This double blind clinical trial performs on 76 students of Hamedan University of Medical Sciences with inclusion criteria: regular menstrual periods with 21-35 days cycles and 3-10 days bleeding period; no known psychological diseases; no physical diseases such as diabetes, seizure disorders, hypothyroidism and so on; no death of close relatives, divorce or other adverse events in the last three months; no Antidepressants, hormonal contraceptives, medroxyprogesterone acetate, and vitamins taken in the past three months and exclusion criteria: pregnancy; incidents like the death of close relatives, divorce, and other adverse events. Subjects take tablets of calcium and vitamin B6 or vitamin B6 two times daily from day 16 of menstrual cycle until day 5 of menstrual cycle. The present study examines the effect of combined use of Calcium and Vitamin B6 on the symptoms of premenstrual syndrome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070313405N3
Registration date:2014-11-12, 1393/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-12, 1393/08/21
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 of Hamedan University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of combined use of Calcium and Vitamin B6 on symptoms of premenstrual syndrome
Public title
Effect of Combined Use of Calcium and Vitamin B6 on premenstrual Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: regular menstrual periods with 21-35 days cycles and 3-10 days bleeding period; no known psychological diseases; no physical diseases such as diabetes, seizure disorders, hypothyroidism and so on; no Surgery, death of close relatives; divorce or other adverse events in the last three months; no Antidepressants, hormonal contraceptives, medroxyprogesterone acetate, and vitamins taken in the past three months; Exclusion criteria: pregnancy; incidents like the death of close relatives; divorce; and other adverse events.
Age
From 20 years old to 30 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
76
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
Ethic Committee of Hamedan University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Hamedan University of Medical Sciences, Shahid Fahmideh Avenue, Hamedan
City
Hamedan
Postal code
6517838695
Approval date
2014-07-21, 1393/04/30
Ethics committee reference number
0097144046691
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
Severity of Premenstrual Syndrome
Timepoint
Eight weeks before treatment, Eight weeks after treatment
Method of measurement
Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vitamin B6 combined with Calcium tablets, two times a day for two months.
Category
Treatment - Drugs
2
Description
Control group: Vitamin B6 tablet, two times a day for two consecutive months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Ali Ataei
Street address
Vice Chancellor of Research and Technology, Hamedan University of Medical Sciences, Shahid Fahmideh Avenue, Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research of Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashiriyan
Street address
Vice Chancellor of Research and Technology, Hamedan University of Medical Sciences, Shahid Fahmideh Avenue, 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 of Research of 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
Instructor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamedan University of Medical Sciences, Shahid Fahmideh Avenue, Hamedan
City
Hamedan
Postal code
6516845977
Phone
+98 81 1838 0150
Fax
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, Shahid Fahmideh Avenue, Hamedan
City
Hamedan
Postal code
6516845977
Phone
+98 81 1838 0150
Fax
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, Shahid Fahmideh Avenue, Hamedan
City
Hamedan
Postal code
6516845977
Phone
+98 81 1838 0150
Fax
Email
zahramid2001@yahoo.com; zahra.masoomi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)