Study to Evaluate the Effect of RGMA001 on Patients With Non Alcoholic Fatty Liver Disease (NAFLD)
|ClinicalTrials.gov Identifier: NCT01511523|
Recruitment Status : Unknown
Verified January 2012 by Biovil Research Group, LLC.
Recruitment status was: Enrolling by invitation
First Posted : January 18, 2012
Last Update Posted : March 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Non Alcoholic Fatty Liver Disease||Dietary Supplement: RGMA001 Dietary Supplement: Sugar Pill||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RGMA001 on Patients With Non Alcoholic Fatty Liver Disease (NAFLD).|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||October 2012|
Active Comparator: RGMA001
Proprietary blend of Vitamin E, Silymarin, and Carnitine.
Dietary Supplement: RGMA001
3 capsules administered BID once a day.
Placebo Comparator: Sugar Pill
Dietary Supplement: Sugar Pill
- Efficacy [ Time Frame: 30 weeks ]Normalization of hepatic AST, ALT, y-GT, albumin, alkaline phosphatase and total bilirubin.
- Safety [ Time Frame: 30 weeks ]Vital signs, BMI, symptom directed physical exam, pregnancy tests, laboratory tests (hematology, and chemistry), clinical adverse events, dose modifications and treatment discontinuations related to adverse events or laboratory abnormalities.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511523
|United States, North Carolina|
|Cumberland Research Associates, LLC|
|Fayetteville, North Carolina, United States, 28304|
|Principal Investigator:||John Poulos, MD||Cumberland Research Associates|