Rutin and Vitamin C in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

NCT07310407 | Not Yet Recruiting Phase 2

• 1 other identifier: REC Approval Number: REC # 414
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

evaluate the combined effects of Rutin and Vitamin C versus Vitamin C alone on selected oxidative stress markers, inflammation, hepatic steatosis regression, and associated metabolic parameters in patients with MASLD

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

• • Change in tumor necrosis factor-alpha (TNF-α) levels from baseline to week 12.

  Serum TNF-α, a key biomarker of inflammation in MASLD

  12 weeks

Secondary Outcomes (1)

• • Change in serum malondialdehyde (MDA) levels from baseline to week 12.

  12 weeks

Study Arms (3)

Ruta C group

EXPERIMENTAL

Drug: Rutin + Vitamin C - Oral, two tablets containing 60 mg Rutin + 160 mg Vitamin C, three times daily for 12 weeks, plus lifestyle intervention (Mediterranean diet and structured exercise).

Drug: Rutin + Vitamin C

Vitamin C group

EXPERIMENTAL

Drug: Vitamin C - Oral capsules, 500 mg, twice daily for 12 weeks, plus lifestyle intervention (Mediterranean diet and structured exercise).

Drug: Vitamin C 500mg

Control group

EXPERIMENTAL

Behavioral: Lifestyle Intervention - Mediterranean diet focusing on fruits, vegetables, whole grains, healthy fats, and structured exercise program for 12 weeks

Behavioral: Lifestyle Intervention

Interventions

Rutin + Vitamin C DRUG

Type: Drug (Combination therapy) Details: Oral administration of two tablets containing 60 mg Rutin + 160 mg Vitamin C, taken three times daily for 12 weeks.

Also known as: Ruta C

Ruta C group

Vitamin C 500mg DRUG

Type: Drug (Single agent) Oral administration of Vitamin C 500 mg, taken twice daily for 12 weeks

Also known as: C-Retard

Vitamin C group

Lifestyle Intervention BEHAVIORAL

Mediterranean diet focusing on fruits, vegetables, whole grains, healthy fats, plus structured exercise program for 12 weeks.

Also known as: diet and exercise

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of Metabolic-Associated Steatotic Liver Disease (MASLD).

You may not qualify if:

• HCV infection.
• HBV infection.
• Patients with a history of significant alcohol consumption.
• Autoimmune hepatitis.
• Celiac disease (CD).
• Wilson's disease (WD).
• Haemochromatosis.
• Drugs: Tamoxifen, Valproic acid, Amiodarone, Methotrexate, steroids and immunosuppressive agents, oral contraceptive pills, or drugs that can affect liver profile.
• Hypo or hyper thyroidism.
• Bypass surgeries.
• TPN (Total Parenteral Nutrition).
• Pregnant individuals or patients planning to become pregnant.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

National Hepatology and Tropical Medicine Research Institute (NHTMRI)

Cairo, Egypt

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Rutin; Ascorbic Acid; Diet; Exercise

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sara M Zaki, Professor

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Shaimaa s Bashoaib, master

CONTACT

+201091316484; shaimaa.salem22@pharma.asu.edu.eg

Sarah M Fahmy, Asso Prof

CONTACT

+201127666522; sarah.farid@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ain Shams University

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)