Status:
COMPLETED
Effect of Alpha Lipoic Acid on Non-alcoholic Fatty Liver Diseases
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
In developed counties Non-alcoholic fatty liver disease (NAFLD) becomes the most common cause of chronic liver disease , but its prevalence in developing countries like India is also increasing (10 -2...
Detailed Description
In developed counties Non-alcoholic fatty liver disease (NAFLD) becomes the most common cause of chronic liver disease , but its prevalence in developing countries like India is also increasing (10 -2...
Eligibility Criteria
Inclusion
- All patients diagnosed to have fatty liver grading 1, 2, 3 on abdominal ultrasound, mild to moderate elevation (\<5 times elevated upper limit) of serum aminotransferase level.
- Patients aged 18-65 years of either sex.
- Treatment naïve patients or patients who had not taken any treatment for at least 4 weeks before inclusion
Exclusion
- History of diabetes mellitus, decompensated liver disease, ascites, oesophageal varices.
- Drug abusers and Alcoholics.
- HBs Ag positive, Anti HCV and HIV, hereditary defects of iron, copper and alpha- 1 antitrypsin deficient patients.
- Hypothyroidism, obstructive sleep apnoea, total parenteral nutrition, short bowel syndrome, pancreatoduodenal resection which are secondary causes of NAFLD.
- Drug users such as corticosteroids, antiviral (nucleoside analogue), tetracycline, methotrexate, tamoxifen and amiodarone.
- Patients who are taking any antihyperlipidemic and anti-diabetic agents.
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04475276
Start Date
February 23 2021
End Date
January 1 2024
Last Update
August 14 2025
Active Locations (1)
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1
AIIMS
Bhubaneswar, Odisha, India, 751019