medicine regularly for peptic ulcer
7. People who have problems swallowing who can not eat the capsule
8. Are participating in other research programs


Age minimum: 25 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diagnosed with non-small cell lung cancer stage 4, confirmed by pathology and radiology and do not respond to chemotherapy at least two formulas and can not be treated with drugs targetted
Carcinoma, Non-Small-Cell Lung [C04.588.894.797.520.109.220.249]

Carcinoma, Non-Small-Cell Lung [C04.588.894.797.520.109.220.249]

Intervention(s)

Benjakul recipe

Benjakul recipe capsule at dose of 100 mg. Take 2 capsules 3 times a day (600 mg /day) is for 24 weeks

Experimental Drug

Primary Outcome(s)

progression free survival ,time to tumor progression 8 month Radiology test

Secondary Outcome(s)

quality of life 8 month Thai-Modified Function Living Index Cancer Questionnaire (T-FLIC version 2 )

Source(s) of Monetary Support

National research council of thailand

Secondary Sponsor(s)

Assoc.Prof.Dr. Arunporn Itharat

Ethics review

Status: Submitted, approved
Approval date:
Contact:

The Study of Clinical Efficacy and Safety of Benjakul Remedy in Stage 4 Non Small Cell Lung Cancer

Results

• Date Completed: 01/06/2016