This clinical trial is a study on women is referred to Taleghani Hospital of Arak. Random sample of 120 person, Which randomly and using form provisional diagnosis of premenstrual syndrome occurs (Wong-Baker faces pain rating scale (WBS).Inclusion criteria: Age 18-30 years, Regular menstrual periods with long intervals of 21-35 days, BMI:8/19-26, No smoking, Lack of contraceptive pills, The absence of Allergy to fish or fish oil or herbal medicines. Exclusion criteria: Self-medication, The study of non-compliance with medication orders. Selected individuals will be placed randomly in three groups. Group the first 14 days before the onset of menstruation, subsequent to menopause, daily A capsules 500 mg omega-3 and the second group during 14 days before the time of menarche until menopause, 30 drops of Oral drops of rose will be given .Third group as control and will not receive the drug. Patients in this group are not well-justified self-treatment and in this case will be excluded. Intervention will be conducted in three successive cycles. Form in the patient's symptoms can be completed on a daily basis. The index is calculated using SPSS software and t test Analysis was central and dispersion. The aim is to study the effect of treatment rose extracts and omega-3 can be proposed using these drugs improve quality of life in women with lower cost and reduced side effects.
General information
Acronym
PMS:Pre-Menstrual Syndrome
IRCT registration information
IRCT registration number:IRCT201108237405N1
Registration date:2012-05-09, 1391/02/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-09, 1391/02/20
Registrant information
Name
Dr Sanaz Mirzae
Name of organization / entity
Arak University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 0660
Email address
dr.smirzayi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University Of Medical Sciences
Expected recruitment start date
2012-04-08, 1391/01/20
Expected recruitment end date
2014-03-16, 1392/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of omega-3 and rose extract treatment of premenstrual syndrome in women with dysmenorrhea who referred to Taleghani Hospital, Arak
Public title
Comparison of the therapeotic effects of omega3 fatty acids and Rose damascena on premenstural syndrom
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 to 30 years old; regular menstrual periods with long intervals of 21-35 days; body mass index between 19.8 to 26; no history of smoking; not using contraceptive pills, anticonvulsants, antidepressants and vitamins during last 3 months; no history of mental illness and physical context (diabetes, hyperthyroidism and hypothyroidism, etc.); absence of symptoms such as tingling, Itching or abnormal vaginal discharge; no allergy to fish or fish oil or herbal medicines; no incident occurred in the past 6 months and diagnosis of premenstrual syndrome by using form syndrome diagnostic criteria for temporary.
Exclusion criteria: unwillingness to continue their treatment and non-compliance with medication orders during the study.
Age
From 18 years old to 30 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethic Committee Of Arak University Of Medical Sciences
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Postal code
3819693345
Approval date
2012-02-27, 1390/12/08
Ethics committee reference number
7-121-90
Health conditions studied
1
Description of health condition studied
Premenstrual Syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Pain Intensity
Timepoint
During The next 14 days before the time of menarche to menopause
In the second group during 14 days before the start of the next menstruation to end of menstruation, the daily will be 30 drops (15 drops twice a day) Rose Oral Drop (Barij Essence company)
Category
Treatment - Drugs
2
Description
In the first group during the 14 days before the start of the next menstruation to menopause, a daily 500 mg of omega 3(Blooms build Australia's brand, company Baryj Essence)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr Sanaz Mirzae
Street address
Taleghani Hospital Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr Saed Changizi Ashtiyani
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
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 Univesity of Medical Sciences
Full name of responsible person
Dr Sanaz Mirzae
Position
MD, Resident of Obstetrics And Gynecology
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
dr.smirzayi@arakmu.ac.ir
Web page address
www.portal.arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Taleghani Hospital
Full name of responsible person
Dr Mehri Jamilian
Position
Assistant Professor of Obstetrics and Gynecology
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@arakmu.ac.irmjamilian@yahoo.com
Web page address
www.portal.arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Sanaz Mirzae
Position
MD, Resident of Obstetrics and Gynecology
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
dr.smirzayi@arakmu.ac.ir
Web page address
www.portal.arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)