The aim of this study is to assess the severity of the symptoms of the premenstrual syndrome and to compare the therapeutic effects of Omega-3 fatty acid and perforan on the symptoms of premenstrual syndrome. It was studied on three groups with 180 students of the dormitory of Isfahan University in Iran.
At first step, they filled a questionnaire about their symptoms for two menstrual cycles. Mild and moderate premenstrual syndrome, Regular 24-35 days menstrual cycles, lack of having mental illness and physical and endocrine disease or having allergy to fish or sunlight are some criteria for entering to this study. Unwillingness to continue the study and appearing any kind of disease in during of the study such as endocrine disease, appearing any complications or drug allergy, lack of taking drugs in the first cycle for one week frequently and lack of taking drugs for two days in second and third cycles are some criteria for stopping the study. The students of this study are divided randomly to three groups include of omega 3 fatty acid (1000 mg) group, perforan group (480 mg) and placebo control group. Every student in this study takes drugs during three subsequent cycles so that she takes two capsules daily in the first cycle for one month and in second and third cycles she takes them from eight days before menstruation to two days after it and records the severity of the symptoms of her menstruation in the questionnaire of the symptoms. The result of this Study for the students is the reduction of the severity of mental, physical and behavior symptoms of premenstrual syndrome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107262751N3
Registration date:2012-03-19, 1390/12/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-19, 1390/12/29
Registrant information
Name
Masoomeh Kheirkhah
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8247 1000
Email address
kheirkhah@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-12-31, 1390/10/10
Expected recruitment end date
2012-05-30, 1391/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 fatty acid and Perforan on severity of symptoms in premenstrual syndrome
Public title
Comparison of Perforan and omega-3 on severity of premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Regular menstrual cycles 24-35 days, 18-35 years of age and unmarried, non-psychotic mental illness, lack of physical illnesses including endocrine diseases known as non-hormonal drugs, anticoagulant, antidepressants, supplements and herbal medicine, not taking any medication for the treatment of premenstrual syndrome, No alcohol or drugs, sensitivity to the sun and sea food, relatives who died in the last 3 months, surgery in the last 3 months. Exclusion criteria: any disease endocrine disease during the study, having severe premenstrual syndrome, married during the study, Unwillingness to continue the study, If complications or allergic to a drug or other drug use, stop taking the medication for a week in regular cycles and irregular drug consumption in the second and third cycles for two days.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Scinces
Street address
5th Floor of the Central Organization, Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd
City
Tehran
Postal code
1417653761
Approval date
2011-06-18, 1390/03/28
Ethics committee reference number
1749
Health conditions studied
1
Description of health condition studied
Premenstural syndrome
ICD-10 code
F59
ICD-10 code description
Unspecified behavioural syndromes associated with physiological disturbances and physical factors
Primary outcomes
1
Description
Reduction in physical symptoms (headache, breast swelling and tenderness, back pain, abdominal pain, muscle pain, weight gain, swelling of extremities, nausea, diarrhea or constipation)
Timepoint
One month, two months, three months after intervention
Method of measurement
Questionnaire
2
Description
Reduction in behavioral symptoms (fatigue, lack of energy, insomnia, difficulty concentrating, increased appetite)
Timepoint
One month, two months, three months after intervention
Method of measurement
Questionnaire
3
Description
Reduction in mood symptoms (irritability and restlessness, anxiety and impatience, anger, depression and sadness, crying for no reason, feeling alone)
Timepoint
One month, two months, three months after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Side effects of drugs
Timepoint
Three months after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Placebo capsules, 1000 mg, 2 times a day, orally for 3 months
Category
Treatment - Drugs
2
Description
Perforun Capsules, 240 mg, 2 times a day, orally for 3 months
Category
Treatment - Drugs
3
Description
Fatty acid capsules three thousand milligrams, twice daily for 3 months, orally
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Esfahan non-medical students dormitories
Full name of responsible person
Kobra Abbasinya, Midwifery master of science student
Street address
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
5th Floor of the Central Organization, Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Masoomeh Kheirkhah
Position
University Lecturer, Master of Midwifery
Other areas of specialty/work
Street address
5th Floor of the Central Organization, Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 8163 3575
Fax
Email
kheirkhah@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)