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Effect of propolis and melatonin on clinical factors of patients in intensive care units

Evaluation of propolis supplementation and high doses of melatonin effects on oxidative stress indices, inflammatory factors, clinical status in patients with Systemic Inflammatory Response Syndrome (SIRS) in Intensive Care Unit

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181025041460N1
Enrollment
44
Registered
2018-11-06
Start date
2018-12-22
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Systemic Inflammatory Response Syndrome. Systemic Inflammatory Response Syndrome of infectious origin without organ failure

Interventions

Intervention 1: Intervention group: propolis intake with dose of 1000 mg/day for 10 days. Intervention 2: Intervention group: Intervention group: propolis intake with dose of 1000 mg/day plus melaton

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Age between 18-75 years Admission to the intensive care unit with the criteria of systemic inflammatory response syndrome (primary sepsis)

Exclusion criteria

Exclusion criteria: failure to start enteral nutrition during the first 48 hours of admission Patients with autoimmune disorders, cancer and advanced sepsis Sensitivity to bee products or known food allergies Patients with infection of the immunodeficiency virus, severe liver failure Severe and active bleeding

Design outcomes

Primary

MeasureTime frame
Clinical status. Timepoint: At the beginning of the study after 5 and 10 days of the intervention. Method of measurement: SOFA questionnaire.;White Blood Count. Timepoint: At the baseline and 10 days after intervention. Method of measurement: Sysmex K-1000 Hematology Analyzer.;Interleukin-6. Timepoint: At the baseline and 10 days after intervention. Method of measurement: Enzyme-linked immunosorbent assay.;Neutrophils. Timepoint: At the baseline and 10 days after intervention. Method of measurement: Sysmex K-1000 Hematology Analyzer and then the differential counts.;CRP. Timepoint: At the baseline and 10 days after intervention. Method of measurement: kit (Bionik, Iran) with the BT3500 (Biotecnica Instruments SpA -Italy) auto-analyzer.;Nutritional status. Timepoint: At the baseline and 10 days after intervention. Method of measurement: NUTRIC score questionnaire.;MDA. Timepoint: At the baseline and 10 days after intervention. Method of measurement: Fluorimetry.;Gavage intake record. Timepoint: Before and after intervention. Method of measurement: With measurement of amounts of gavage intake for each patient.

Secondary

MeasureTime frame
PAB. Timepoint: At the baseline of the study and 10 days after intervention. Method of measurement: PAB assay.;APACHEII. Timepoint: At the baseline of the study and 10 days after intervention. Method of measurement: APACHEII questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNaseh Pahlavani

Mashhad University of Medical Sciences

PahlavaniN951@mums.ac.ir+98 937 608 1205

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 2, 2026