The effect of Amantadin and placebo(Acetaminophen) on the level of consciousness in patients with traumatic brain injury with an average level of consciousness
The aim ofThe purpose of this study was to increase the level of consciousness of patients with traumatic brain injury with Amantadine . Entry rate (having a level of consciousness between 9 to 13; passing one day of gavage; absence of kidney and other diseases; lack of susceptibility to Amantadine ; non-pregnancy; Spinal cord; Outcome criteria: patient's death; length of study; incidence of drug poisoning; cardiac and respiratory arrest; incidence of renal scar tissue; seizure; absence of coagulation problems). Research community of patients with cerebral trauma with moderate level of consciousness in Golestan Hospital Ahvaz .The samples is 96 patients who were non -randomized divided into two groups of 48 (Amantadine ) and Acetaminophen (placebo). Intervention of oral administration of 200 mg Amantadine and oral 200 mg of placebo (oral Acetaminophen). During a week, the daily dose is taken as a gavage. The time required for sampling is one month. The variables are the initial outcomes of changes in the level of consciousness of both groups in the first, second, third and fourth weeks after the administration of the drug.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061634573N1
Registration date:2017-08-16, 1396/05/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-16, 1396/05/25
Registrant information
Name
Behrooz Zarasvand
Name of organization / entity
Ahvaz Jundishapoor University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3375 7137
Email address
zarasvand.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapoor University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2016-04-18, 1395/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Amantadin and placebo(Acetaminophen) on the level of consciousness in patients with traumatic brain injury with an average level of consciousness
Public title
The effect of Amantadin on the level of consciousness in patients with traumatic brain injury with an average level of consciousness on arrival at the Golestan hospital in 1395 and 1396
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion:level of consciousness between 9 and 13 ; arrived a day gavage ; absence of kidney damage and other diseases ; are not sensitive to amantadine ; no pregnancy, no injury ;having age between 18 to 60 -Exclusion criteria: expair patient during the study ; drug toxicity ; cardiac arrest ; respiratory and renal damage in patients; with surgical complications and seizure ; of clotting problems ; maxillofacial trauma
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Department of Development Research and Technological University Jundishapoor of Medical Sciences
Street address
Ahvaz University Jundishapoor of Medical Sciences- Department of Development Research and Technological - Ahvaz
City
Ahvaz
Postal code
1579461457
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
ir.ajums.Rec.1396.141
Health conditions studied
1
Description of health condition studied
Traumatic brain injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse brain injury
Primary outcomes
1
Description
Level of consciousness
Timepoint
after arrival at the unit-one week ،two weeks ، after starting the drug
Method of measurement
Glasgow Coma Scale
Secondary outcomes
empty
Intervention groups
1
Description
Drug therapy in the control group (Amantadine tablets 200 mg) and case group (Acetaminophen200)