Comparing the analgesic effect of extra virgin olive oil and ibuprofen for primary dysmenorrhea in students residing in dormitories of Borujerd islamic azad university: A randomized, Cross-Over clinical trial
Objective: The aim of this study was to compare the analgesic effect of extra virgin olive oil with ibuprofen on pain relief in primary dysmenorrhea.
Design: The present study was a cross-over, randomized clinical trial.
Setting and conduct: The study was conducted at Borujerd islamic azad University Dormitory.
Participants including major eligibility criteria: Sixty 17 t0 30 years old students with moderate to severe primary dysmenorrhea using MC Gill pain scale were selected to participate in this study. Based on random numbers table, the samples were equally divided into two groups.
Intervention: The participants in the first group took 25 cc of extra virgin oil daily, (two weeks before menstruation until two months after menstrual cycle for two consecutive cycles). After 3 weeks washed out period, they use ibuprofen 400 mg three times a day in the 3 first days of menstruation. alternative was used for the second group. A self-reported checklist was used to collect information on the number of sedative drugs and condition of menstrual. Also visual analog scale was used to determine severity of pain.
Main outcome variable: Severity of primary dysmenorrhea and the other menstruation problems were assessed after 4 mensturation periods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013051110804N2
Registration date:2013-07-23, 1392/05/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-23, 1392/05/01
Registrant information
Name
Marzieh Araban
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
تهران
Email address
m.araban@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Islamic azad university, Borujerd branch
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2011-03-03, 1389/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the analgesic effect of extra virgin olive oil and ibuprofen for primary dysmenorrhea in students residing in dormitories of Borujerd islamic azad university: A randomized, Cross-Over clinical trial
Public title
Comparing the analgesic effect of extra virgin olive oil and ibuprofen for primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Not being married, 17 to 30 years old; living in Islamic Azad university Borujerd branch dormitory; having score 4 to 10 for dysmenorrhea according to pain scale; having regular menstrual periods between 21 to 35 days, no history of myoma, pelvic tumor, endometriosis and pelvic inflammatory disease; no taking oral particular drug, no history of allergy to herbal drugs. Exclusion criteria: allergy to olive oil or non-steroidal anti inflammatory drugs;taking inappropriate dosage and forgetting the time table.
Age
From 17 years old to 30 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Islamic azad university, Borujerd branch
4 menstrual cycles, one cycle before the study and 2 cycles during the study after using extra virgine oil and 2 cycles after taking ibuprofen
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
Nausea
Timepoint
Before and after the treatment
Method of measurement
Questionnaire
2
Description
Diarrhea
Timepoint
Before and after the treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
First treatment/ control group:taking daily 25 cc of extra virgin olive oil for 2 months, Then ibuprofen 400 mg, three times a day for 2 cycles during the 3 first days of menstruation.
Category
Treatment - Drugs
2
Description
The second treatment/ control group: taking ibuprofen 400 mg three times a day during first 3 days of menstruation, Then, taking daily 25 cc of extra virgin olive oil, for 2 menstrual cycles.