Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT05605158
Eligibility Criteria:
Inclusion Criteria:
* Non-diabetic patients.
* Both males and females.
* Age \>18 years old.
* Patient with body mass index (BMI) \> 30 kg/m2.
* Patients with established diagnosis of NASH based on liver ultrasonography, mild to moderate elevation in aminotransferase activities (\>2 but \<5 times upper limit of normal), hepatic steatosis index (HSI) \>36, and HAIR score of 2 or 3.
Exclusion Criteria:
* Patients with BMI \> 40 kg/m2.
* Patients with type 2 diabetes mellitus (T2DM) on the basis of a fasting plasma glucose (FPG) level ≥ 126 mg/dl (7mmol/L) or glycated hemoglobin (HbA1c) \> 6.5% (48 mmol/mol).
* Alcohol consumption greater than 20 g per day for women or greater than 30 g for men for at least three consecutive months over the past 5 years.
* History of viral hepatitis, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, biliary obstruction, alpha-1 antitrypsin deficiency.
* Patients on medications interfere with lipid and carbohydrate metabolisms.
* Patients with heart failure (New York Heart Association (NYHA) class 2-4).
* Patients with history of cardiovascular events within the past 3 months.
* Patients with renal impairment (eGFR\> 45 mL/min/ 1.73 m2).
* Patients with cancer or with a history of cancer treatment over the past 2 years.
* Patients with thyroid disorder.
* Patients on medications associated with steatosis such as Non-steroidal anti-inflammatory drugs (NSAIDs), amiodarone, tamoxifen, estrogen, sodium valproate, corticosteroids, and methotrexate.
* Patients with inflammatory diseases.
* Patients on supplements known to have antioxidant activity such as vitamin E, vitamin C, zinc, and selenium.
* Pregnant and breastfeeding women.
* Females on oral contraceptive pills will be also excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05605158
Study Brief:
Protocol Section:
NCT05605158