This study assesses the impact of vitamin B1 on the intensity of primary dysmenorrhea. Inclusion criteria were included: having primary dysmenorrhea؛ single؛Consent for participates in this study and
Exclusion criteria were infected to uterine disease and urinary system؛ irregular mens and drug using ralated to dysmenorrhea .
This randomized clinical trial is conducted on 124 female students' of Islamic Azad University of Hamedan, Iran, who met the inclusion criteria. The participants are randomly assigned to two groups. The treatment is started by administrating for loteal phase vitamin B1 100mg/day for the experimental group (62 paticipate in vitamin B1 group) and placebo 1/day for the control group (62 participate in placebo group). Finally, the two groups are compared in terms of the dysmenorrhea severity pain by Visual Analog Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014071318458N1
Registration date:2014-08-29, 1393/06/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-29, 1393/06/07
Registrant information
Name
Mahnaz Azadi Moghtader
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 818221439
Email address
ma.moghtader@tuyiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad university, Hamadan Branch
Expected recruitment start date
2013-07-15, 1392/04/24
Expected recruitment end date
2014-01-14, 1392/10/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of vitamin B1 and placebo effects on the relief of primary dysmenorrheal in university student of Islamic Azad University.
Public title
The comparison of vitamin B1 and placebo effects on the relief of primary dysmenorrheal in university student of Islamic Azad University.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion ceriteria: single women, primary dysmenorrhea؛ ؛Consent for participating in this study
Exclusion criteria:any uterine disease or urinary system؛ irregular mensturation؛ drug using ralated to dysmenorrhea
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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, Hamedan Branch
Street address
Islamic Azad University, Hamedan, Iran
City
Hamadan
Postal code
Iran
Approval date
2013-04-21, 1392/02/01
Ethics committee reference number
1367/92
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
ِDysmenorrhea
Timepoint
Study begining, First Mounth, Second Mouunth
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Vitamin B1, dose 100 milligram, daily/for 15 day in loteal phase in 2 months
Category
Treatment - Drugs
2
Description
Placebo, dose 100 miligram, daily for 15 day in loteal phase in 2 mouth
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad university of Hamadan
Full name of responsible person
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Hamadan
Full name of responsible person
Dr.Esfandyari Moghadam
Street address
Islamic Azad University of Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Hamadan
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
Azad University of tuyserkan
Full name of responsible person
Ensiyeh Jenabi
Position
MsC
Other areas of specialty/work
Street address
Azad university of tuyserkan
City
tuyserkan
Postal code
Iran
Phone
+98 814220253
Fax
Email
enciehjenabi@yahoo.ca
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Azad university of Touyserkan
Full name of responsible person
Ensiyeh jenabi
Position
MsC
Other areas of specialty/work
Street address
Azad university of Tuyserkan
City
Tuyserkan
Postal code
0098814220253
Phone
+98 814220253
Fax
Email
enciehjenabi@yahoo.ca
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Mahnaz Azadimoghtader
Position
MSc in Nursing/Faculity
Other areas of specialty/work
Street address
Islamic Azad University,Hamedan Branch
City
Hamedan
Postal code
Phone
+98 818222779
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)