Health Condition 1: K769- Liver disease, unspecified
Conditions
Interventions
Intervention1: CAE50: CA has been reported to have hepatoprotective effects through increasing the levels of antioxidant enzymes and reducing the levels of inflammatory mediators
1 tablet per day, mor
Sponsors
GENECELL CO LTD
Eligibility
Inclusion criteria
Inclusion criteria: 01. Volunteers of either sex, between 20 to 70 years of age. 02. Volunteers with ALT level between 45U/L-135U/L. 03. Volunteers with AST level >=25U/L the last 2 weeks. 04. Volunteers having no clinically significant liver disorder, but clinically non-significant problem with accommodation of the liver can be included. 05. Able to abide the dietary regime mentioned in the protocol 06. Willing to come for regular followâ??up visits 07. Able to give written informed consent.
Exclusion criteria
Exclusion criteria: 01. Known history of hypersensitivity to herbal extracts or dietary supplements. 02. Volunteers having other liver disorder like hepatitis, liver cirrhosis, alcoholic liver disease, drug induced liver disease etc. was excluded. 03. Volunteers with ALT/AST/r-GT level exceed 3 times the normal upper limit. 04. Chronic alcoholic disease. - alcohol consumption >=30g/day(120g/week) 05. Volunteers having systemic diseases like hyper-cholesterolemia, renal disorder, diabetes mellitus, COPD and other debilitating diseases. 06. Volunteers with a history of cancer and intervention within 5 years prior to screening. 07. Volunteers having hepatobiliary disease or jaundice within 5 years prior to screening. 08. Pregnant women, lactating women. 09. Use of prescription drugs known to alter body weight or appetite within 4 weeks prior to screening. 10. Volunteers with clinically significant cardiovascular disease or intervention within 6 months prior to screening. 11. Volunteers with a history of alcohol abuse or drug abuse. 12. Volunteers having continuous consumption of oriental medicine, supplements, drugs that affect liver function within 4 weeks prior to screening. 13. History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing. 14. Any condition that in the opinion of the investigator does not justify the subjectâ??s inclusion for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in Hepatic function related markerTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| change in safety parameters at the EOTTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactSubham Dutta
Syncorp Clincare Technologies Pvt. Ltd.
Outcome results
None listed