Objective: Comparison of pain and menstrual bleeding before and after intervention in clients that complains of primary dysmenorrhea with taking and Mefenamic acid capsules.Design: This study was a single-blind clinical trial conducting.Setting and conduct: Research units with Inclusion criteria easy sampling was after completing the list of questionnaire and obtaining informed consent of subjects enrolled in research and they will be asked the most severe pain at the end of each day (The first three days) and the amount of menstrual cycle (within 7 days of menstrual bleeding) specified in the list of first and second cycle and then delivered to researcher. Research units were randomly assigned to groups based on the Lottery allocated into bromelain and Mefenamic acid groups and had given bromelain and Mefenamic acid capsules that their nature is identified with the letters A and B delivered to research units and they will be asked to take the drugs in the first three days of the first and second cycles of intervention and complete the questionnaire and to submit researcher.The study population:90 students living in dorms of velayat university of iranshahr with primary dysmenorrhea who have Inclusion criteria: having regular menstrual cycles; age range between 18-25 years; having menstrual periods of moderate to severe primary dysmenorrhea grade based on Wong-Baker scale picture of pain.Exclusion criteria: Having a history of uterine problems; having hormone therapy at least three months before or during the course;Medical disease. Intervention: The first intervention group: treated with bromelain 250 mg for two menstrual cycles every 6 hours for the first three days of the menstrual cycle. The second intervention group: treated with mefenamic acid 250 mg every 6 hours for two menstrual cycles in the first three days of the menstrual cycle. Main outcome measures : Primary dysmenorrhea pain, menstrual bleeding.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112131000N1
Registration date:2016-12-26, 1395/10/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-26, 1395/10/06
Registrant information
Name
Bibi Maryam Mirlashari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 3007
Email address
mirlm931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-12-06, 1395/09/16
Expected recruitment end date
2017-04-05, 1396/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of bromelain and Mefenamic acid on primary dysmenorrhea pain and bleeding
Public title
Bromelan's effect on the pain and bleeding of Primary dysmenorrhea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Iranian and being single; age range between 18-25 years; education in fields except medical science; female students studying in Iranshahr velayat university dormitories; Having the characteristics of primary dysmenorrhea(Pain period with the start a few hours before or Simultaneous of menstrual bleeding and continued for up to 72 hours); having regular menstrual periods; having menstrual periods of moderate to severe primary dysmenorrhea grade based on Wong-Baker scale picture of pain. .Exclusion criteria:Having a history of uterine problems; Continually taking certain drugs; having hormone therapy at least three months before or during the course; A special diet, such as vegetarian diets and water; Psychological stress during the last six months; professional athlete; Having coagulation disorders; High blood pressure; Liver and kidney disorders;Medical disease.
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Mashhad University of Medical Sciences
Street address
University Avenue, Building Qureshi
City
Mashhad
Postal code
13944-91388
Approval date
2016-07-16, 1395/04/26
Ethics committee reference number
IR.MUMUS.REC.1395.230
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Pain and bleeding
Timepoint
Two cycles before the intervention
Method of measurement
the first and second cycles of the intervention
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group:treated with Bromelain 250 mg every 6 hours for 2 menstrual cycle in the first three days of the menstrual cycle
Category
Treatment - Drugs
2
Description
The second intervention group: treated with mefenamic acid 250 mg every 6 hours for 2 menstrual cycle in the first three days of the menstrual cycle
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat University of Iranshahr
Full name of responsible person
Bibi Maryam Mirlashari. Graduate Student Midwives
Street address
5 km highway martyr Moradi,Velayat University
City
Iranshahr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodiy
Street address
University Avenue. Central Organization of Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
00
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
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
Mashhad University of Medical Sciences
Full name of responsible person
Bibi Maryam Mirlashari
Position
Graduate Student Midwives
Other areas of specialty/work
Street address
Doctora intersection. Ibn Sina Street
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
mirlm931@mums.ac.ir, marylashari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Abedian
Position
Master of Midwifery
Other areas of specialty/work
Street address
Doctoora intersection. Ibn Sina Street
City
maashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
abedianz@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bibi Maryam Mirlashari
Position
Graduate Student Midwives
Other areas of specialty/work
Street address
Doctora intersection. Ibn Sina Street
City
mashad
Postal code
Phone
+98 51 3859 1511
Fax
Email
mirlm931@mums.ac.ir, marylashari@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)