CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04475276
NCT04475276Phase 4Completed

Effect of Alpha Lipoic Acid on Non-alcoholic Fatty Liver Diseases: A Randomized Placebo-controlled Clinical Trial

All India Institute of Medical Sciences, Bhubaneswar·interventional·Posted Jul 17, 2020·Updated Aug 14, 2025

In Brief

A Phase 4 clinical trial evaluating Placebo and Alphalipoic acid for Non-Alcoholic Fatty Liver Disease. Completed, enrolled 120 participants across 1 site.

Detailed 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 -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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJul 17, 2020
Enrollment StartFeb 23, 2021
Primary CompletionDec 31, 2023
Study CompletionJan 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.0 years ago

Interventions

Placebodrug

Lifestyle modification with placebo for 12 weeks

Alphalipoic aciddrug

Lifestyle modification with Alphalipoic acid for 12 weeks