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Investigating the efficacy and safety of thymoquinone on sepsis induced acute kidney injury in patients admitted to the intensive care unit

Investigating the efficacy and safety of thymoquinone on sepsis induced acute kidney injury in patients admitted to the intensive care unit

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151221025641N11
Enrollment
50
Registered
2024-11-27
Start date
2024-11-21
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Acute kidney injury. Acute kidney failure

Interventions

Intervention 1: Intervention group: Black Seed Oil Soft Capsule of Barij Essence, 1000 mg, to be taken orally once daily for 5 days. Intervention 2: Control group: Placebo capsules with an identical a

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Written, voluntary informed consent must be obtained from the patient or their legal representative. The patient must have developed sepsis based on the following criteria: A minimum increase of two points in the SOFA score compared to baseline, along with a confirmed infection. The patient must meet the RIFLE criteria for AKI: Serum creatinine must have increased by at least 1.5 times from baseline; or Urine output must have decreased to less than 0.5 ml/kg/h.

Exclusion criteria

Exclusion criteria: A documented history of allergy to the family of Nigella sativa (black seed) Chronic kidney disease characterized by a creatinine clearance (ClCr) of less than 15 ml/min Pregnant or breastfeeding Death or transfer of the patient to another healthcare facility within the first 72 hours of study enrollment.

Design outcomes

Primary

MeasureTime frame
Evaluation of the Effect of Thymoquinone on SrCr in sepsis associated Acute Kidney Injury. Timepoint: Prior and post intervention (day 1 and 5). Method of measurement: Blood test.;Evaluation of the Effect of Thymoquinone on BUN in sepsis associated Acute Kidney Injury. Timepoint: Prior and post intervention (day 1 and 5). Method of measurement: Blood test.

Secondary

MeasureTime frame
Evaluation of the effect of Thymoquinone on NGAL in sepsis associated Acute Kidney Injury. Timepoint: Prior and post intervention (day 1 and 5). Method of measurement: ELISA kit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParisa Kianpour

Tehran University of Medical Sciences

pk.pioneer1@yahoo.com+98 21 2660 2854

Outcome results

None listed

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