An interventional study of Rutin plus Vitamin C and Vitamin C in Sepsis, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 72 is below the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
24 patients will receive Ruta C tablets (each containing Rutin 60 mg + Vitamin C 160 mg) orally, administered three times daily (TID) until ICU discharge, death, or development of septic shock, in addition to the standard sepsis treatment provided according to the hospital management protocol.
Drug: Rutin plus Vitamin C
24 patients will receive Vitamin C 500 mg tablets orally, administered once daily (OD) until ICU discharge, death, or development of septic shock, in addition to the standard sepsis treatment provided according to the hospital management protocol.
Drug: Vitamin C
24 patients will receive standard ICU sepsis treatment alone according to the hospital management protocol
Participants will receive one oral Ruta C tablet containing rutin 60 mg and vitamin C 160 mg three times daily, in addition to standard ICU sepsis treatment, until ICU discharge, death, or development of septic shock.
Participants will receive oral vitamin C 500 mg once daily, in addition to standard ICU sepsis treatment, until ICU discharge, death, or development of septic shock.
To evaluate the impact of Ruta C (rutin in combination with vitamin C) or vitamin C alone on length of ICU stay.
Length of ICU stay will be measured as the number of days from the date and time of admission to the intensive care unit until the date and time of ICU discharge or death. ICU length of stay will be compared among patients receiving Ruta C (rutin in combination with vitamin C), vitamin C alone, and the control group.
Time frame: From ICU admission until ICU discharge or death, whichever occurs first, assessed up to 28 days.
Started Aug 2026 (actual). Primary completion is estimated for Jun 2027, 10 months after the start.
Of 301 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 10 months is below that.
Counting every sponsor, half of 324 studies reached it within 22 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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