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Effect of Melatonin in brain injury

Evaluation of the effect of melatonin on biomarkers of mitochondrial damage in patients with brain injury hospitalized in Alzahra hospital, Isfahan: A randomized placebo-controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20081208001497N8
Enrollment
60
Registered
2019-05-07
Start date
2019-04-21
Completion date
Unknown
Last updated
2019-05-21

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

Conditions

Brain injury. Intracranial injury

Interventions

Intervention 1: Intervention group: Patients in drug group will be received Melatonin tablet (Razak Pharmaceutical company, Tehran, Iran), 20 mg daily for 5 days. Intervention 2: Control group: Patien

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients (age more than 18) who had traumatic brain injury included skull fracture, subdural hemorrhage, subarachnoid hemorrhage, brain contusion and laceration, intracerebral hemorrhage, intraventricular hemorrhage and traumatic axonal injury Non-traumatic brain injury included strokes, infections, hypoxia and brain tumors Admission within 72 hours after brain injury in intensive care unit or other wards such as neurology or neurosurgery Healthy gastrointestinal tract (capable of oral ingestion or gavage of drug)

Exclusion criteria

Exclusion criteria: Length of hospitalization less than 5 days in intensive care units or other wards Hypersensitivity to melatonin Hepatic failure (class C according to Child-pugh) Renal failure (need dialysis) Severe heart failure (Class 3 and 4 according to Newyork heart association) Sepsis within first 5 days of admission

Design outcomes

Primary

MeasureTime frame
Changes in bio markers of mitochondrial injury. Timepoint: Day 1 and 5 of intervention. Method of measurement: Elisa kit.

Secondary

MeasureTime frame
Mortality rate of patients. Timepoint: 28 days. Method of measurement: Observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSarah Mousavi

Esfahan University of Medical Sciences

s.mousavi@pharm.mui.ac.ir+98 31 3792 7072

Outcome results

None listed

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