object: Effect of flaxseed oil supplement on pain severity and systemic symptoms of primary dysmenorrhea in girl Students. In this 2 phase double blind clinical trial 60 female students would be randomly allocated to the supplement or placebo groups using random number tables. neither the participants nor administrator of the treatment know which capsules are being received.
Inclusion criteria: single women between 18 and 25years; regular menstrual cycles; moderate or severe of primary dysmenorrhea was assessed with verbal multidimensional scoring system; body mass index range 18.5 to 24.9.
Exclusion criteria: stressors in the past three months; History of surgery in abdomen or pelvic area.
For the subjects in the intervention group, 1000 mg capsules of flaxseed oil was provided to consume in three times a day for 2 months. On the other hand, the control group received on placebo capsule that was similar the color and shape of flaxseed oil but included 1000 mg Paraffin, three times a day for 2 months.
The questionnaires had given to participants until registering the pain intensity and systemic symptoms(sach as nausea, vomiting, diarrhea, headache, fatigue and backache) in the related forms after treatment during each menstruation period and to deliver to researcher after the end of period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030810181N9
Registration date:2017-05-26, 1396/03/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-26, 1396/03/05
Registrant information
Name
Fatemeh Heidari
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8255
Email address
haidari-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-05-15, 1396/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of flaxseed oil supplement on pain severity and systemic symptoms of primary dysmenorrhea in girl Students
Public title
Effect of flaxseed oil on menstrual pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: single women between 18 and 25years; regular menstrual cycles; moderate or severe of primary dysmenorrhea was assessed with verbal multidimensional scoring system; body mass index between18.5 and 24.9
Exclusion criteria: stressors in the past three months; taking medications such as hormonal contraceptive; secondary dysmenorrhea; History of surgery in abdomen or pelvic area
Age
From 18 years old to 25 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this double blind study neither the patients nor administering the treatment know which capsules are being received.The participants woul be randomly allocated to the supplement or placebo groups using random number tables.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Golestan Ave, Ahvaz Jundishapur University of Medical Science, Ahvaz
City
Ahvaz
Postal code
1579461357
Approval date
2017-01-07, 1395/10/18
Ethics committee reference number
ir.ajums.REC.1395.709
Health conditions studied
1
Description of health condition studied
primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
primary dysmenorrhea
Primary outcomes
1
Description
pain intensity
Timepoint
one cycle before and two cycles after intervention