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Not yet recruiting NCT07310407

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

Phase II Interventional NAFLD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rutin + Vitamin C, Vitamin C 500mg, Lifestyle Intervention.
Who it may be relevant to
Registry conditions: NAFLD. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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.

Interventions

  • Drug Rutin + Vitamin C
    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.
  • Drug Vitamin C 500mg
    Type: Drug (Single agent) Oral administration of Vitamin C 500 mg, taken twice daily for 12 weeks
  • Behavioral Lifestyle Intervention
    Mediterranean diet focusing on fruits, vegetables, whole grains, healthy fats, plus structured exercise program for 12 weeks.

Primary outcome measures

  • • Change in tumor necrosis factor-alpha (TNF-α) levels from baseline to week 12. [Time frame: 12 weeks]
Secondary outcome measures (1)
  • • Change in serum malondialdehyde (MDA) levels from baseline to week 12. [Time frame: 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • National Hepatology and Tropical Medicine Research Institute (NHTMRI) — Cairo

Identifiers

NCT: NCT07310407 · REC Approval Number: REC # 414

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗