Effect of melatonin versus placebo on clinical outcomes in patients with ischemic stroke

Effect of melatonin versus placebo on clinical outcomes in patients with ischemic stroke: a double-blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N378

Enrollment

Registered

2021-01-28

Start date

2021-05-05

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

Acute ischemia stoke. Cerebral ischemia

Interventions

Intervention 1: Intervention group: routine treatment plus melatonin tablets (made by Razak Pharmaceutical Co.) 20 mg daily for 5 days. Intervention 2: Control group: routine treatment plus placebo ta

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Age:18 to 85 years old Acute ischemic stroke for the first time Occurrence of stroke within the past 24 hours Focal neurological disorder NIHSS score of at least 4 and at most 27

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Acute or chronic intracranial hemorrhage or aneurism Any type of cognitive or behavioral disorder Concurrent inflammatory disease Taking any antioxidant combination in the last month 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 ContactEnsieh Rahmani Yeganeh

Hamedan University of Medical Sciences

ncrahmani1995@gmail.com+98 81 3838 0572

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 13, 2026