To determine the effect of vitamin E and Evening primrose oil therapy in the treatment of premenstrual syndrom. Design: Double blinded randomized clinical trials. 70 health connectors who eligible for inclusion criteria will be recruited to this study. Thease people will randomly divided to two groups.
Intervention: The intervention group for two consecutive cycles, at least 14 days before menstruation, will receive three capsules of Evening primrose oil therapy (per capsule 1000 mg) in 3 dose daily. Control: In control group one capsule of Vitamin E 400 UI in luteal phase of cycle will use daily. Primary outcome:physical symptom of pre menstrual syndrom. Secondary outcome: mental symptom of premenstrual syndrom.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061313405N2
Registration date:2014-01-06, 1392/10/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-06, 1392/10/16
Registrant information
Name
Seyyedeh Zahra Masoumi
Name of organization / entity
Hamedan University of Medical Sciences, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0150
Email address
zahra.masoomi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Evening prime rose oil and vitamin E on reduction of symptoms of
premenstrual syndrom.
Public title
Comparison of Evening prime rose oil and vitamin E on reduction of symptom of premenstrual syndrom.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: a) Women in age between 18-30 years old; b) Having regular menstrual cycles every 35-24 days; c) Lack of physical or medication illness; d) No history of mental illness and depression; e) lack of antidepressant use in the past months f) Suffering from premenstrual syndrom. Exclusion study: a) Any use of hormonal and vitamin drugs or contraceptive pills; b) Experience of the spiritual crisis or death of a family member or surgery in the last three months ago.
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:
70
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 Hamedan University of Medical Sciences
Street address
Vice chancellor for research and technology,Hamedan University of Medical Sciences,Fahmideh Ave,Hamedan
City
Hamedan
Postal code
6517838695
Approval date
2013-05-05, 1392/02/15
Ethics committee reference number
16/35/9/262/پ/د
Health conditions studied
1
Description of health condition studied
Pre menstrual syndrom
ICD-10 code
F39
ICD-10 code description
Unspecified mood [affective] disorder
Primary outcomes
1
Description
physical symptom of pre menstrual syndrom.
Timepoint
Before intervention- immediately after intervention- 2 months after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
mental symptom of pre menstrual syndrom.
Timepoint
Before intervention-immediatly after intervention-2 months after intervention
Method of measurement
A questionnaire based on DSM-IV research criteria and demographic questionnaire.
Intervention groups
1
Description
The intervention group for two consecutive cycles, at least 14 days before menstruation, will receive three capsules of Evening primrose oil therapy (per capsule 1000 mg) in 3 dose daily and in group II (n = 35) one capsule of Vitamin E 400 UI daily in luteal phase of cycle will use.
Category
Treatment - Drugs
2
Description
In control group one capsule of Vitamin E 400 UI daily that similar to prime rose oils capsules in luteal phase of cycle for two months will use.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein health center of Hamedan
Full name of responsible person
Zahra Shojaee
Street address
2nd station,Behind of Bazare Rooz,Khezr,Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research the Technology, Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeed Bashiriyan
Street address
Vice chancellor for research and technology,Hamedan university of Medical Sciences,Fahmideh Ave,Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research the Technology, Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Seyyedeh Zahra Masoumi
Position
Instrucror
Other areas of specialty/work
Street address
School of nursing and midwifery,Hamedan University of Medical Sciences, Fahmideh Ave,Hamedan
City
Hamedan
Postal code
6516845977
Phone
+98 81 1838 0150
Fax
+98 81 1838 0447
Email
zahramid2001@yahoo.com; zahra.masoomi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyyedeh Zahra Masoumi
Position
Instructor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamedan University of Medical Sciences,Fahmideh Ave,Hamedan
City
Hamedan
Postal code
6516845977
Phone
+98 81 1838 0150
Fax
+98 81 1838 0447
Email
zahramid2001@yahoo.com; zahra.masoomi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyyedeh Zahra Masoumi
Position
Instructor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamedan university of Medical Sciences,Fahmideh Ave,Hamedan
City
Hamedan
Postal code
6516845977
Phone
+98 81 1838 0150
Fax
+98 81 1838 0447
Email
zahramid2001@yahoo.com; zahra.masoomi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)