Protocol summary

Summary
Design and methods: The study population will be women of 15-45, referred to the selected health centers, who will be affected by the PMS according to the criteria of American Psychiatry Association, and also met the inclusion criteria (being 15-45 years old; having regular menstrual cycle; not being affected by depression or anxiety: not having an acute or chronic disease; not taking medicine or supplements; and not taking regular exercise). The exclusion criteria will be pregnancy; willingness to use hormonal contraceptive methods or taking hormonal treatment; not taking the drug or not filling out the forms regularly; and unwillingness to continue the treatment. The patients will be randomly assigned to two intervention groups and one control group. The study will be carried out for four months in ten selected health centers in Isfahan. The primary health measure in this study is premenstrual syndrome severity that will be recognized by scoring on daily symptoms test. To confirm the PMS diagnosis in patients, they will be asked to fill out the PMS daily symptom record form for two months and then .when the diagnosis will be confirmed, the patients will be randomly assigned to one of the four groups of the study) magnesium, vitamin B6,B6- magnesium and placebo).Medical intervention in the shape of consuming one tablet in the day, will be carried out in two menstrual cycles and the result of pre- and post-test will be compared. The type of consuming material in this assay will be magnesium oxide (MgO) and pyridoxine powder that produced by MERK company and Drug faculty of Isfahan University will make these productions in the shapes of 250 milligram magnesium tablet, 40 milligram vitamin B6 tablet and 250 milligram magnesium +40 milligram vitamin B6 .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201106216854N1
Registration date: 2011-07-19, 1390/04/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-07-19, 1390/04/28
Registrant information
Name
Elham Ebrahimi
Name of organization / entity
Azad University
Country
Iran (Islamic Republic of)
Phone
+98 22 1522 3903
Email address
ebrahimi_308@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2010-04-14, 1389/01/25
Expected recruitment end date
2010-09-16, 1389/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of magnesium,vitamin b6 and b6-magnesium combination on premenstrual syndrome in the affected persons that going to medical health centers of isfahan university
Public title
determining the effect of magnesium,vitamin b6 and b6-magnesium combination on premenstrual syndrome in the affected persons that going to medical health centers of isfahan university
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterial: The study population will be women of 45-15 referred to the selected health centers; who were affected by the PMS according to the criteria of American Psychiatry Association; and also met the inclusion criteria; being 45-15 years old; having regular menstrual cycle; not being affected by depression or anxiety; not having an acute or chronic disease; not taking medicines or supplements; and not taking regular exercise) exclusion criterial: will be pregnancy; willingness to use hormonal contraceptive methods or taking hormonal treatment; not taking the drug or not filling out the forms regularly; and unwillingness to continue the treatment
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 170
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
Ethical Committee of Isfahan University of Medical Sciences
Street address
Isfahan university of medical science, Hezarjarib street, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2010-03-14, 1388/12/23
Ethics committee reference number
388554

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
premenstrual syndrome severity
Timepoint
2 month before and 2 month after intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
......
Timepoint
..........
Method of measurement
...........

Intervention groups

1

Description
Magnesium That consist of magnesium oxide (MgO) powder that produced by MERK company and Drug faculty of Isfahan University will make these productions in the shapes of 250 milligram magnesium tablet.the patients will use one tablet daily.
Category
Treatment - Drugs

2

Description
vitamin B6: Magnesium That consist of pyridoxine powder that produced by MERK company and Drug faculty of Isfahan University will make these productions in the shapes of 40 milligram vitamin B6 tablet.the patients will use one tablet daily.
Category
Treatment - Drugs

3

Description
placebo That consist of starch and Drug faculty of Isfahan University will make these productions in the shape of tablet.the patients will use one tablet daily.
Category
Placebo

4

Description
magnesium+vitamin b6 That consist of pyridoxine +magnesium oxide(MgO)powder that produced by MERK company and Drug faculty of Isfahan University will make these productions in the shapes of 40 milligram vitamin B6+250 milligram magnesium tablet.the patients will use one tablet daily.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan University of Medical Science health centers
Full name of responsible person
Nahid Fathizadeh
Street address
Isfahan University of Medical, Hezarjarib street, Isfahan, Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Isfahan University of Medical Sciences
Full name of responsible person
Mariam Kianpour
Street address
Nursing-Midwifery of Isfahan University of Medical Sciences, Hezarjarib street, Isfahan, Iran
City
Isfahan
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,Isfahan 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
Isfahan university of medical science
Full name of responsible person
Nahid Fathizadeh
Position
ms.
Other areas of specialty/work
Street address
Isfahan , university of medical science, Hezarjarib street,Isfahan , Iran
City
Isfahan
Postal code
Phone
+98 913 100 4312
Fax
Email
Fathizadeh@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Nahid Fathizade
Position
ms
Other areas of specialty/work
Street address
Isfahan university of medical science, Hezarjarib street, Isfahan , Iran
City
Isfahan
Postal code
Phone
+98 913 100 4312
Fax
Email
Fathizadeh@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Azad University
Full name of responsible person
Elham Ebrahimi
Position
Ms
Other areas of specialty/work
Street address
Azad university, Maraghe, Azarbaijan Sharghi
City
Postal code
Phone
Fax
Email
Ebrahimi_308@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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