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

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

This study is testing whether taking diosmin tablets every day for three months can help improve liver health in non-diabetic patients with non-alcoholic fatty liver disease.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tanta University (other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Tanta)
• Trial ID: NCT05942547 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are non-diabetic adults aged over 18 with a confirmed diagnosis of NASH and a BMI between 25 and 40 kg/m2.

Not a fit: Patients with type 2 diabetes, severe obesity (BMI ≥ 40 kg/m2), or significant alcohol consumption may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from non-alcoholic steatohepatitis.

How similar studies have performed: While the use of diosmin in liver disease is not widely studied, similar approaches targeting fatty liver disease have shown promise in other trials.

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.

Where this trial is running

Tanta

• Tanta University — Tanta, Egypt (RECRUITING)

Study contacts

• Principal investigator: tarek mohamed mostafa, professor — Tanta University
• Study coordinator: merna tarek elsaeed

Conditions: Non Alcoholic Steatohepatitis