In the random block method, people are divided into two groups, and then medication is administered by the clinical caregiver with a specific code for them, and it is provided to the researcher (student). The researcher evaluates the patients using a questionnaire and records the results based on the patient code. Patients are also not aware of the type of surgery. Also, the analyzer is not aware of the group in which the patient is placed.
Settings and conduct
In the random block method, people are divided into two groups, and then medication is administered by the clinical caregiver with a specific code for them, and it is provided to the researcher (student). The researcher evaluates the patients using a questionnaire and records the results based on the patient code. Patients are also not aware of the type of surgery. Also, the analyzer is not aware of the group in which the patient is placed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with a consciousness coefficient between 9 and 13
Conscious consent of first -degree companions to enter the study
Exclusion criteria: A history of any brain disorders
Liver Function Test normal
Previous use of melatonin.
Intervention groups
For the case group, the treatment of Melatonin begins 48 hours to the first 72 hours immediately after the patient's gaze begins. Three mg daily (once a day) is prescribed before bedtime.
The witness group will also receive the placebo (an ineffective material made at the School of Pharmaceuticals similar to Melatonin for 6 months for 6 months).
Main outcome variables
Glasgow Outcome Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221108056446N5
Registration date:2023-11-27, 1402/09/06
Registration timing:prospective
Last update:2023-11-27, 1402/09/06
Update count:0
Registration date
2023-11-27, 1402/09/06
Registrant information
Name
Mehdi Mahmoodkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 686 3733
Email address
mahmoodkhani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of Melatonin Therapeutic Effect in Patients with Moderate Brain Trauma
Public title
Melatonin in medium brain trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a consciousness coefficient between 9 and 13
Conscious consent of first -degree companions to enter the study
Exclusion criteria:
A history of any brain disorders
Liver function tests normal
Previous use of melatonin.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Easy sampling methods from those who are eligible to enter the study are randomly divided into two groups of cases and control. In this study, the segmentation of individuals is performed as a quadruple block. In this method A reflects the person who receives the intervention and B represents the person in the control group. Considering the four -block block, we give the AABB Code 0, to the ABAB Code 1, to ABBA Code 2, to BAAB Code 3, to BBAA Code 4 and BABA Code 5 to 9. Then, using the random numbers table, select the starting point randomly and then consider the numbers in a row or column. Considering the order of the table numbers, we replace each number we have hit. Finally, 3 people will be divided into two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the random block method, people are divided into two groups, and then medication is administered by the clinical caregiver with a specific code for them, and it is provided to the researcher (student). The researcher evaluates the patients using a questionnaire and records the results based on the patient code. Patients are also not aware of the type of surgery. Also, the analyzer is not aware of the group in which the patient is placed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Hazar Jarib Street, Azadi Square
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.MUI.MED.REC.1402.099
Health conditions studied
1
Description of health condition studied
Moderate brain trauma
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Improve the state of Glasgow Coma Scale (GCS)
Timepoint
One, three and 6 months after the injury
Method of measurement
Glasgow coma scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Melatonin treatment is started for the first 48 hours to 72 hours immediately after the patient's gavage. Three milligrams daily (once a day) is prescribed for the patient before going to bed.
Category
Treatment - Drugs
2
Description
Control group: They will receive a placebo (an ineffective substance made in the Faculty of Pharmacy similar to Melatonin daily for 5 months) in the same way as the case group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra Hospital
Full name of responsible person
Mehdi Shafiei
Street address
Al-Zahra Hospital, Safa Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 310 1971
Email
Mehdishafiei82@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Shafiei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Hazar Jarib Street, Azadi Square
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Shafiei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Hazar Jarib Street, Azadi Square
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Shafiei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Hazar Jarib Street, Azadi Square
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available