The purpose of this study was to compare the effects of vitamin D, vitamin E, ginger and placebo on the severity of primary dysmenorrhea.
Design
This randomized, double-blind, single- centered clinical trial is a control group. Participants 200 single students aged between 30 and 18 years old living in Qazvin's medical residences who have moderate and severe primary dysmenorrhea.
Settings and conduct
In all groups, medications are taken two days before and three days after menstruation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Single girls aged 18-30 years with regular period of 35-21 days and exclusion criteria: underlying disease; use of contraceptive pills.
Intervention groups
Participants are divided into 4 groups: one group of vitamins E 200 units per day, the second group vitamin D 1000 units once a day, the third group of ginger tablets 500 mg twice a day and the fourth group of placebo tablets twice a day they receive.
Main outcome variables
The severity of pain is measured on the effects of menstrual periods with visual analogue tools before and after the first and second cycles of intervention after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120104008611N7
Registration date:2018-03-09, 1396/12/18
Registration timing:retrospective
Last update:2018-03-09, 1396/12/18
Update count:0
Registration date
2018-03-09, 1396/12/18
Registrant information
Name
Hamideh Pakniat
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 282242452
Email address
hpakniat@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2017-12-22, 1396/10/01
Trial completion date
empty
Scientific title
Comparison of the effect of vitamin D, vitamin E and ginger on the severity of primary dysmenorrhea among students
Public title
Comparison of the effect of vitamin D, vitamin E and ginger on pain intensity of menstruation among students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18- 30 year old single girls with a regular menstruation cycles of 21- 35 days
The regular period is 35-21 days
Duration of 3-7 days
Moderate or severe dysmenorrhea
Exclusion criteria:
Underlying disease; and medications
Any analgesic
Using contraceptive pills
Drug and herbal susceptibility
Age
From 18 years old to 30 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
200
Actual sample size reached:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly assigned into four groups of intervention and control. Medications are individually encoded in sealed envelopes and delivered to the participants. The participants and the individual who supplies the medication do not know the type of medication in the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications are individually encoded in sealed envelopes and delivered to the participants. The participants and the individual who supplies the medication do not know the type of medication in the envelope But with complete notification and satisfaction, it is included in the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Approval date
2016-11-26, 1395/09/06
Ethics committee reference number
IR.QUMS.REC.1395.205
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Severity of pain
Timepoint
Monthly
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vitamin E 200 units per day
Category
Treatment - Drugs
2
Description
Intervention group: Vitamin D 1000 units once a day
Category
Treatment - Drugs
3
Description
Intervention group: Ginger Pills 500 mg twice a day
Category
Treatment - Drugs
4
Description
Control group: Placebo tablets 2 times a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Female Dormitories of Ghazvin University of Medical Sciences
Full name of responsible person
Dr Hamideh Pakniat
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 21 3223 6374
Email
pakniat110@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peymani
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3223 6374
Email
pakniat110@yahoo.com
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 of Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kowsar Hospital
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3223 6374
Fax
Email
pakniat110@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3223 6374
Fax
Email
pakniat110@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kowsar Hospital
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3223 6374
Fax
Email
hpakniat@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information is the most commonly used questionnaire, which is a statistical analysis
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
Path analysis
From where data/document is obtainable
Dr Hamideh Pakniat executor of plan
What processes are involved for a request to access data/document
The email will be submitted to the project promoter at the discretion of the information.