NCT04475276CompletedPhase 4
Effect of Alpha Lipoic Acid on Non-alcoholic Fatty Liver Diseases
Effect of Alpha Lipoic Acid on Non-alcoholic Fatty Liver Diseases: A Randomized Placebo-controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 14 Aug 2025
Brief summary (registry, in English)
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 -20%).Till date, there is no US-FDA approved therapy for NAFLD but drugs like metformin, pioglitazone, sitagliptin, vildagliptin Vitamin E, silymarin, statins and ezetimibe have been studied along with life style modification. Life style modifications is the current modality of treatment of NAFLD. All the above-mentioned drugs have some beneficial effects with limited use due to its adverse effects in patients of NAFLD and the study results are non-conclusive. In this scenario, a safe hepatoprotective drug to be evaluated in NAFLD.Alpha-lipoic acid (ALA) or 6,8-thioctic acid, is an endogenous molecule which functions as an important co-factor for various enzyme complexes in mitochondria and plays an important role in energy metabolism. ALA is a nutraceutical agent which also has hepatoprotective and anti-inflammatory effects.ALA is a nutraceutic having anti-inflammatory and antioxidant effects and also increasing insulin sensitivity with lesser adverse effects. The relative scarcity of a promising therapy and non-conclusiveness of the previous studies open up an arena of further research using a nutraceutic in non-diabetic NAFLD. So, the present study is designed to evaluate safety and efficacy of ALA in non-diabetic NAFLD patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 10 Jul 2020
- Start date
- 23 Feb 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04475276
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 120
- From 23 Feb 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drug abusers and Alcoholics.
- Drug users such as corticosteroids, antiviral (nucleoside analogue), tetracycline, methotrexate, tamoxifen and amiodarone.
Other illness
- History of diabetes mellitus, decompensated liver disease, ascites, oesophageal varices.
- 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.
Other
- Patients who are taking any antihyperlipidemic and anti-diabetic agents.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AIIMS Coordinator of this site? Confirm its status | Bhubaneswar | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.