Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis
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ClinicalTrials.gov Identifier: NCT01650181 |
Recruitment Status :
Completed
First Posted : July 26, 2012
Last Update Posted : August 20, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | July 11, 2012 | |||
First Posted Date ICMJE | July 26, 2012 | |||
Last Update Posted Date | August 20, 2014 | |||
Study Start Date ICMJE | November 2011 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Impact on biochemical and echosonographic parameters [ Time Frame: 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).
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Identify changes in anthropometric parameters [ Time Frame: 6 months ] Identify and measure changes in anthropometrics parameters of metabolic syndrome like BMI, fasting glucose, lipid profile, arterial pressure, abdominal perimeter, waist index.
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis | |||
Official Title ICMJE | Biochemical and Echosonographic Impacts Using Siliphos-Selenium-Methionine-Alpha Lipoic Acid + Metformin Versus Metformin in Patients With Fatty Liver and Steatohepatitis | |||
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. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Supportive Care |
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Condition ICMJE | Liver Disease | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
50 | |||
Original Estimated Enrollment ICMJE |
40 | |||
Actual Study Completion Date ICMJE | June 2014 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Mexico | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01650181 | |||
Other Study ID Numbers ICMJE | GAS-399-11/11/1 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | |||
Verification Date | August 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |