Comparison of the effect of rosemary capsule and mefenamic acid on the quality of life of primary dysmenorrhea students
Design
Clinical trials with control group, parallel groups,Double blind,Sample size: 90 people,Phase trials:3
Settings and conduct
The study was double-blind in groups A and B at Mashhad Islamic Azad University School of Medicine
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iran and is unmarried; The age of research units at least 18 years; have regular menstrual cycle; Pain a few hours before or at the same time occur with menstrual bleeding; Menstrual pain can take 3 days or less; The mean pain score on the visual analogue pain 40 to 70 mm; The past six months have severe psychological stress.
Exclusion criteria:The use of oral contraceptives or other steroid hormones; history of allergic reaction to mefenamic acid is consumed and rosemary؛ consume supplements.
Intervention groups
Control group: treated with mefenamic acid 250 mg every 8 hours for 2 menstrual cycle in the first three days of the menstrual cycle
Intervention group: Rosemary If not treated with capsules for 2 menstrual cycle every 8 hours for the first three days of the menstrual cycle.
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160622028586N2
Registration date:2018-06-07, 1397/03/17
Registration timing:registered_while_recruiting
Last update:2018-06-07, 1397/03/17
Update count:0
Registration date
2018-06-07, 1397/03/17
Registrant information
Name
Fahimeh Tahoonian Golkhatmy
Name of organization / entity
School of Nursing and Midwifery, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3846 1567
Email address
tahounehf931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-10, 1397/02/20
Expected recruitment end date
2018-09-11, 1397/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of rosemary capsule and mefenamic acid on the quality of life of early painful menstruation students
Public title
Comparison of rosemary capsule and mefenamic acid on the quality of life of primary painful menstruation students
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Iran and is unmarried
The age of research units at least 18 years
Have regular menstrual cycle
Pain a few hours before or at the same time occur with menstrual bleeding
Menstrual pain can take 3 days or less
The mean pain score on the visual analogue pain 40 to 70 mm
The past six months have severe psychological stress
Is not known medical illness؛ Do not use a particular drug
Do not use a particular drug
Is not special diet such as weight loss diet, obesity, vegetarian and water treatment
Do not use Tobacco or alcohol؛ Do not regular exercise
Do not regular exercise; Do not have severe bleeding menstrual.
Exclusion criteria:
The use of oral contraceptives or other steroid hormones
History of allergic reaction to mefenamic acid is consumed and rosemary
Consume supplements
Age
From 18 years old to 25 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment by PASS software
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant, researcher, and evaluator of the outcomes dont know of the drug used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, University Ave
City
mashhad
Province
Razavi Khorasan
Postal code
91735951
Approval date
2018-05-09, 1397/02/19
Ethics committee reference number
IR.MUMS.REC.1397.036
Health conditions studied
1
Description of health condition studied
Quality of life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life
Timepoint
30 days
Method of measurement
Quality of Life Questionnaire (SF-36)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: treated with Mefenamic Acid 250 mg every 8 hours for 2 menstrual cycle in the first three days of the menstrual cycle
Category
Treatment - Drugs
2
Description
Intervention group: Rosemary If not treated with capsules for 2 menstrual cycle every 8 hours for the first three days of the menstrual cycle.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Islamic Azad University School of Medicine
Full name of responsible person
Fahimeh Tahoonian Gholkhatmy
Street address
No. Imam Khomeini 14, Bazarche Sarab
City
Mashhad
Province
Razavi Khorasan
Postal code
9133736351
Phone
+98 51 3228 0260
Fax
+98 51 3225 0048
Email
tahounehf931@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
University Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
917751365
Phone
+98 51 3882 3255
Fax
+98 51 3882 3251
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fahimeh Tahoonian Gholkhatmy
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Mashhad University of Medical Sciences, Ebnecina Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3225 0048
Email
tahounehf931@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Abedian
Position
Lecture, Department of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Mashhad University of Medical Sciences, Ebnecina Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
abedianz@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fahimeh Tahoonian Golkhatmi
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Mashhad University of Medical Sciences, Ebnecina Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
tahounehf931@mums.ac.ir
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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
data can shaied
When the data will become available and for how long
After publishing articles
To whom data/document is available
researchers
Under which criteria data/document could be used
People who want to investigate.
From where data/document is obtainable
Send the person responsible for the email.
What processes are involved for a request to access data/document