Clinical Study Evaluating the Efficacy and Safety of Diosmin on Non-diabetic Patients With Non-alcoholic Steatohepatitis.

3626MS202/6/23

This is a randomized, controlled study evaluating diosmin tablets administered daily for 3 months. The purpose of the study is to evaluate the efficacy and safety of diosmin on non-diabetic patients with non-alcoholic steatohepatitis.

2023-07-10

2023-10-10

2025-06-10

Recruiting

Early phase I

48

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will be a randomized double-blind placebo-controlled parallel study that will involve 48 non-diabetic patients with confirmed diagnosis of NASH.\n\n. The patients will be randomized in a 1:1 ratio by a neutral researcher using sealed envelopes methods with assignment codes for each available allocation to receive either diosmin 600 mg twice daily (Diosmin group; n = 24) or placebo twice daily (Placebo group; n = 24). The study duration will be 12 weeks.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}

2023-07-12