From 76 male patients above 15 year-old with multiple trauma and diagnosis of DAI who are admitted at hospital with GCS score< 8 within first 6 hours of their trauma we select two groups consist of 33 patients randomly and administer medroxi progesterone tablet (1mg/kg or 30 mg/BID) via NG tube for 5 days to one group, the control group don’t take this drug. Finally the GCS and GOS of them will be checked and compared till the time of discharge. Only the nurses giving the drug to patients are aware of those taking the drug so the study is single-blinded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011225230N1
Registration date:2010-12-23, 1389/10/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-23, 1389/10/02
Registrant information
Name
Moslem Shakery
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 7927
Email address
shakerym@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-08-23, 1390/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of progesterone administration on outcome of patients with diffuse axonal injury due to severe head trauma
Public title
Effect of progesterone administration on outcome of patients with diffuse axonal injury due to severe head trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: men with a diagnosis of Diffuse Axonal Injury and GCS<8 Exclusion criteria: female sex and male under 15 years old
Age
From 15 years old to 100 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
moderote disability good Recovery ، server disbility ، vegetative، death
Intervention groups
1
Description
Intervention groups: male patients above 15 year-old with multiple trauma and diagnosis of DAI who are admitted at hospital with GCS score< 8 within first 6 hours of their trauma this group consist of patients randomly and administer medroxi progesterone tablet (1mg/kg or 30 mg/BID) via NG tube for 5 day .
Category
Treatment - Drugs
2
Description
control groups: did not receive progesterone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Moslem Shakery
Street address
Vice chancellor for research, Tabriz University of Medical Sciences , Golgasht Ave,
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Moslem Shakery
Position
Associate professor
Other areas of specialty/work
Street address
Imam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 1333 7927
Fax
Email
shakerym@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Moslem Shakery
Position
Associate professor
Other areas of specialty/work
Street address
Imam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 1333 7927
Fax
Email
shakerym@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohamad Reza Bustani
Position
Resident of neurosurgery
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)