Protocol summary

Summary
After obtaining written informed consent from the patient's family, and getting an approval from Ethics committee of Ahvaz Jundishapur University of Medical Sciences, 40 head trauma patients will take part in a single-blind prospective, randomized study to comparative efficacy of Cyproheptadine and Baclofen on spasticity in patients with head trauma. Inclusion criteria: patients with diffuse axonal injury without chronic hepatic or renal disease; 15 to 60 years old. Exclusion criteria: changing in treatment plan like surgery; drug reactions; drug side effects. Patients will be randomly allocated into two groups according to table of random numbers. Groups "one" and "two" will receive oral Cyproheptadine 2 mg/kg with oral Baclofen 25 mg/kg and oral Baclofen 25 mg/kg every eight hours for fifteen days, respectively. Both groups of patients are unaware of type of prescription drugs. Spasticity in patients in 1, 3, 6, 9, 12, 15 days, according to Modified Ashworth Scale is measured. Alaninetransaminase, Aspartate Aminotransferase, and Alkaline Phosphatase weekly, and Blood Urea Nitrogen, and Creatinine daily will measure.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014041112777N1
Registration date: 2014-05-13, 1393/02/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-05-13, 1393/02/23
Registrant information
Name
Soheil Fallahpour
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3032
Email address
fallahpour.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Expected recruitment start date
2014-08-22, 1393/05/31
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of Cyproheptadine and Baclofen on spasticity in patients with head trauma
Public title
Comparative efficacy of Cyproheptadine and Baclofen on spasticity in patients with head trauma
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with diffuse axonal injury without chronic hepatic or renal disease; 15 to 60 years old. Exclusion criteria: Changing in treatment plan like surgery; drug reactions; drug side effects.
Age
From 15 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
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 Ahvaz Jundishapur University of Medical Sciences
Street address
No. 21, Ave. 1, Golestan Blvd.
City
Ahvaz
Postal code
61357-15794
Approval date
2012-06-09, 1391/03/20
Ethics committee reference number
ETH-490

Health conditions studied

1

Description of health condition studied
Head Trauma
ICD-10 code
S07
ICD-10 code description
Multiple superficial injuries of head

Primary outcomes

1

Description
Spasticity
Timepoint
1, 3, 6, 9, 12, 15 days
Method of measurement
Modified Ashworth Scale

Secondary outcomes

1

Description
Alanine Transaminase (ALT)
Timepoint
Weekly
Method of measurement
U/ml

2

Description
Blood Urea Nitrogen(BUN)
Timepoint
Daily
Method of measurement
Mg/dl

3

Description
Aspartate Amino Transferase(AST)
Timepoint
Weekly
Method of measurement
U/ml

4

Description
Alkaline Phosphatase(ALP)
Timepoint
Weekly
Method of measurement
U/ml

5

Description
Creatinine
Timepoint
Daily
Method of measurement
Mg/dl

Intervention groups

1

Description
Drugs: 1- Cyproheptadine: Dose: 2 mg/kg Number of using:Forty five times Factory name: Jalinus Country's Name: Iran Location prescribed: Oral Administration time: Every eight hours 2- Baclofen: Dose: 25 mg/kg Number of using: Forty five times Factory name: Mylan Country's Name: England Location prescribed: Oral Administration time: Every eight hours
Category
Treatment - Drugs

2

Description
Baclofen: Dose: 25 mg/kg Number of using: Forty five times Factory name: Mylan Country's Name: England Location prescribed: Oral Administration time: Every eight hours
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Educational Hospital
Full name of responsible person
Dr. Saleh Rasras
Street address
No. 307, Kokab Street, Masters Alley, Golestan Blvd.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
No. 21, Ave. 1, Golestan Blvd.
City
Ahvaz
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, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Soheil Fallahpour
Position
Resident of Neurosurgery
Other areas of specialty/work
Street address
No. 12, Enghelab Chamber, Golestan Blvd.
City
Ahvaz
Postal code
Phone
+98 61 1374 3032
Fax
Email
Fallahpour.s@ ajums.ac.ir, Fatahi.m@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Soheil Fallahpour
Position
Resident of Neurosurgery
Other areas of specialty/work
Street address
No. 12, Enghelab Chamber, Golestan Blvd.
City
Ahvaz
Postal code
Phone
+98 61 1374 3032
Fax
Email
Fallahpour.s@ ajums.ac.ir, Fatahi.m@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Soheil Fallahpour
Position
Resident of Neurosurgery
Other areas of specialty/work
Street address
No. 12, Enghelab Chamber, Golestan Blvd.
City
Ahvaz
Postal code
Phone
+98 61 1374 3032
Fax
Email
Fallahpour.s@ajums.ac.ir, fatahi.m@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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