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Life sciences · Interventional Study
ClinicalTrials.gov · November 6, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07922213). This is a study registration, not published results. Lead sponsor: Ain Shams University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 72 participants (ESTIMATED). Conditions: Sepsis. Interventions: DRUG: Rutin plus Vitamin C; DRUG: Vitamin C. Primary outcome measures: To evaluate the impact of Ruta C (rutin in combination with vitamin C) or vitamin C alone on length of ICU stay. , From ICU admission until ICU discharge or death, whichever occurs first, assessed up to 28 days.. Brief summary: The goal of this prospective, randomized, open-label, controlled clinical trial is to evaluate the efficacy and safety of rutin combined with vitamin C (Ruta C) and vitamin C alone as adjunctive therapies in adult patients aged 21 years or older with sepsis admitted to the Intensive Care Unit (ICU). The main questions it aims to answer are: Does adding Ruta C or vitamin C alone to standard sepsis treatment reduce the length of ICU stay compared with standard sepsis treatment alone? Do these adjunctive therapies improve clinical outcomes, including 28-day mortality, organ dysfunction, development of septic shock, and the need for mechanical ventilation or vasopressor support? Do these treatments reduce inflammatory and oxidative stress markers, including interleukin-6 (IL-6), malondialdehyde (MDA), C-reactive protein (CRP), and total leukocytic count? Researchers will compare three groups to evaluate whether Ruta C provides additional clinical benefits compared with vitamin C alone or standard sepsis care. A total of 72 patients with sepsis will be randomly assigned in a 1:1:1 ratio to one of three groups: Group A (Ruta C): Participants will receive oral Ruta C tablets containing rutin 60 mg and vitamin C 160 mg, three times daily, in addition to standard sepsis treatment. Group B (Vitamin C): Participants will receive oral vitamin C 500 mg once daily, in addition to standard sepsis treatment. Group C (Control): Participants will receive standard ICU sepsis treatment alone. Study medications will be administered until ICU discharge, death, or development of septic shock. Participants will: Undergo baseline clinical assessments, including APACHE II and SOFA scores, medical history, and demographic data. Have their SOFA scores assessed at baseline, Day 3, Day 7, and every three days thereafter until ICU discharge or death. Undergo blood sampling of approximately 10 mL on Days 1 and 7 (approximately 20 mL in total) to measure IL-6 and MDA. Undergo routine laboratory investigations, including kidney function, liver function, electrolytes, and complete blood count. CRP will be measured on Days 1, 3, and 7, and every three days thereafter until discharge or death. Be monitored for vital signs, mechanical ventilation requirements, vasopressor use, septic shock development, ICU and hospital length of stay, and adverse events. Have in-hospital and 28-day mortality outcomes recorded.