Prednisolone-Sodium Valproate has not been extensively abused by the patients as a pain reliever medication in treating headaches The aim of study is analyzing the efficacy of Prednisolone-Sodium Valproate and comparing it with Prednisolone-Nortriptyline in reduction of headache severity during the withdrawal period of the medicine. The study uses a randomized, double-blind clinical trial methodology on patients of a private clinic in Babol during in 2016 between 15 to 60 year old patients, who are suffering from headache more than 15 days in month, are enrolled in the trial. Subjects are divided into two random groups. Both groups are prescribed with Prednisolone 50mg/1kg for 5 days. Additionally, a random group receive Sodium Valproate 200mg every 12 hours, and the other group is given Nortriptyline 10mg every 24 hours, for two months. The factors such as days of headache, headache severity, duration of headache, taking other pain relievers due to severe pain, and drugs side effects are investigated. Visual analog scale (VAS) is used to determine the severity of headaches.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060718479N1
Registration date:2016-07-08, 1395/04/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-08, 1395/04/18
Registrant information
Name
Sohrab Kazemi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 4308
Email address
s.kazemi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Medication Overuse Headache and Compression Between the Effect of Perdnisolone - nortyliptilin and prednisolone- sodium valproate
Public title
Treatment of stage withdrawal headaches caused by abuse drugs.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age between 15-60 years; daily headache present on 15day/month; regular overuse for >3 month of 1 or more acute/symptomatic treatment drugs; headache has developed during medication overuse.
Exclusion criteria:
Age<15 years, severe systemic pathologic associated to chronic headache; major psychiatric disorder such as major depression; hypochondriasis; Contraindication or sensitivity to drugs use in study; pregnancy or lactation
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences, Deputy of research & technology
Street address
University of Medical Sciences, Ganjafroz Street
City
Babol
Postal code
Approval date
2013-11-09, 1392/08/18
Ethics committee reference number
3326
Health conditions studied
1
Description of health condition studied
Headache caused by drug abuse
ICD-10 code
G44.4
ICD-10 code description
Drug-induced headache
Primary outcomes
1
Description
Number of headache attack s
Timepoint
Before treatment, after 2 month of treatment
Method of measurement
number
2
Description
Remission headache
Timepoint
Before treatment, after 2 month of treatment
Method of measurement
Qualitative and based on the positive or negative.
3
Description
The days of headache
Timepoint
Before treatment, after 2 month of treatment
Method of measurement
day
Secondary outcomes
1
Description
Drug side effect
Timepoint
At the start of the intervention, after 2 month of treatment
Method of measurement
questionnaire
Intervention groups
1
Description
Prednisolone 50mg/1kg for 5 days. Additionally, a random group will receive Nortriptyline 10mg every 24 hours
Category
Treatment - Drugs
2
Description
Prednisolone 50mg/1kg for 5 days. Additionally, a random group will receive Sodium Valproate 200mg every 12 hours for 2 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Specialized Clinic.
Full name of responsible person
Ebrahim Valinejad shubi
Street address
Babol University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Babol University of Medical Sciences
Full name of responsible person
Ali Akbar Moghadamnia
Street address
Babol University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
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 of Babol 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
Babol University of Medical Sciences
Full name of responsible person
Ali Akbar Moghadamnia
Position
Pharmacology Profesor
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Postal code
4717641367
Phone
+98 11 3219 7667
Fax
Email
moghadamnia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Akbar Moghadamnia
Position
Pharmacology profesor
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Postal code
4717641367
Phone
+98 11 3219 7667
Fax
Email
moghadamnia@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Shabnam Ashofteh
Position
MD
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Postal code
Phone
+98 11 3219 7667
Fax
Email
shabnam.ir@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)