The purpose of this controlled random clinical study is to determine the effect of vitamin B1 on the side effects caused by menstoration. This double-blinded clinical trial is performed on 98 unmarried student aged 18 to 26 who that they suffered from level 2 and 3 dysmenorrhea and menstruation cycle duration more than7 days and the number of sanitary napkins used more than 14 had no systemic or reproductive diseases, and who did not use contraceptive drugs between 1395 and 1396. Subjects were randomized into Two groups: Experimental group who received 100 mg vitamin B1pill, its placebo to the control group received. Each participant was monitored during 5 menstrual periods. During the first period participants documented their own Severity of dysmenorrheal and menstruation cycle duration without any intervention applied. During the second, third and forth period, one of the two applications (placebo or vitamin B1pill) was applied . .The samples are evaluated considering the pain and bleeding intensity finally one month later, after finishing intervention (without using drug & placebo).In this study, pain intensity is measured by Multidimensional questionnaires grading scales and menstrual bleeding by Higham chart.
General information
Acronym
Vitamin B1 on the menstruation’s complications
IRCT registration information
IRCT registration number:IRCT2017070710451N2
Registration date:2017-07-14, 1396/04/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-14, 1396/04/23
Registrant information
Name
Azam Jafari
Name of organization / entity
Islamic Azad University,Borujerd Branch
Country
Iran (Islamic Republic of)
Phone
+98 66 2351 8000
Email address
a.jafari@iaub.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University, Boroujerd Branch
Expected recruitment start date
2016-10-08, 1395/07/17
Expected recruitment end date
2017-10-09, 1396/07/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Vitamin B1 on the menstruation’s complications Living in a dormitory students
Public title
The Effect of Vitamin B1 on the menstruation’s complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: unmarried; age18-26; being literate; having regular menstruation period between 26-30 days; Pain a few hours before or at the same time occur with menstrual bleeding; Menstrual pain can take 3 days or less; menstruations bleeding duration more than7 days;the number of used sanitary napkins more than 14 numbers; Is not known medical illness; Is not special diet such as weight loss diet, obesity, vegetarian and water treatment; Do not use Tobacco or alcohol; Do not regular exercise.Exclusion criteria: The use of oral contraceptives or other steroid hormones; Existing of any kind of genital system diseases ;Background for kidney stone or any problems; any kind of diagnosed physical and psychological diseases.
Age
From 18 years old to 26 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
98
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,Arak Branch
Street address
University campus Amir Kabir , Imam Boulevard , Imam Squ,Islamic Azad University,Arak Branch
City
Arak
Postal code
38361-1-9131
Approval date
2016-10-08, 1395/07/17
Ethics committee reference number
IR.IAU.ARAK.REC.1395.2
Health conditions studied
1
Description of health condition studied
Pain and other conditions associated with female genital organs and menstrual cycle Excessive, frequent and irregular menstruation
ICD-10 code
N94.4-N92.
ICD-10 code description
N94.4 Primary dysmenorrhoeaN92.0 Excessive and frequent menstruation with regular cycle
Primary outcomes
1
Description
menstrual blood loss
Timepoint
Within 5 months with intervals of 1 month before intervention(at first) , and within 3 months after intervention and 1 month after finishing the intervention.
Method of measurement
Higham chart
2
Description
pain intensity
Timepoint
Within 5 months with intervals of 1 month before intervention(at first) , and within 3 months after intervention and 1 month after finishing the intervention.
Method of measurement
Multidimensional questionnaires grading scales
3
Description
pain duration
Timepoint
Within 5 months with intervals of 1 month before intervention(at first) , and within 3 months after intervention and 1 month after finishing the intervention.
Method of measurement
based on hours
Secondary outcomes
1
Description
spotting
Timepoint
Within 5 months with intervals of 1 month before intervention(at first) , and within 3 months after intervention and 1 month after finishing the intervention.
Method of measurement
Higham chart
Intervention groups
1
Description
100mg edible vitamin B1 pill per day for 3 months
Category
Treatment - Drugs
2
Description
In control group, edible placebo per day for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Student Dormitory
Full name of responsible person
Jafari Azam
Street address
Imam Khomeini university complex, yadegare Imam Ave, Navab Squ, Boroujerd
City
Boroujerd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University,Borujerd Branch
Full name of responsible person
Dr Mohammad Reza Moazami Goodarzi
Street address
Imam Khomeini university complex, yadegare Imam Ave, Navvab Squ, Boroujerd
City
Boroujerd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University,Borujerd 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,Borujerd Branch
Full name of responsible person
ziba latifiyan
Position
Master of Midwifery,university factulty
Other areas of specialty/work
Street address
Paramedic College, Modares Sq.
City
Boroujerd
Postal code
Phone
+98 66 4251 3042
Fax
Email
zb.latifiyan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University,Borujerd Branch
Full name of responsible person
Jafari Azam
Position
Master of Midwifery,university factulty
Other areas of specialty/work
Street address
Paramedic College, Modares Sq.
City
Boroujerd
Postal code
Phone
+98 66 4251 3042
Fax
Email
a.jafari@iaub.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University,Borujerd Branch
Full name of responsible person
Jafari Azam
Position
Master of Midwifery,university factulty
Other areas of specialty/work
Street address
Paramedic College, Modares Sq.
City
Boroujerd
Postal code
Phone
+98 66 4251 3042
Fax
Email
a.jafari@iaub.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)