Ruta C and Vitamin C in Sepsis: Adding antioxidants to standard care
Official title: Evaluation of the Effect of Rutin and Vitamin C on Clinical Outcome in Septic ICU Patients
Run by Ain Shams University · NCT07922213 · Data updated 2026-11-12
This trial tests whether adding Ruta C (rutin plus vitamin C) or vitamin C alone to standard sepsis treatment helps adults in the ICU stay shorter and recover better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Status | Recruiting |
| Started | August 1, 2026 |
| Main results expected | June 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07922213 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 21 years or older with sepsis admitted to the ICU, able to swallow tablets, without major exclusions such as septic shock at enrollment or active significant inflammatory disease.
✕Probably not a fit
Patients with septic shock at enrollment, severe liver disease or advanced cancer, or those already on antioxidant therapy may be less likely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized, open-label study compares three groups of adults with sepsis admitted to the ICU: standard care alone, standard care plus vitamin C, and standard care plus Ruta C. The primary aim is to see if these adjunctive therapies reduce ICU length of stay and improve outcomes such as 28-day mortality, organ dysfunction, septic shock incidence, and need for mechanical ventilation or vasopressors. It also looks at changes in inflammatory and oxidative stress markers like IL-6, CRP, MDA, and white blood cell count. Patients must be 21 years or older, meet Sepsis-3 criteria, and be able to take oral tablets, with several exclusions for comorbidities and current therapies. Conducted at Ain Shams University in Cairo, the study randomizes participants to assess potential added benefits of Ruta C over vitamin C alone.
Why it matters
Potential benefit: If successful, Ruta C or vitamin C could become adjunctive options to improve outcomes for adults with sepsis in the ICU.
How similar studies have gone: Prior antioxidant-focused sepsis trials have shown mixed results; this study adds direct comparison between Ruta C and vitamin C in a randomized design.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1-Adult patients aged ≥21 years. 2- Confirmed diagnosis of sepsis based on Sepsis-3 criteria. 3- ICU admission within 24 hours of enrollment. 4-Patients able to swallow oral tablets. Exclusion Criteria: * 1- Patients with active chronic inflammatory or autoimmune diseases. 2- End-stage liver disease or advanced cancer. 3- Initial SOFA score ≥15. 4- Pregnant or breastfeeding women. 5- Patients who are nothing per oral (NPO). 6- Known allergy or hypersensitivity to rutin or vitamin C. 7- Patients already receiving antioxidant therapy before enrollment. 8- Participation in another clinical trial during the last 30 days. 9- Presenting with septic shock at enrollment.
Where it's running
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Al-Demerdash Hospital, Ain Shams University
Cairo, Cairo Governorate, Egypt Recruiting
Study contacts
- Study coordinator: hebaallah adel soliman, BPharm
- Email: heba.allah.adel@pharma.asu.edu.eg
- Phone: 00201121934293
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.