Protective effect of Melatonin on clinical outcomes in patients with acute ischemic stroke

Evaluation of the Effect of Melatonin on Clinical Outcomes in Patients with Acute Ischemic Stroke: a Randomized Double-Blind Placebo-Controlled Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231220060484N1

Enrollment

Registered

2023-12-27

Start date

2023-12-19

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Acute ischemia stroke. Cerebral ischemia

Interventions

Intervention 1: Intervention group: routine treatment plus melatonin tablets (made by Jalinus Pharmaceutical Co.) 10 mg daily for 5 days. Intervention 2: Control group: routine treatment plus placebo

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Age:18 to 85 years old Occurrence of stroke within the past 24 hours NIHSS score of at least 4 and at most 27 Not eligible for thrombolytic therapy and thrombectomy

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Acute or chronic intracranial hemorrhage or aneurism Any type of cognitive or behavioral disorder Concurrent inflammatory disease and/or malignancy Patients with transient ischemic attacks Sensitivity to Melatonin

Design outcomes

Primary

Measure	Time frame
The severity of neurological function. Timepoint: Before the intervention and on the fifth day and one and three months after the intervention. Method of measurement: Using the National Institutes of Health Stroke (NIHSS) questionnaire and the modified Rankin Scale (mRS) questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmirhossein Ghanbarzamani

Islamic Azad University

amirh.ghzamani@gmail.com+98 21 2264 0056

Outcome results

None listed

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