NAFLDPhase 2NCT07310407
Rutin and Vitamin C in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
A Phase 2 study testing Rutin + Vitamin C, Vitamin C 500mg and Lifestyle Intervention in people with NAFLD, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- NAFLD
- What is being tested?
- Rutin + Vitamin C, Vitamin C 500mg and Lifestyle Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Metabolic-Associated Steatotic Liver Disease (MASLD).
Who cannot join
- HCV infection.
- HBV infection.
- Patients with a history of significant alcohol consumption.
- Autoimmune hepatitis.
- Celiac disease (CD).
- Wilson's disease (WD).
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
National Hepatology and Tropical Medicine Research Institute (NHTMRI)
Cairo
About this study
Official title: Evaluation of the Effect of 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
Read the 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.
- Conditions
- NAFLD
- Being tested
- Rutin + Vitamin C, Vitamin C 500mg, Lifestyle Intervention
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rutin + Vitamin CDrug
Also called Ruta 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.
Vitamin C 500mgDrug
Also called C-Retard
Type: Drug (Single agent) Oral administration of Vitamin C 500 mg, taken twice daily for 12 weeks
Lifestyle InterventionBehavioural
Also called diet and exercise
Mediterranean diet focusing on fruits, vegetables, whole grains, healthy fats, plus structured exercise program for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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 Receives: Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Change in tumor necrosis factor-alpha (TNF-α) levels from baseline to week 12.
Serum TNF-α, a key biomarker of inflammation in MASLD
Measured: 12 weeks
Secondary outcomes (1)
• Change in serum malondialdehyde (MDA) levels from baseline to week 12.
Malondialdehyde (MDA) is a well-established biomarker of oxidative stress in MASLD, reflecting lipid peroxidation and liver injury.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa salem, Ain Shams University
- Investigators
- Sara M Zaki, Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310407
- Sponsor's protocol ID
- REC Approval Number: REC # 414
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Rutin and Vitamin C in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
- ClinicalTrials.gov ID
- NCT07310407
- Acronym / sponsor ID
- REC Approval Number: REC # 414
- Conditions
- NAFLD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ruta C group | Experimental | Drug: Rutin + Vitamin CDrug: 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). |
| Vitamin C group | Experimental | Drug: Vitamin C 500mgDrug: Vitamin C - Oral capsules, 500 mg, twice daily for 12 weeks, plus lifestyle intervention (Mediterranean diet and structured exercise). |
| Control group | Experimental | Behavioral: Lifestyle InterventionBehavioral: Lifestyle Intervention - Mediterranean diet focusing on fruits, vegetables, whole grains, healthy fats, and structured exercise program for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed diagnosis of Metabolic-Associated Steatotic Liver Disease (MASLD).
Key exclusion criteria (12 listed)
- HCV infection.
- HBV infection.
- Patients with a history of significant alcohol consumption.
- Autoimmune hepatitis.
- Celiac disease (CD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rutin + Vitamin CAlso: Ruta CType: 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 | Ruta C group |
| Vitamin C 500mgAlso: C-RetardType: Drug (Single agent) Oral administration of Vitamin C 500 mg, taken twice daily for 12 weeks | Drug | Vitamin C group |
| Lifestyle InterventionAlso: diet and exerciseMediterranean diet focusing on fruits, vegetables, whole grains, healthy fats, plus structured exercise program for 12 weeks. | Behavioural | Control group |
Primary outcome
• 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
1 secondary outcome
• Change in serum malondialdehyde (MDA) levels from baseline to week 12.
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara M Zaki, Professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rutin + Vitamin C, Vitamin C 500mg and Lifestyle Intervention in people with NAFLD, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaimaa s Bashoaib, master (+201091316484, shaimaa.salem22@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Change in tumor necrosis factor-alpha (TNF-α) levels from baseline to week 12. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.