Non Alcoholic Fatty Liver Disease. Nonalcoholic steatohepatitis (NASH)
Conditions
Interventions
Intervention 1: Intervention group: ProGsterol 3 grams sachet. Intervention 2: Control group: 3 grams Placebo sachet.
Sponsors
VIRA RAHESH PHARMED Pharmaceutical Co
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Non-alcoholic fatty liver disease CAP score more than 268 Decibel in Fibroscan BMI 25 to 45 Kg/M2 Consent to participate in the study and signing a written informed consent form Be able to cooperate with the study visits
Exclusion criteria
Exclusion criteria: Alcohol consumption more than 20 grams per day in women and more than 30 grams per day in men Viral hepatitis, autoimmune hepatitis, hemochromatosis Cirrhosis or irreversible liver disease Uncontrolled type 1 and type 2 diabetes (HbA1c more than 9%) Active cancer or history of cancer in the past 5 years Heart failure or kidney failure Weight loss or weight gain more than 5% of body weight in the past 3 months or more than 10% of body weight in the past 6 months History of bariatric surgery Use of weight loss medications Taking thiazolidinedione drugs, GLP1 agonists, SGLT2 inhibitors, and vitamin E Pregnancy or breastfeeding Allergy to the active ingredient of the product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAP Score in Fibroscan. Timepoint: Before intervention, Month 3 and 6 after intervention. Method of measurement: Fibroscan.;Liver Function Test. Timepoint: Before intervention, Month 3 and 6 after intervention. Method of measurement: Blood Sample. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose. Timepoint: Before intervention, Month 3 and 6 after intervention. Method of measurement: Blood Sample.;Insulin Level. Timepoint: Before intervention, Month 3 and 6 after intervention. Method of measurement: Blood Sample.;HbA1c. Timepoint: Before intervention, Month 3 and 6 after intervention. Method of measurement: Blood Sample.;Lipid Profile. Timepoint: Before intervention, Month 3 and 6 after intervention. Method of measurement: Blood Sample. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHossein Poustchi
Tehran University of Medical Sciences
Outcome results
None listed