Evaluating Alpha Lipoic Acid for Non-Alcoholic Fatty Liver Disease
Effect of Alpha Lipoic Acid on Non-alcoholic Fatty Liver Diseases: A Randomized Placebo-controlled Clinical Trial
This study is testing if Alpha Lipoic Acid can help people with Non-Alcoholic Fatty Liver Disease improve their liver health compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences, Bhubaneswar Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Bhubaneswar, Odisha) |
| Trial ID | NCT04475276 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Alpha Lipoic Acid (ALA) on patients diagnosed with Non-Alcoholic Fatty Liver Disease (NAFLD). The study aims to assess the hepatoprotective and anti-inflammatory properties of ALA, which has shown promise in previous animal studies. Participants will be treated with either ALA or a placebo, and their liver function will be monitored through serum aminotransferase levels and abdominal ultrasound. The trial focuses on treatment-naïve patients aged 18-65 with mild to moderate liver disease.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-65 with a diagnosis of fatty liver disease and mild to moderate elevation of liver enzymes.
Not a fit: Patients with a history of diabetes, decompensated liver disease, or those currently on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safe and effective option for managing Non-Alcoholic Fatty Liver Disease.
How similar studies have performed: Previous studies have shown positive results with similar nutraceutical approaches, but this specific application of ALA is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Bhubaneswar, Odisha
- Aiims — Bhubaneswar, Odisha, India (Recruiting)
Study contacts
- Study coordinator: Monalisa Jena, MD
- Email: drmonalisajena@gmail.com
- Phone: 9438884193
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.