Comparison the effectiveness of the use of glyceryl three nitrate ointment and mefenamic acid on pain, headache, and gastrointestinal disorders in primary dysmenorrhea women aged 18 to 30 years old without delivery
This is a single blind, single- center randomized clinical trial. The aim of this study is to compare the effect of glyceryl trinitrate ointment and mefenamic acid capsule on dysmenorrhea. Our sample size is 160 who are enrolled based on inclusion criteria.The patients are randomly divided into two groups.
The first group uses 2.5 mg glyceryl trinitrate ointment for 4 hours on the abdomen skin and under navel for 2 days. In the second group, 250 mg mefenamic acid capsule is administered every 8 hours per day for 48 hours. Treatment continues for three cycles of menses. Then patients are asked to express their pain with a number from 0 to 10. The amount of dysmenorrhea is analyzed between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121311020N9
Registration date:2017-01-10, 1395/10/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-10, 1395/10/21
Registrant information
Name
Maryam Khoshideh
Name of organization / entity
Tehran University of Medical Sciences, Arash Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 0909
Email address
khooshide@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Science
Expected recruitment start date
2013-05-05, 1392/02/15
Expected recruitment end date
2016-02-01, 1394/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effectiveness of the use of glyceryl three nitrate ointment and mefenamic acid on pain, headache, and gastrointestinal disorders in primary dysmenorrhea women aged 18 to 30 years old without delivery
Public title
Effects of glyceryl three nitrate ointment and mefenamic acid capsule on treatment of dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18 to 30 years old, primary dysmenorrhea; BMI between 19 and 27; normal ultrasonography, no history of birth
Exclusion criteria: Abnormal ultrasound, pelvic and cardiovascular disease, alcohol consumption, drug addiction
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences , Deputy of Research
Street address
Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2008-01-23, 1386/11/03
Ethics committee reference number
1133
Health conditions studied
1
Description of health condition studied
primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
dysmenorrhea
Timepoint
every 4 hours up to 48 hours after treatment
Method of measurement
VAS
Secondary outcomes
1
Description
headache
Timepoint
every 4 hours up 48 hours after treatment
Method of measurement
asking the patient
2
Description
gastrointestinal disorder
Timepoint
every 4 hours up 48 hours after treatment
Method of measurement
asking the patient
Intervention groups
1
Description
Intervention group: Patients use 2.5 mg glyceryl trinitrate ointment for 4 hours on the abdomen skin and under navel for 2 days in three cycles of their menses.
Category
Treatment - Drugs
2
Description
Control group: Patients use 250 mg mefenamic acid capsules every 8 hours per day for 48 hours in their three cycles of menses.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abitleb Hospital
Full name of responsible person
Dr. Maryam Khooshide
Street address
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Science
Full name of responsible person
Dr. Mohammad Hashemi
Street address
Khlije Fars boulevard
City
Zahedan
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, Zahedan University of Medical Science
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
Tehran University of Medical Science
Full name of responsible person
Dr. Maryam Khooshide
Position
gynecologist
Other areas of specialty/work
Street address
Arash women hospital, Rashid street, Resalat highway,Tehranpars