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

Launched by TANTA UNIVERSITY · Jul 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called diosmin on patients who have a liver condition known as non-alcoholic steatohepatitis (NASH), but who do not have diabetes. The trial will last for three months and involves taking diosmin tablets daily. The main goal is to see if diosmin can help improve liver health and if it is safe for people to use.

To be eligible for this study, participants need to be adults over 18 years old with a body mass index (BMI) between 25 and 40, indicating they are overweight or obese. They must also have a confirmed diagnosis of NASH based on specific tests. However, individuals with certain conditions, such as obesity with a BMI over 40, diabetes, or a history of liver disease, among other criteria, will not be able to participate. If you join the study, you'll be monitored closely to ensure your safety, and you’ll receive information on how the treatment is affecting your liver health throughout the trial.

Gender

ALL

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.