sepsis. Other sepsis
Conditions
Interventions
Intervention 1: Intervention group: Oral administration of enteric-coated capsules containing 1100 µg allicin every 8 hours for 7 days. Intervention 2: Control group: Oral administration of placebo ca
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age = 18 years and in generally healthy condition before sepsis Confirmed diagnosis of sepsis with pulmonary (lung) origin Not pregnant or breastfeeding
Exclusion criteria
Exclusion criteria: History of allergy to allicin (garlic or onion) History of hypotension or gastrointestinal bleeding Current use of warfarin Potential interaction of garlic with oral anticoagulant drugs Patients with immunodeficiency (e.g., undergoing chemotherapy, organ or bone marrow transplantation, or autoimmune diseases) Patients with multi-organ failure, hepatic or renal failure, neuromuscular disorders, or autoimmune diseases Increased risk of bleeding or occurrence of clinical bleeding from any source (considered an interfering factor leading to exclusion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum C-Reactive Protein level from day 1 to day 7. Timepoint: At baseline (day 1) and after 7 days of intervention. Method of measurement: Blood test using enzyme-linked immunosorbent assay (ELISA) method.;Change in serum procalcitonin level from day 1 to day 7. Timepoint: At baseline and on day 7. Method of measurement: Quantitative immunoassay method.;Change in SOFA score from day 1 to day 7. Timepoint: At baseline and on day 7. Method of measurement: Clinical assessment using standard sequential organ failure assessment score form. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in APACHE II score from day 1 to day 7. Timepoint: At baseline and on day 7. Method of measurement: Clinical assessment based on standard Acute Physiology and Chronic Health Evaluation II (APACHE II) scoring system.;Duration of non-invasive ventilation (NIV) dependency. Timepoint: During the 7-day ICU follow-up period. Method of measurement: Daily recording of non-invasive ventilation (NIV) requirement in patient’s clinical record.;Requirement of vasoactive drugs during hospitalization. Timepoint: During the first 7 days of ICU stay. Method of measurement: Documentation of type and dosage of vasoactive drugs in clinical record.;Incidence of hospital-acquired infections (HAI) during hospitalization. Timepoint: Until ICU discharge. Method of measurement: Clinical and microbiological evaluation based on CDC criteria.;Length of ICU stay. Timepoint: From admission to ICU discharge. Method of measurement: Recording total ICU stay duration from medical record. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactVahid Nourbakshsh
Mashhad University of Medical Sciences
Outcome results
None listed