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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01650181

Enrollment

Registered

2012-07-26

Start date

2011-11-30

Completion date

2014-06-30

Last updated

2014-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Disease

Keywords

nafld, nash, fatty liver

Brief 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.

Interventions

DRUGMetformin

Patients with Steatohepatitis treated with diet, exercise and metformin

DIETARY_SUPPLEMENTSiliphos+ 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patients with Metabolic Syndrome according to ATP III Criteria * Non smokers * Without intake of vitamins or herbal medicine for at least one month * Without uncontrolled glycemic levels * Compatible ultrasound and/or histological report

Exclusion criteria

* Alcohol ingest \> 50 gr weekly or chronic alcoholism * Creatine serum \> 2 mg/dL * Potassium serum \> 5.5 mEq/L * Allergic to metformin or any components of the study * Pregnancy * Anomalies of blood coagulation or liver anatomic * Patients with diseases and/or treatment that cause fatty liver or steatohepatitis * Body weight change \> 10% in the last 5 weeks

Design outcomes

Primary

Measure	Time frame	Description
Impact on biochemical and echosonographic parameters	6 months	Identify and measure if patients with metabolic syndrome with NALFD under Siliphos (140mg) + Selenium (15mcg) - Methionine (3mg) + Alfa lipoic acid (200mg) treatment added to conventional therapy improves echosonographic pattern measure accord bright scale and biochemical parameters like LFT´s compared with conventional therapy alone (metformin + diet + exercise).

Secondary

Measure	Time frame	Description
Identify changes in anthropometric parameters	6 months	Identify and measure changes in anthropometrics parameters of metabolic syndrome like BMI, fasting glucose, lipid profile, arterial pressure, abdominal perimeter, waist index.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026