A clinical trial of comparing the effect of melatonin and placebo on improving the neurological complications, infarct size and sleep and cognitive impairments in patients with ischemic stroke.

Evaluation of melatonin as a potential drug for the improvement of clinical outcome, reduction of infarct size, sleep parameters and cognitive functions in post-stroke patients: A randomized, double blind, placebo-controlled study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201609059566N2

Enrollment

Registered

2016-12-17

Start date

2016-10-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

stroke. Cerebral infarction

Interventions

Intervention 1: placebo (microcrystalline cellulose powder [Avicel], 6mg/day at bed time) for 90 days. Intervention 2: melatonin (6 mg/day at bed time) for 90 days.

Placebo

Treatment - Drugs

placebo (microcrystalline cellulose powder [Avicel], 6mg/day at bed time) for 90 days

melatonin (6 mg/day at bed time) for 90 days

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria : Clinical diagnosis of acute stroke in middle cerebral artery (MCA) territory established by MRI imaging; Males and females between18 to 70 years old; NIHSS score of 5-20 with a motor deficit of 2 or more; Level of consciousness less than 2 in NIHSS scale; Signed informed consent; More than 12 years education Exclusion criteria : Clinically relevant preexisting neurological deficit or previous CVA; Primary intracerebral hemorrhage; Coma; Negative swallow test; History of epilepsy or seizure at onset of stroke; Systolic BP is >220 mmHg, diastolic BP>120 ; Atrial fibrillation or other arrhythmias ; Ejection Fraction less than 30%; Aphasia; Malignancy or premalignant state within 5 years; Significant liver disease (Bilirubin > 20 mmoll/L); Respiratory failure (FEV1 45); Psychiatric illness requiring hospital admission; Chronic kidney disease ; NIHSS> 20 ; Pregnancy or breast feeding; Inability to follow up the instructions of the study; Autoimmune disease; Steroid consumption

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Clinical outcome. Timepoint: 90 days. Method of measurement: NIHSS and MRS questionnairies.;Cognitive function. Timepoint: 90 days. Method of measurement: Addenbrook questionnaire.;Infarct size. Timepoint: 90 days. Method of measurement: Voxel-based volumetry.;Subjective sleep assessment. Timepoint: 90 days. Method of measurement: self-rated 19-item PSQI questionnaire and PIRS questionnaire.;Objective sleep assessment. Timepoint: 90 days. Method of measurement: polysomnography.	—

Measure

Time frame

Clinical outcome. Timepoint: 90 days. Method of measurement: NIHSS and MRS questionnairies.;Cognitive function. Timepoint: 90 days. Method of measurement: Addenbrook questionnaire.;Infarct size. Timepoint: 90 days. Method of measurement: Voxel-based volumetry.;Subjective sleep assessment. Timepoint: 90 days. Method of measurement: self-rated 19-item PSQI questionnaire and PIRS questionnaire.;Objective sleep assessment. Timepoint: 90 days. Method of measurement: polysomnography.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Masoumeh Emamghoreishi

Shiraz University of Medical Science

emamm@sums.ac.ir+98 71 3230 7591

Outcome results

None listed

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