NCT01650181

Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis

Biochemical and Echosonographic Impacts Using Siliphos-Selenium-Methionine-Alpha Lipoic Acid + Metformin Versus Metformin in Patients With Fatty Liver and Steatohepatitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Non-alcoholic steatohepatitis represents 10 - 15% total cases of hepatic cirrhosis. In the upcoming years, the economic burden of this disease will increase and will mean an important problem for our health system due to obesity epidemic. There are several treatments for non-alcoholic steatohepatitis; however, none of them have overcome a healthy lifestyle including diet, exercise and some drugs related with insulin metabolism. There after, using hepatoprotective drugs and antioxidants have been recommended as an eligible therapy to reduce the progression from fatty liver to steatohepatitis and cirrhosis. Being this approach not only an experimental item yet but also an unavoidable reality. The purpose of this randomized controlled study is explore the effects of siliphos-selenium-methionine-alpha lipoic acid + metformin versus metformin in patients with fatty liver and non-alcoholic steatohepatitis about biochemical and echosonographic parameters.

Conditions

• Liver Disease

Interventions

Type	Name	Description
DRUG	Metformin	Patients with Steatohepatitis treated with diet, exercise and metformin
DIETARY_SUPPLEMENT	Siliphos+ Selenium - Methionine + Alpha Lipoic Acid	Patients with Steatohepatitis treated with diet, exercise, metformin and Siliphos (140mg) + Selenium (15 mcg) - Methionine (3mg) + Alpha Lipoic Acid (200mg), two tablets BID
DIETARY_SUPPLEMENT	Siliphos+ Selenium - Methionine + Alpha Lipoic Acid	Patients with fatty liver treated with diet, exercise, metformin and Siliphos (140mg) + Selenium (15 mcg) - Methionine (3mg) + Alpha Lipoic Acid (200mg), two tablets BID
DRUG	Metformin	Patients with fatty liver treated with diet, exercise and metformin

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-03-01
• Completion: 2014-06-01
• First posted: 2012-07-26
• Last updated: 2014-08-20

Locations

1 site across 1 country: Mexico