Evaluating diosmin for treating non-alcoholic fatty liver disease in non-diabetic patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized, controlled study assessing the efficacy and safety of diosmin tablets administered daily for three months to non-diabetic patients diagnosed with non-alcoholic steatohepatitis (NASH). The study will involve 48 participants who will be randomly assigned to receive either diosmin or a placebo in a double-blind manner. Diagnosis of NASH will be confirmed through imaging and specific laboratory criteria. The primary goal is to determine if diosmin can effectively improve liver health in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tanta University
  Tanta, Egypt Recruiting

Study contacts

• Principal investigator: tarek mohamed mostafa, professor — Tanta University
• Study coordinator: merna tarek elsaeed
• Email: sgama676@gmail.com
• Phone: 00201551813013

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.