Premenstrual Syndrome Symptoms of a set of physical, psychological, emotional and behavioral changes that in the luteal phase of the menstrual period occurs. Premenstrual syndrome, impaired communication, disrupting normal activity and sedentary. The aim of this study is to evaluate the effectiveness calcium supplement on premenstrual syndrome of Female students in Hamadan university of medical sciences. This clinical trial study will carry out in sixty four women with premenstrual syndrome in Hamadam university of medical sciences, Hamadan, Iran. Witten informed consent will obtain from all participants. The participants will randomly select to one of two oral treatments groups: Calcium (500mg/day) or Placebo. Demographic Questionnaire and the standard provisional diagnosis of menstruation and premenstrual syndrome, derived from the DSM-IV, is used. Severity of premenstrual syndrome will compare the case and control groups before and after treatment intervention end of two months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309296888N4
Registration date:2013-12-20, 1392/09/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-20, 1392/09/29
Registrant information
Name
Fatemeh Shobeiri
Name of organization / entity
Hamadan Universiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
shobeiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences, Department of Research and Technology
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-12-20, 1393/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Calcium Supplementation on Premenstrual Syndrome of Female students
Public title
The Effect of Calcium Supplementation on Premenstrual Syndrome of Female students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Student; Having premenstrual syndrom; Lack of alleregy to drugs, Exclusion criteria: Women with age below 17 and above 44 years; Pregnancy; Alleregy to drugs
Age
From 17 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Street address
Fahmodeh street, Hamadan Hamadan University of Medical Sciences, Department of Research and Technology
City
Hamadan
Postal code
Approval date
2013-07-24, 1392/05/02
Ethics committee reference number
1345
Health conditions studied
1
Description of health condition studied
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
ICD-10 code
R40-R46
ICD-10 code description
Symptoms and signs involving cognition, perception, emotional state and behaviour
Primary outcomes
1
Description
Premenstrual syndrome
Timepoint
Two months
Method of measurement
Questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Prescription oral Calcium (500 mg/daily) for two months.
Category
Treatment - Drugs
2
Description
Control group: Prescription Placebo for two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan University of Medical Sciences
Full name of responsible person
ّFatemeh Shobeiri
Street address
Fahmodeh street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences, Department of Research and Technology (Prim
Full name of responsible person
saiid Bashirian
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Department of Research and Technology (Primary sponsor)
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences, Department of Research and Technology (Prim
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
Hamadan University of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Associate professor, Ph.D. of Maternal and child Health
Other areas of specialty/work
Street address
Fahmodeh street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1838 0150
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Associated professor, Ph.D. of Maternal and child Health
Other areas of specialty/work
Street address
Fahmodeh street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1838 0150
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Associate professor, Ph.D. of Maternal and child Health
Other areas of specialty/work
Street address
Fahmodeh street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1838 0150
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)