In this study is designed for comparison of two drugs, Ibo profen and Acetaminophen, Aspirin, Caffeine,(AAC) in pain relieve in acute phase of migraine headaches. Sixty patients with migraine headaches according to international headache society criteria(IHS) who attended for treatment of their pain are selected and the study aims and procedures are described for them perfectly. Patients are between twenty to forty-five years old and all have informed consent for the use of analgesics.Patients with gastrointestinal problems, other types of headaches such as cluster or tension,...,other chronic pains, chronic use of opium or analgesics, past history of psychiatric problems and allergy to drugs are not permitted. All patients take Ibuprofen 800 mg (two tablets of 400 mg) and 2 AAC tablets in four separate attacks of headache. Pain in these patients is measured with point box scale 11(BS11) before and then 2 and 6 hours after use of drugs in each attack. All patients in first two attack take iboprofen and take AAC in the third and fourth attack. Patients and the persons who give the drugs to patients blinded to drug type. All patients are evaluated with 6-points behavioral rating scale (BRS-6) which is a clinical scale for pain evaluation only one time six hours after each drug separately. All data are analyzed statically for comparison of effects between to drugs. All patients have written informed consent by supervision of ethical committee of shahed university and can leave the study each time during it.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052930680N4
Registration date:2017-10-02, 1396/07/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-02, 1396/07/10
Registrant information
Name
Siamak Afshinmajd
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 9438
Email address
afshin@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Department of Shahed University. This Is a Dissertation in General Medicine.
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2017-12-20, 1396/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effects of Combined Drugs Acetaminophen,Aspirin,Caffeine With Ibo Profen On Acute Attacks of Migraine Headaches
Public title
The Effect Of Combination of Drugs Acetaminophen, Aspirin, Caffeine (AAC) on Migraine Headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria;
Migraine headache according to criteria of international headache society
Informed consent of patients for use of analgesics in acute attack of headaches
Age between twenty to forty-five years old
Exclusion Criteria;
Gastro intestinal problems
Other types of headaches such as cluster,tension,....
Chronic pain in other parts of body
Chronic use of analgesics or opium
Past history of psychiatric problems
Allergy to drugs which are used in the study
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Shahed University
Street address
Entrance of Tehran - Qom highway
City
Tehran
Postal code
Approval date
2017-04-05, 1396/01/16
Ethics committee reference number
IR.SHAHED.REC.1395.235
Health conditions studied
1
Description of health condition studied
Headache
ICD-10 code
G-43
ICD-10 code description
MIGRAINE
Primary outcomes
1
Description
Pain
Timepoint
Before, Two and six hours after taking drugs each time and four time for each patient
Method of measurement
BS-11/11-Point box scale/
2
Description
Pain
Timepoint
six hours after taking each drug one time and two time for each patient
Method of measurement
BRS-6/6-point behavioral rating scale
Secondary outcomes
1
Description
Urticaria,Pruritus and redness of skin
Timepoint
Instantly after alarm of the patient
Method of measurement
Observation and consultation with proper specialist
Intervention groups
1
Description
Both test and control are the same .Each migrainous patients takes drugs for four times .At first and second attack iboprofen and acetaminophen,aspirin and caffeine for 3rd and 4th attacks and each time patients are evaluated with standard scales for pain
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini Hospital
Full name of responsible person
Siamak Afshinmajd
Street address
Keshavarz Bld, Italia Street, tehran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Department, Shahed University
Full name of responsible person
Zahra Kiasalari. Head of Research Department.
Street address
Entrance of Tehran -Qom Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department, Shahed University
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
Medicine Faculty ,Shahed University
Full name of responsible person
Siamak Afshinmajd
Position
Associate Professor of Neurology
Other areas of specialty/work
Street address
Entrance of Tehran -Qom express way, Shahed University
City
Tehran
Postal code
Phone
+98 21 5121 3092
Fax
Email
afshin@shahed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Mostafa Khomeini Hospital
Full name of responsible person
Siamak Afshinmajd
Position
Associate Professor of Neurology
Other areas of specialty/work
Street address
Keshavarz Bld, Italia Street, Tehran.
City
Tehran
Postal code
Phone
+98 21 8896 9438
Fax
Email
safshinmajd@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Mostafa Khomeini Hospital
Full name of responsible person
Siamak Afshinmajd
Position
Associate Professor of Neurology
Other areas of specialty/work
Street address
Keshavarz Bld, Italia Street, Tehran
City
Tehran
Postal code
Phone
Fax
Email
safshinmajd@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)