It is a double blind clinical trial to assess the efficacy of vitamin E and omega-3 in the treatment of primary dysmenorrheal. We will recruit 80 patients suffering from primary dysmenorrhea and allocate them into two matched groups randomly.40 patients in group A are treated with 400mg of vitamin E and the other 40 patients (group B) are treated with omega-3. Intervention is continued for 2 month in both groups. The main outcomes are pain according to visual analogue scale (VAS) and duration of pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009044686N1
Registration date:2011-01-10, 1389/10/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-10, 1389/10/20
Registrant information
Name
Mehri Jamilian
Name of organization / entity
School of Medicine, Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 0660
Email address
mjamilian@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-01-20, 1389/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of omega-3 with Vitamin E on the treatment of primary dysmenorrhea
Public title
Comparing the effect of omega-3 with Vitamin E on the treatment of primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: People who have primary dysmenorrheal and use irregular NSAIDS and OCP. Exclusion criteria: Patients with secondary dysmenorrhea (endometriosis, adenomyosis, leiomyoma, uterine anomaly, Endometrial Polyps, ovarian cyst).
Age
From 15 years old to 20 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
School of Medicine, Arak University of Medical Sciences
City
Arak
Postal code
3816149369
Approval date
2011-02-28, 1389/12/09
Ethics committee reference number
4-72-88
Health conditions studied
1
Description of health condition studied
Dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
pain duration
Timepoint
at first and two months after intervention
Method of measurement
based on hours
2
Description
pain intensity
Timepoint
at first and 2 months after intevention
Method of measurement
Based on the VAS pain intensity
Secondary outcomes
empty
Intervention groups
1
Description
Vitamin-E, 400 units, every other day for 2 months
Category
Treatment - Drugs
2
Description
Salmon fish oil, 500 mg (containing 180 mg of EPA and DHA 129 gram), daily for 2 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
One and two zones in high school education Arak
Full name of responsible person
Dr Mehri Jamilian (Gyn Specialist)
Street address
Taleghani Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Saeid Ashtiyani
Street address
Taleghani Hospital
City
Arak
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University Of Medical Sciences
Full name of responsible person
Dr Mehri Jamilian
Position
Specialist Obstetrics & Gynecology /Faculty Member
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arak
Postal code
3816149369
Phone
+98 86 1278 0660
Fax
+98 86 1278 8301
Email
mjamilian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr Mehri Jamilian
Position
Specialist Obstetrics & Gynecology Faculty Member University of Medical Sciences
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arak
Postal code
3816149369
Phone
+98 86 1278 0660
Fax
+98 86 1278 8301
Email
mjamilian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr Mehri Jamilian
Position
Specialist Obstetrics & GynecologyFaculty member Danshkah medical
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arak
Postal code
3816149369
Phone
+98 86 1278 0660
Fax
+98 86 1278 8301
Email
mjamilian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)