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NCT Number: NCT07310407

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

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

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Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Hepatology and Tropical Medicine Research Institute (NHTMRI)

Cairo, Egypt

About this study

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is a common liver disorder with risks of progression to fibrosis, cirrhosis, and hepatocellular carcinoma.

Its global prevalence is high, driven by oxidative stress and impaired antioxidant defenses, while no approved pharmacological treatments currently exist. Nutritional agents such as vitamin C and rutin show promise in improving liver function and reducing oxidative damage.

This study will evaluate their combined effects in addressing MASLD's multifactorial pathology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Ruta C

Vitamin C 500mg

Drug

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

Other names: C-Retard

Lifestyle Intervention

Behavioral

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

Other names: diet and exercise

Primary outcomes

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

    Time frame: 12 weeks

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

Secondary outcomes

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

    Time frame: 12 weeks

    Malondialdehyde (MDA) is a well-established biomarker of oxidative stress in MASLD, reflecting lipid peroxidation and liver injury.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah M Fahmy, Asso Prof

CONTACT

[email protected]

+201127666522

Shaimaa s Bashoaib, master

CONTACT

[email protected]

+201091316484

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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