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

NCT05942547 | Unknown Phase 3

• 1 other identifier: 3626MS202/6/23
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non Alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (2)

• the change in ultrasound including NAFLD fibrosis scor

  The change in ultrasound through decreasing liver echogenicity, Lower echoes in the hepatic parenchyma, no vessel blurring, and decrease narrowing of the lumen of the hepatic veins Ultrasonography Fatty Liver Indicator (US-FLI) \<2

  at baseline then after 3 months

• The change in fibrosis risk score

  Score \<-1.455 predicts absence of significant fibrosis (F0-F2)

  at baseline then after 3 months

Secondary Outcomes (3)

• The secondary outcome is the change in biological biomarkers and other measured parameters

  at baseline then after 3 months

• secondary outcome is the change in biological biomarkers and other measured parameters

  at baseline then after 3 months

• secondary outcome is the change in biological biomarkers and other measured parameters

  at baseline then after 3 months

Study Arms (2)

diosmin group

EXPERIMENTAL

(Diosmin group; n = 24):will receive 600 mg twice daily

Drug: Diosmin

placebo group

PLACEBO COMPARATOR

placebo group n=24 :will receive placebo twice daily

Drug: Placebo

Interventions

Diosmin DRUG

diosmin 600mg twice daily

diosmin group

Placebo DRUG

twice daily

placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Diosmin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• tarek mohamed mostafa, professor

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

merna tarek elsaeed

CONTACT

00201551813013; sgama676@gmail.com

amira bahaa ismail

CONTACT

00201142760505; amira7794.aa@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacist

Model Details: This study will be a randomized double-blind placebo-controlled parallel study that will involve 48 non-diabetic patients with confirmed diagnosis of NASH. . 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.

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 12, 2023
• Study Start: July 10, 2023
• Primary Completion: October 10, 2023
• Study Completion: June 10, 2025
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)