The aim of the present study is to determine the effect of oral melatonin on the clinical feature in patients with ischemic stroke .
Design
A randomized, double-blind, clinical trial study, single center, controlled placebo, 60 Samples selected via patients with ischemic stroke referred to the emergency of Amiralmomenin Hospitals of Arak in 8 months and block randomized into two groups.
Settings and conduct
60 patients referring to Amiralmomenin hospital diagnosed as ischemic stroke will be randomly allocated to receive either melatonin or placebo. Patients in the intervention group will receive 1 melatonin tablet (3 mg) every night from the beginning of the study to the time of discharge and patients whom randomized to placebo group will received placebo tablets every night from the beginning of the study to the time of discharge. melatonin and placebo will be encapsulated and for this reason patients and assessing physicians do not have any knowledge about the type of treatment.
Participants/Inclusion and exclusion criteria
inclusion criteria: Patients admitted in Amiralmomenin Hospital of Arak city with acute ischemic stroke approved by a neurologist and imaging; Those who aged between 18 years and 80 years exclusion criteria: Unwillingness to cooperate; pregnancy and other major diseases that would prevent follow-up.
Intervention groups
Patients in the intervention group will receive 1 melatonin tablet (3 mg) every night from the beginning of the study to the time of discharge. patients whom randomized to placebo group will received placebo tablets every night from the beginning of the study to the time of discharge.
Main outcome variables
Main outcome measures: Sleep quality measured at before and one month after intervention; Vital signs measured at before intervention, then every 6 hours; Volume of red blood cells measured at before intervention, then every 48 hours.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130424013110N7
Registration date:2019-08-24, 1398/06/02
Registration timing:registered_while_recruiting
Last update:2019-08-24, 1398/06/02
Update count:0
Registration date
2019-08-24, 1398/06/02
Registrant information
Name
Mehdi Harorani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
m.harorany@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral melatonin on the clinical feature in patients with ischemic stroke: a randomized clinical trial
Public title
The effect of oral melatonin on the clinical feature in patients with ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 80 years old
Patients satisfaction
GCS 14-15
receiving narcotics and sedatives at least six hours previously
Ischemic stroke
Exclusion criteria:
Recent use of CNS depressant drugs
Impending death
Unwillingness to cooperate
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study the randomization will be done using blocking method.
Blinding (investigator's opinion)
Double blinded
Blinding description
melatonin and placebo will be encapsulated and for this reason patients and assessing physicians do not have any knowledge about the type of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38149 - 5 - 7558
Approval date
2019-07-07, 1398/04/16
Ethics committee reference number
IR.ARAKMU.REC.1398.98
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Sleep quality
Timepoint
Befor intervention and 1 month after start of intervention
Method of measurement
The Pittsburgh Sleep Quality Index
2
Description
Vital signs
Timepoint
Before intervention, then every 6 hours
Method of measurement
Blood pressure will measured by Sphygmomanometer, pulse and breathing by counting in a minute by a hand watch.
3
Description
Volume of red blood cells
Timepoint
Before intervention, then every 48 hours
Method of measurement
in mili liter
4
Description
Score of NIHSS scale
Timepoint
Before intervention, time of discharge and one month after intervention
Method of measurement
NIHSS questionnaire (0-42) score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group will receive 1 melatonin tablet (3 mg) every night from the beginning of the study to the time of discharge.
Category
Treatment - Drugs
2
Description
Control group: patients whom randomized to placebo group will received placebo tablets every night from the beginning of the study to the time of discharge.