The aim of this study is to determine the Effect of Menstrugloe capsule and Vitamin E on Primary Dysmenorrhea of students in Hamadan University of Medical Sciences, Hamadan, Iran in 2017. The present study is a clinical trial study with three-group design with two stages of befor and after intervention. The research Community consists of students in Hamadan University of Medical Sciences. The research sample consisted of students in Hamadan University of Medical Sciences who had inclusion criteria (ages 18-30 and having Primary Dysmenorrhea ) in the research environment (120 people) were enrolled in the study. Witten informed consent will obtain from all participants. The participants will be randomly allocated to one of three oral treatments groups: Menstrugloe capsule (500mg/day) or Vitamin E (200mg/day) or Placebo. Demographic Questionnaire and the Dysmenorrhea Multidimensional Speech Scale and McGill Pain ruler are used. Severity of Primary Dysmenorrhea will compare the three groups before and after treatment intervention end of two months. Data were analyzed using descriptive and inferential statistical methods.
General information
Acronym
Primary Dysmenorrhea
IRCT registration information
IRCT registration number:IRCT201707306888N18
Registration date:2017-09-02, 1396/06/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-02, 1396/06/11
Registrant information
Name
Fatemeh Shobeiri
Name of organization / entity
Hamadan Universiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
shobeiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences, Hamadan, Iran
Expected recruitment start date
2017-09-01, 1396/06/10
Expected recruitment end date
2017-12-01, 1396/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Menstrugloe Capsule and Vitamin E on Primary Dysmenorrhea
Public title
Comparison of the Effect of Menstrugloe Capsule and Vitamin E on Primary Dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Student; Age between 18-30 years; Having Primary Dysmenorrhea; Lack of allergy to drugs, Exclusion criteria: Allergy to drugs; Unwillingness to continue cooperation.
Age
From 18 years old to 30 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Department of Research and Technology, Fahmideh street, Hamadan
City
Hamadan
Postal code
6517838698
Approval date
2017-07-29, 1396/05/07
Ethics committee reference number
IR. UMSHA.REC.1396.341
Health conditions studied
1
Description of health condition studied
Dysmenorrhea
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain
Primary outcomes
1
Description
Severity of dysmenorrhea
Timepoint
Before the intervention and two month after the intervention
Method of measurement
Dysmenorrhea Multidimensional Speech Scale and McGill Pain ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Prescription oral Menstrugloe capsule (500mg/day), produced by Gol Daroo Company for 2 months.
Category
Treatment - Drugs
2
Description
Intervention group: Prescription oral Vitamin E (200mg/day), produced by Daana Pharmacy Company for 2 months.
Category
Treatment - Drugs
3
Description
Control group: Prescription oral Placebo (1 capsule /day), produced by Gol Daroo Company for 2 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Street address
Street Shahid Fahmideh, Hamedan University of Medical Sciences
City
Street Shahid Fahmideh, Hamedan University of Medical Sciences
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Research and Technology Deputy, Hamadan University of Medical Sciences, Shahid Fahmideh street, Hamadan
City
Hamadan
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 and Technology, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Position
PhD Maternal and Child Health / Professor
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Faculty of Nursing and Midwifery, Shahid Fahmideh street, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3822 0123
Fax
Email
fshobeiri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Position
PhD Maternal and Child Health / Professor
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Faculty of Nursing and Midwifery, Shahid Fahmideh street, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 0150
Fax
Email
fshobeiri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Position
PhD Maternal and Child Health / Professor
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Faculty of Nursing and Midwifery, Shahid Fahmideh street, Hamadan
City
Hamadan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)