Introduction: vitamin E has beneficial effects on reduction of muscular pain.
This study evaluates the effect of vitamin E on decrease of muscular pain before of menstrual in students affected by premenstrual syndrome in 2013.
Methods: The present study was a double-blind, randomized clinical trial. 75 students in students that accommodate in Islamic Azad university of Touyserkan, Hamedan, Iran. They were randomly divided into two reception groups of vitamin E and placebo. Participants in reception group of vitamin E were use capsules 400unit daily in 7 days premenstrual for a 2 month period and students in placebo group used capsules similar vitamin E group . Data were gathered by questionnaires. The rate of pain in before and after of drug use was measured by Visual Analog Scale. They were applied before the commencement of intervention, on 1st month and 2rd month, respectively. Data analysis was carried out using Wilcoxon and Chi-square tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312188360N2
Registration date:2013-12-26, 1392/10/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-26, 1392/10/05
Registrant information
Name
Ensiyeh Jenabi
Name of organization / entity
Islamic Azad university
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 1439
Email address
e.jenabi@tuyiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University,Touyserkan Branch
Expected recruitment start date
2013-05-31, 1392/03/10
Expected recruitment end date
2013-09-01, 1392/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin E on decrease of muscular pain before of menstrual in students affected by premenstrual syndrome in 2013.
Public title
The effect of vitamin E on decrease of muscular pain before of menstrual in students affected by premenstrual syndrome in 2013.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: having premenstual syndrome; being single; agree to participate in study. Exclusion criteria: uterine disorders; UTI; irerigular menstruation; using of drug about PMS.
Age
From 18 years old to 24 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
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
Islamic Azad university,Touyserkan Branch
Street address
Islamic Azad university,Touyserkan Branch
City
Touyserkan
Postal code
Approval date
2013-05-08, 1392/02/18
Ethics committee reference number
23467/92
Health conditions studied
1
Description of health condition studied
Prementual syndrome
ICD-10 code
N94
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
muscular pain of before mens
Timepoint
3
Method of measurement
Visual Analog scale
Secondary outcomes
empty
Intervention groups
1
Description
subjects used placebo 7 days before of mens and 1 capsule in day for mens two cycles.
Category
Placebo
2
Description
subjects used capsule vitamin E (400 internationa unit) 7 days before of mens and 1 capsule in day for two mens cycles
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitory of Touyserkan Azad university
Full name of responsible person
Street address
City
Touyserkan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad university,Touyserkan Branch
Full name of responsible person
Dr. Vazini
Street address
Touyserkan Azad University
City
Touyserkan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad university,Touyserkan Branch
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
Islamic Azad university,Touyserkan Branch
Full name of responsible person
Parisa Hejrati
Position
MSc
Other areas of specialty/work
Street address
Azad University of Touyserkan
City
Touyserkan
Postal code
Phone
+98 85 2422 6635
Fax
Email
hejratiparisa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad university,Touyserkan Branch
Full name of responsible person
Ensiyeh Jenabi
Position
MSc
Other areas of specialty/work
Street address
Islamic Azad university,Touyserkan Branch
City
Touyserkan
Postal code
Phone
+98 85 2422 0253
Fax
Email
en.jenabi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad university,Touyserkan Branch
Full name of responsible person
Ensiyeh jenabi
Position
MSc
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
+98 81 1822 1439
Email
enciehjenabi@yahoo.ca
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)