SepsisNCT07922213
Effect of Rutin and Vitamin C on Outcomes in Adults With Sepsis Admitted to the Intensive Care Unit
A study testing Rutin plus Vitamin C and Vitamin C in people with Sepsis, run by Ain Shams University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Rutin plus Vitamin C and Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 1 Dec 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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, 1 recruiting
- Recruiting
Al-Demerdash Hospital, Ain Shams University
Cairo, Cairo Governorate, 11591
hebaallah adel soliman, BPharm, 00201121934293, heba.allah.adel@pharma.asu.edu.eg
About this study
Official title: Evaluation of the Effect of Rutin and Vitamin C on Clinical Outcome in Septic ICU Patients
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:
Read more
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rutin plus Vitamin CDrug
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.
Vitamin CDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Ruta C group) | Experimental | 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. Receives: Drug: Rutin plus Vitamin C |
| B. Group B (Vitamin C group): | Experimental | 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. Receives: Drug: Vitamin C |
| C. Group C (Control group): | No intervention | 24 patients will receive standard ICU sepsis treatment alone according to the hospital management protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ICU admission until ICU discharge or death, whichever occurs first, assessed up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Aug 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922213
- Sponsor's protocol ID
- REC #481
- Status last verified
- Aug 2026
- First submitted
- 24 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Rutin and Vitamin C on Clinical Outcome in Septic ICU Patients
- ClinicalTrials.gov ID
- NCT07922213
- Acronym / sponsor ID
- REC #481
- Conditions
- Sepsis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 6 Nov 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Ruta C group) | Experimental | Drug: Rutin plus Vitamin C24 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. |
| B. Group B (Vitamin C group): | Experimental | Drug: Vitamin C24 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. |
| C. Group C (Control group): | No intervention | –24 patients will receive standard ICU sepsis treatment alone according to the hospital management protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 plus Vitamin CParticipants 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. | Drug | Group A (Ruta C group) |
| Vitamin CParticipants 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. | Drug | B. Group B (Vitamin C group): |
Primary outcome
To evaluate the impact of Ruta C (rutin in combination with vitamin C) or vitamin C alone on length of ICU stay.
Time frame: From ICU admission until ICU discharge or death, whichever occurs first, assessed up to 28 days.
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.
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 6 Nov 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rutin plus Vitamin C and Vitamin C in people with Sepsis, 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 1 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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.
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 hebaallah adel soliman, BPharm (00201121934293, heba.allah.adel@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the impact of Ruta C (rutin in combination with vitamin C) or vitamin C alone on length of ICU stay. (time frame: From ICU admission until ICU discharge or death, whichever occurs first, assessed up to 28 days.). 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 6 Nov 2026.