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The effects of saffron supplementation on sepsis patients

The effects of saffron supplementation on oxidative stress biomarkers, inflammatory factors, and clinical outcomes in sepsis patients admitted to the intensive care unit (ICU): A double-blind randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201129049534N8
Enrollment
90
Registered
2024-03-17
Start date
2024-05-04
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis patients.

Interventions

Intervention 1: Intervention group: 100 mg of saffron in the form of a 100 mg tablet once a day for 7 days from Mojtahedi Commercial Company (transforming the powder into tablets will be done at the F

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 80 years Consent of the patient or his legal guardian Digestive system with normal function and intestinal nutrition criteria Diagnosis of sepsis based on sepsis-3 criteria and confirmation anesthesiologist or infectious disease specialist.

Exclusion criteria

Exclusion criteria: Patient or his legal guardian dissatisfaction Patients who are hospitalized in the ICU for less than 48 hours or who cannot be fed enterally Patients who do not have an indication for enteral nutrition on the first day, and based on the diagnosis of the special care department, it is confirmed and predicted that they will not be able to receive enteral nutrition in the future. Patients who have cancer and are undergoing chemotherapy and taking cisplatin. Patients with congenital and immune disorders, kidney and liver failure, and pancreatitis. Patients taking anticonvulsants phenobarbital, Levetiracetam and phenytoin. Patients undergoing dialysis. Pregnancy and breastfeeding Septic shock or severe sepsis Patients expected to die within 2 days of admission to the ICU. Patients with BMI<18.5 kg/m2 Patients using other herbal supplements Allergy to herbal supplements or spices Patients with GCS levels less than 3 or more than 13

Design outcomes

Primary

MeasureTime frame
C reactive Protein (CRP). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Erythrocyte sedimentation rate (ESR). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Interleukin-6 (IL-6). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Interleukin-18 (IL-18). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Tumor necrosis factor-alpha (TNF-a). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Lactate dehydrogenase (LDH). Timepoint: At baseline and end of the study. Method of measurement: Commercial enzymatic kit.;Total antioxidant capacity (TAC). Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Superoxide dismutase (SOD). Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Malondialdehyde (MDA). Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Glutathione peroxidase (GPx). Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Catalase. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.

Secondary

MeasureTime frame
28-day mortality rate. Timepoint: After 28 days of follow-up. Method of measurement: Mathematically dividing the number of dead people by the total number of people using hospital records or telephone follow-up.;Complete blood count (CBC). Timepoint: At baseline and end of the study. Method of measurement: Auto hematology analyzers.;Glasgow Coma Scale (GCS). Timepoint: At baseline and end of the study. Method of measurement: hospital records.;APACHE II Score. Timepoint: At baseline and end of the study. Method of measurement: hospital records.;SOFA score. Timepoint: At baseline and end of the study. Method of measurement: hospital records.;NUTRIC score. Timepoint: At baseline and end of the study. Method of measurement: hospital records.;Potassium. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit and the ion-selective electrode method.;Sodium. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit and the ion-selective electrode method.;Calcium. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Magnesium. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Chlorine. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit and the ion-selective electrode method.;Phosphorus. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Blood Sugar. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Alkaline Phosphatase. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Alanine Aminotransferase. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Aspartate Aminotransferase. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Albumin. Timepoint: At baseline and

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Bagherniya

Esfahan University of Medical Sciences

bagherniya@nutr.mui.ac.ir+98 31 3972 3138

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026