Effect of a a novel curcumin-galactomannoside complex (CGM)delivery syste on Improvement of liver function markers in chronic alcoholic patients.
Not Applicable
Completed
- Registration Number
- CTRI/2018/03/012385
- Lead Sponsor
- Akay Flavours And Aromatics Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
1.Chronic alcohol intake of more than six units per week. 1 unit is equal to 150 ml of wine or 360 ml of beer or 45 ml of 40 percentage alcohol
2.Mild to moderate cases of alcoholic hepatitis
3.Ratio of AST to ALT greater than 2
4.Informed consent
Exclusion Criteria
1.Present with kidney failure (serum creatinine > 2.0 mg/dl) or in the process of renal dialysis
2.Present with Viral hepatitis (ALT level >/equal to 3 times the upper limit)
3.Receive any herbal medications or curcumin
4.Subjects abstaining from alcohol for
more than 1 month
5. concomitant symptomatic or asymptomatic bacterial
infection and severe bacterial infection
within the previous 3 months.
6.Pregnancy or breastfeeding
7.Have a history of gall bladder diseases or removal
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - reduction in liver enzymes <br/ ><br>- Changes in anti inflammatory markers <br/ ><br>- Changes in Antioxidant parametersTimepoint: Day 0, Day 56
- Secondary Outcome Measures
Name Time Method - Changes in Lipid Profile <br/ ><br>- Changes in Safety parameters/ Adverse eventsTimepoint: Day 0, Day 56