This was double-blinded clinical trial that was performed in dormators of students affiliated to Iiam University of Medical Science. The aim of study was to survay the effect of cinnamon and ibuprofen on primary dysmenorrhea in 114 female students during the year 2013.Inclusion criteria:Age range 18-130 years;presence of menstrual pains among recent 6 month;having regular menstrual cycles .Exclusion criteria: history of chronic diseases; history of abdomenal/ pelvic surgery; usage of oral contraceptive pills and herbal or drug allergy.
Each of participants evaluated for4 menstrual cycles. That in first cycle we take no intervention and the participant recorded its pain and nausea severity with VAS scale and pain duration with Cox Menstrual Scale , and a watch.also amount of beeding was measured with number of used pads.samples were selected by convenience method then participants randomly assigned to one of groups the Cinnamomum, ibuprofen or placebo. with onset of menstrual pain,In the experimental group two oral capsules of powdered cinnamon bark extract (420 mg capsules ) three times a day, in the placebo group two oral capsule containing starch three times a day and in the ibuprofen group two oral capsules 200 mg of Ibuprofen three times a day was used.Capsules shape and guidelines prescribed in the three groups were the same.in three groups, drugs were used during the first three days of each cycle for three consecutive monthsthe and questionnaire No:2 was filled.
General information
Acronym
Comparison Effect of Cinnamon Zeylanicum and Ibubrofen for Treatment of Primary Dysmenorrhea
IRCT registration information
IRCT registration number:IRCT2013122114668N2
Registration date:2015-01-09, 1393/10/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-09, 1393/10/19
Registrant information
Name
Molouk Jaafarpour
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7123
Email address
jaafarpour-m@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Ilam University of Medical Sciences
Expected recruitment start date
2012-12-12, 1391/09/22
Expected recruitment end date
2013-12-13, 1392/09/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Effect of Cinnamon Zeylanicum and Ibubrofen for Treatment of Primary Dysmenorrhea
Public title
Comparison Effect of Cinnamon Zeylanicum and Ibubrofen for Treatment of Primary Dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Age range 18-130 years;presence of menstrual pains among recent 6 month;having regular menstrual cycles .Exclusion criteria: history of chronic diseases; history of of abdomenal/ pelvic surgery; usage of oral contraceptive pills;herbal or drug allergy
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
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
Ilam University of Medical Sciences
Street address
Pajohesh Blvd, Banganjab, Ilam
City
Ilam
Postal code
Approval date
2012-12-12, 1391/09/22
Ethics committee reference number
EC/92/H/184
2
Ethics committee
Name of ethics committee
Ilam University of Medical Sciences
Street address
Pajohesh Blvd, Banganjab, Ilam
City
Ilam
Postal code
Approval date
2012-12-12, 1391/09/22
Ethics committee reference number
EC/92/H/184
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 1,2,3,4,8,16,24,48 and 72 hour after intervention
Method of measurement
VAS
Secondary outcomes
1
Description
duration of menstural pain
Timepoint
onset of pain to stop
Method of measurement
Cox Menstrual Scale
2
Description
amount of bleeding
Timepoint
duration first three days of menstural cycles
Method of measurement
number of used pads
3
Description
nausea severity
Timepoint
during first three days menstural cycles
Method of measurement
VAS
Intervention groups
1
Description
In the experimental group, two oral capsules of powdered cinnamon bark extract (420 mg capsule), three times a day during in the first three days of menstural cycle for three consecutive months was used.
Category
Treatment - Drugs
2
Description
In the Ibuprofen group , two oral capsules 200 mg of Ibuprofen three times a day during the first three days of each cycle for three consecutive months was used .
Category
Treatment - Drugs
3
Description
In the placebo group ,two oral capsules containing 420 mg starch three times a day in the first three days of each cycle for three consecutive months was used .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The dormatorses of students affiliated to Ilam University of Medical Science
Full name of responsible person
Molouk Jaafarpour
Street address
Pajohesh Blvd, Banganjab, Ilam
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
Pajohesh Blvd, 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
Molouk Jaafarpour
Position
Faculty, lecturer
Other areas of specialty/work
Street address
Pajohesh Blvd, Banganjab
City
Ilam
Postal code
Phone
+98 84 1222 7123
Fax
Email
jaafarpour-@medilam.ac.ir jaafarpourm@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Molouk Jaafarpour
Position
Faculty membe, lecturer
Other areas of specialty/work
Street address
Pajohesh Blvd, Banganjab
City
Ilam
Postal code
Phone
+98 84 1222 7123
Fax
Email
jaafarpour-@medilam.ac.ir
jaafarpourm@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Molouk Jaafarpour
Position
Faculty membe, lecturer
Other areas of specialty/work
Street address
Pajohesh Blvd, Banganjab
City
Ilam
Postal code
Phone
+98 84 1222 7123
Fax
Email
jaafarpour-@medilam.ac.irjaafarpourm@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)