This is double-blinded crossing trial that will be perform in two dormatorse(khayam and kawsar) of students affiliated to ilam university of medical science. The aim of study is to survay the effect of celecoxib and iboprofen on primary dysmenorrhea in 80 girl students. Inclusion criteria including age 18-22 y-o, presence of menstrual pains among recent 6 month. Exclusion criteria including history of abdomenal/ pelvic surgery and usage of OCPs. The samples will be select by convenience method then assigned to two groups of celecoxib – ibuprofen and celecoxib – ibuprofen. Each of participants evaluated for 3 menstrual cycles. That in first we take no intervention and the participant should record its pain severity and duration with Andrish-Melisum, VAS scale and a watch. In one of the groups in 2th cycle with onset of menstrual pain, participant use 1 tab of celecoxib 200 mg every 12h and in 3th cycle she should a tab of ibuprofen 400mg every 6-8h then she fill the questionnaire No:2. In another group in 2th cycle with onset of pain the participants use 1 tab of ibuprofen 400mg every 6-8h and in 3th cycle 1 tab of celecoxib 200 mg every 12h, the questionnaire No:2 will be filled.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304096790N4
Registration date:2013-05-22, 1392/03/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-22, 1392/03/01
Registrant information
Name
Zainab Suhrabi
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 1222 7123
Email address
suhrabi-z@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of reserch and technology at ilam university of medical sciences
Expected recruitment start date
2013-04-25, 1392/02/05
Expected recruitment end date
2013-07-27, 1392/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison The Effect Of Celecoxib And Ibuprofen On The treatment of Primary Dysmenorrhea on Students of Ilam Univercity of Medical Sciences
Public title
Comparison The Effect Of Celecoxib And Ibuprofen On The treatment of Primary Dysmenorrhea on Students of Ilam Univercity of Medical Sciences
Purpose
Treatment
Inclusion/Exclusion criteria
This is double-blinded crossing trial that will be perform in two dormatorse(khayam and kawsar) of students affiliated to ilam university of medical science. The aim of study is to survay the effect of celecoxib and iboprofen on primary dysmenorrhea in 80 girl students. Inclusion criteria including age 18-22 y-o, presence of menstrual pains among recent 6 month. Exclusion criteria including history of abdomenal/ pelvic surgery and usage of OCPs. The samples will be select by convenience method then assigned to two groups of celecoxib – ibuprofen and celecoxib – ibuprofen. Each of participants evaluated for 3 menstrual cycles. That in first we take no intervention and the participant should record its pain severity and duration with Andrish-Melisum, VAS scale and a watch. In one of the groups in 2th cycle with onset of menstrual pain, participant use 1 tab of celecoxib 200 mg every 12h and in 3th cycle she should a tab of ibuprofen 400mg every 6-8h then she fill the questionnaire No:2. In another group in 2th cycle with onset of pain the participants use 1 tab of ibuprofen 400mg every 6-8h and in 3th cycle 1 tab of celecoxib 200 mg every 12h, the questionnaire No:2 will be filled.
Age
From 18 years old to 22 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ilam university of medical sciences
Street address
banganjab- pajohesh Blvd.
City
Ilam
Postal code
Approval date
2013-03-02, 1391/12/12
Ethics committee reference number
162/52/22
Health conditions studied
1
Description of health condition studied
Dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
primary dysmenorrhea
Primary outcomes
1
Description
Intensity of menstural pain
Timepoint
befor and 1,2,3,4,6,8,12,24,48 and 72 hour after intervention
Method of measurement
VAS scale
2
Description
duration of menstural pain
Timepoint
onset of pain to stop
Method of measurement
watch
Secondary outcomes
empty
Intervention groups
1
Description
In one of the groups in 2th cycle with onset of menstrual pain, participant use 1 tab of celecoxib 200 mg every 12h and in 3th cycle she should a tab of ibuprofen 400mg every 6-8h then she fill the questionnaire No:2
Category
Treatment - Drugs
2
Description
In another group in 2th cycle with onset of pain the participants use 1 tab of ibuprofen 400mg every 6-8h and in 3th cycle 1 tab of celecoxib 200 mg every 12h, the questionnaire No:2 will be filled.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
two dormatorse(khayam and kawsar) of students affiliated to ilam university of medical science
Full name of responsible person
Street address
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam university of medical sciences
Full name of responsible person
Dr.Morovat Taherikalani
Street address
banganjab- Deputy of reserch and technology
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam university of medical sciences
Full name of responsible person
Zainab suhrabi
Position
Faculty member- lecturer
Other areas of specialty/work
Street address
banganjab- Pajohesh Blvd.
City
Ilam
Postal code
Phone
+98 84 1222 7123
Fax
Email
suhrabi2007@yahoo.comsuhrabi-z@medilam.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam university of medical sciences
Full name of responsible person
Zainab suhrabi
Position
MS
Other areas of specialty/work
Street address
Banganjab- Pajohesh Blvd.
City
Ilam
Postal code
Phone
+98 84 1222 7123
Fax
Email
suhrabi2007@yahoo.comsuhrabi-z@medilam.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ilam university of medical sciences
Full name of responsible person
Zainab suhrabi
Position
Faculty member- lecturer
Other areas of specialty/work
Street address
Banganjab- Pajihesh Blvd.
City
Ilam
Postal code
Phone
+84 12227123
Fax
Email
suhrabi2007@yahoo.comsuhrabi-z@medilam.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)