Effect of Alpha Lipoic Acid on Non-alcoholic Fatty Liver Diseases
Status:
Recruiting
Trial end date:
2022-07-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar