Dysmenorrhea is the most common gynecological problem and is associated with outcomes such as getting absent from work and school and high health cost. The aim of this study was to compare the effect of Mefenamic acid and Ginger capsules and exercise on primary dysmenorrhea. female students of Mazandaran University of Medical Sciences with primary dysmenorrhea would be selected by random allocation to three intervention groups. Inclusion criteria include: moderate to severe primary dysmenorrhea for at least one day per cycle and exclusion criteria are secondary dysmenorrhea , OCP, IUD, irregular cycle and regular exercise. The initial pain in each group is measured by Visual Analogue Scale. The first group would be received 250mg Mefenamic acid every eight hours and Ginger group 250mg capsule every 6 hours and exercise group a 5 minute exercise exercise, 6 stretching exercise 3 times weekly, for 15 minutes. Pain is measured in groups for 2 cycles.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203118822N2
Registration date:2013-12-04, 1392/09/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-04, 1392/09/13
Registrant information
Name
Narges Motahari
Name of organization / entity
Mazandaran University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 7345
Email address
n.motahari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University Of Medical Sciences
Expected recruitment start date
2013-10-22, 1392/07/30
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effectiveness Of Mefenamic acid Capsules, Ginger and Stretching Exercise On Primary Dysmenorrhea
Public title
Comparison Of Mefenamic acid Capsules and Ginger and Exercise On Pain During Mensturation
Purpose
Health service research
Inclusion/Exclusion criteria
individuals who have primary dysmenorrhea, the pain that affects their daily activities participated in study.Inclusion criteria:The pain is moderate to severe; pain during the menstrual cycle and in more than 50% for at least one day exist. Exclusion criteria: having a menstrual cycle irregular (usually outside the range of 21 to 35 days); use of IUD or receiving OCP; history of exercise regularly (3 times a week for 30 to 45 minutes) and having dysmenorrhea secondary.
Age
From 18 years old to 30 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
61
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University Of Medical Sciences
Street address
Mazandaran University Of Medical Sciences, Three Ways Juybar, Imam Sqare
City
Sari
Postal code
4816715793
Approval date
2013-09-11, 1392/06/20
Ethics committee reference number
1392/6/20
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
Reduce the severity of dysmenorrhea
Timepoint
Before intervention then twice every month
Method of measurement
VAS scale
Secondary outcomes
1
Description
Drug side effects
Timepoint
Before starting intervention and then at intervals of twice a month
Method of measurement
VAS scale
2
Description
Reduce the amount of bleeding
Timepoint
Before starting intervention and then at intervals of twice a month
Method of measurement
VAS scale
3
Description
Duration of pain
Timepoint
Before starting intervention and then at intervals of twice a month
Method of measurement
VAS scale
Intervention groups
1
Description
Exercise group: 5 Minutes of movement exercise for the whole body in a standing position in order to warm up the body and then 6 stretch exercise in the abdomen and pelvis is performed for 10 minutes. These exercises 3 times weekly for 15 minutes for 2 cycles (8 weeks ) are performed . Exercises are not in menstruating. these exercises will be taught by two trained instructors and supervised by the investigator to be done.
Category
Treatment - Drugs
2
Description
In Ginger group: 250 mg capsules (Goldarue Company) is taken every 6 hours until pain relief for 2 cycles
Category
Treatment - Drugs
3
Description
In Mefenamic group: 250 mg capsules (Razak Company) is taken every 8 hours until pain relief for 2 cycles
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran University Of Medical Sciences
Full name of responsible person
Narges Sadat Motahari
Street address
Mazandaran University Of Medical Sciences, Three Ways Juybar, Imam Sqare
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Dr Enayati
Street address
Mazandaran University Of Medical Sciences, Three Ways Juybar, Imam Sqare
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University Of Medical Sciences
Full name of responsible person
Narges Sadat Motahari
Position
BS Of Midwifery and MSc Of Sport Science - Instructor Of Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery School, Vesal Street, Amirmazandarani Blvd, Sari, Mazandaran
City
Sari
Postal code
4816715793
Phone
+98 15 1226 7342
Fax
Email
n.motahari@mazums.ac.ir narges_mth@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran Univerciy Of Medical Sciences
Full name of responsible person
Narges Sadat Motahari
Position
Msc Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery School, Vesal Street, Amirmazandarani Blvd, Sari, Mazandaran
City
Sari
Postal code
4816715793
Phone
+98 15 1226 7342
Fax
Email
shirvani44@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Narges Sadat Motahari
Position
BSc Of Midwifery and MSc Sport Science - Instructor Of Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery School, Vesal Street, Amirmazandarani Blvd, Sari, Mazandaran
City
Sari
Postal code
4816715793
Phone
+98 15 1226 7342
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)