Comparison of the efficacy of Rosa damascena extract and mefenamic acid on the severity of the primary dysmenorrhea pain: A double – blind randomized controlled trial
Objective: Comparison of the efficacy of Rosa damascena extract and mefenamic acid on the severity of the primary dysmenorrhea pain.
This study is designed as a randomized clinical, double-blind, single center and phase 3 trial.
Students of Tabriz University of Medical Science residing in kowsar dormitory fulfilling inclusion and exclusion criteria such as suffering from primary dysmenorrhea pain of 5-8 in vas system, absence of previous underlying genital disease, absence of previous abdomino-pelvic surgery will be enrolled in the study after signing the informed consent sheet.
92 students ( sample size) will be randomly allocated to two groups and will be treated for 3 consecutive days with either mefenamic acid or Rosa damascena extract for a single cycle; then for the next cycle the group using mefenamic acid will receive Rosa damascena extract and vice versa.
primary outcome is defined as the severity of dysmenorrhea pain and is measured using VAS system before and after interventions in predefined intervals . Primary outcome will be compared between two groups to assess the analgesic efficacy of mefenamic acid and Rosa damascena extract.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207267618N2
Registration date:2012-09-16, 1391/06/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-09-16, 1391/06/26
Registrant information
Name
Soheila Bani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
banis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Tabriz University of Medical Sience
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Rosa damascena extract and mefenamic acid on the severity of the primary dysmenorrhea pain: A double – blind randomized controlled trial
Public title
Comparison of the efficacy of Rosa damascena extract and mefenamic acid on the severity of the primary dysmenorrhea pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with abdominal pain compatible with dysmenorrhea; being single; signing the informed consent sheet.
Exclusion criteria: pain severity more than 8 or less than 5 according to visual analogue scale system; history of genitourinary disease or abdomino-pelvic surgery; stressful event(loss); lack of compliancy; history of hypersensitivity to mefenamic acid; using drugs that interact with mefenamic acid.
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:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research deputy of Tabriz University of Medical Sience
Street address
Central department of Tabriz University of Medical Sience, Golgasht street, Azadi street, Tabriz
City
Tabriz
Postal code
51665118
Approval date
2012-05-28, 1391/03/08
Ethics committee reference number
9159
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 dysmenorrhea pain
Timepoint
before the first intervention, after the first intervention, before the second intervention, after the second intervention
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:oral capsules containing 200 mg of Rosa damascena extract every 6 hours for the first 3 days of menstruation.
Category
Treatment - Drugs
2
Description
Control group: Oral capsules containing 250 mg of mefenamic acid every 6 hours for the first 3 days of menstruation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar dormitory of Tabriz University of Medical Sience
Full name of responsible person
Zeinab alsadat Moosavi
Street address
Kowsar dormitory of Tabriz University of Medical Sience, South Shariaty street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sience
Full name of responsible person
Dr Mohammadreza rashidi
Street address
Golgasht street, Azadi street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz University of Medical Sience
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
Tabriz University of Medical Sience
Full name of responsible person
Zeinab alsadat Moosavi
Position
MSC student of midwifery
Other areas of specialty/work
Street address
Faculty of nursing and midvifery, south shariaty street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
zeimous_hk@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of nursing and midvifery, Tabriz University of Medical Sience
Full name of responsible person
Soheila Bani
Position
MSC Midwifery
Other areas of specialty/work
Street address
Faculty of nursing and midvifery, South shariaty street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
banisoheila@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sience
Full name of responsible person
Zeinab alsadat Moosavi
Position
MSC student of midwifery
Other areas of specialty/work
Street address
Faculty of nursing and midvifery, South Shariaty street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
zeimous_hk@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)