the Efficacy and Safety of Diosmin on Non-diabetic Patients With Non-alcoholic Steatohepatitis.
Non Alcoholic Steatohepatitis
About this trial
This is an interventional treatment trial for Non Alcoholic Steatohepatitis
Eligibility Criteria
Inclusion Criteria: Non-diabetic patients with or without hypertension. Both males and females. Age >18 years old. Overweight and obese patient: Body mass index (BMI) ≥ 25 kg/m2 <.40 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 (HIS) >36, 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 metabolism (statin, fibrate, beta blockers, thiazide, corticosteroids, etc). Patients with cancer or with a history of cancer. Patients with thyroid disorder. Patients on medications associated with steatosis such as NSAIDs, amiodarone, tamoxifen, estrogen, sodium valproate, corticosteroids, and methotrexate. Patients with inflammatory diseases (rheumatoid arthritis, ulcerative colitis, etc). Patients on supplements known to have antioxidant activity such as vitamin E, vitamin C, zinc, and selenium. Patient with a history of cardiovascular diseases. Patients with arrhythmia or altered heart rate. Patients on blood thinning agents (warfarin, clopidogril, aspirin, etc), anticonvulsants (carbamazepine and phenytoin), muscle relaxants (chlorzoxazone) and non-steroidal anti-inflammatory drugs (diclofenac( in order to avoid potential pharmacodynamics and pharmacokinetic drug interactions with diosmin. Pregnant and breastfeeding women. Females on oral contraceptive pills will be also excluded.
Sites / Locations
- Tanta UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
diosmin group
placebo group
(Diosmin group; n = 24):will receive 600 mg twice daily
placebo group n=24 :will receive placebo twice daily