Effect of melatonin versus placebo on cerebral edema due to traumatic brain injury: a double-blind randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N581

Enrollment

Registered

2025-10-17

Start date

2025-11-03

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Cerebral edema. Cerebral edema

Interventions

Intervention 1: Intervention group: Routine treatment of traumatic brain injury plus melatonin 3 mg daily orally for one week via gavage. Intervention 2: Control group: Routine treatment of traumatic

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age 18 to 70 years, Brain trauma, Consciousness level 4 to 12 on the Glasgow Coma Scale,

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding, Coagulopathy, History of organ transplantation, Use of immunosuppressive drugs, Use of verapamil or amantadine

Design outcomes

Primary

Measure	Time frame
Cerebral edema status. Timepoint: Before the intervention and then 24 hours, one week and one month after the intervention. Method of measurement: Using CT scan.	—

Secondary

Measure	Time frame
Possible complications (drowsiness, nausea and vomiting, hypersensitivity). Timepoint: 24 hours, one week and one month after the intervention. Method of measurement: By history taking and clinical examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Yavari

Iran University of Medical Sciences

aepharm@gmail.com+98 21 8670 2503

Outcome results

None listed

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