Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Non Alcoholic Fatty Liver Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Clinical trial, randomized, double-blind and controlledMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-blindPrimary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 60 years
Gender
Both males and females

Description

Non-Alcoholic Fatty Liver Disease (NAFLD) is one of the most prevalent chronic liver diseases in Brazil. It has a significantly increasing incidence today and is considered an important global health problem. It affects approximately 20 to 30% of the adult population and increases according to the s...

Non-Alcoholic Fatty Liver Disease (NAFLD) is one of the most prevalent chronic liver diseases in Brazil. It has a significantly increasing incidence today and is considered an important global health problem. It affects approximately 20 to 30% of the adult population and increases according to the severity of the risk factors. The diagnosis of this disease usually occurs in 10 to 20% of the non-obese individuals, 50% in the overweight and 80 to 90% in the obese, being twice as present in individuals with Metabolic Syndrome. Pharmacological treatment options for NAFLD are still limited and Silybum marianum, one of the most sought-after herbal remedies in patients with liver disease, is commonly used by patients because of the claim of the hepatoprotective effect of silymarin. Studies have demonstrated the therapeutic potential of silymarin in patients with NAFLD, but clinical trials with more judicious methodological designs is still needed to prove these effects. Thus, this project aims to evaluate the effect of silymarin on laboratory markers and clinical evolution of adult patients with DHGNA seen at the Clinic of Nutrition and Hepatology of Edgard Santos Hospital, as well as to identify the dietary pattern of these individuals. It is also intended to develop and validate a Food Frequency Questionnaire (FFQ) for this patient population. A randomized, double-blind, controlled clinical trial lasting 12 weeks will be performed.

Tracking Information

NCT #
NCT03749070
Collaborators
Not Provided
Investigators
Not Provided