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Evaluation of the effect of Coenzyme Q10 on biomarkers of oxidative stress and neurological status of patients with moderate or severe traumatic brain injury hospitalized in intensive care unit

Evaluation of the effect of Coenzyme Q10 on biomarkers of oxidative stress and neurological status of patients with moderate or severe traumatic brain injury hospitalized in intensive care unit

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231017059754N1
Enrollment
48
Registered
2023-10-31
Start date
2023-11-11
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Traumatic brain injury. Intracranial injury

Interventions

Intervention 1: Intervention group: patients in drug group will receive Coenzyme Q10 tablet (under license of Golden Life
Darman Yab Darou company), 600 mg daily for 3 days. Intervention 2: Control group: patients in control group will receive placebo (prepared in Faculty of Pharmacy) for 3 days.

Sponsors

Semnan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged 16 or above Patients with moderate or severe traumatic brain injury (Glasgow Coma Scale= 3-12) Admission to intensive care unit within 72 hours after brain injury Healthy gastrointestinal tract (capable of oral ingestion /gavage of drug) Not receiving warfarin

Exclusion criteria

Exclusion criteria: Hepatic failure (class C according to Child-pugh) Renal failure (need dialysis) Severe heart failure (class 3 and 4 according to New York heart association) Patients with sepsis

Design outcomes

Primary

MeasureTime frame
Changes in biomarkers of oxidative stress (MDA, SOD). Timepoint: Days 1 and 3 of intervention. Method of measurement: ELISA kit.;Glasgow Coma Scale. Timepoint: Days 1 to 5. Method of measurement: GCS table.;Glasgow Outcome Scale. Timepoint: ??At the time of discharge from ICU and hospital. Method of measurement: GOS table.

Secondary

MeasureTime frame
Sequential Organ Failure Assessment (SOFA). Timepoint: Days 1, 3 and 5. Method of measurement: SOFA table.;Mortality rate of patients. Timepoint: After intervention until discharge from hospital. Method of measurement: Observation.;Length of hospitalization. Timepoint: At discharge day. Method of measurement: Number of hospitalization days.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdi Saghiri Ganjeh

Semnan University of Medical Sciences

saghirimahdi4@gmail.com+98 23 3142 0000

Outcome results

None listed

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