1. Objective: Comparison of mean pain intensity and amount of menstrual bleeding before and after intervention in clients that complains of primary dysmenorrheal with taking Rosemary and Mefenamic acid capsules.
2. Design: This study was a double-blind clinical trial conducting.
3. Setting and conduct: Research units with Inclusion criteria easy sampling was after completing the list ofquestionnaire and obtaining informed consent of subjects enrolled in research and they will be asked the most severe pain at the end of each day (3 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 software PASS Rosemary allocated into Rosemary and Mefenamic acid groups and had given Rosemary and Mefenamic acid capsules that their nature is identified with the letters A and B will be marked only for pharmacist consultant to be delivered to research units. They use in first three days first and second cycle intervention and complete the questionnaire and to submit researcher.
4. Participants including major eligibility criteria: students of Islamic Azad University Mashhad University of Medical Sciences with primary dysmenorrhea who have:
Inclusion criteria: regular menstrual cycles; A few hours before or concurrent pain with the of menstrual bleeding; have3 days or less menstrual pain; The mean pain score on the visual analogue pain is 40 to 70 mm; Don’t have known medical disease; Not to use a particular drug; Don’t have severe bleeding.
Exclusion criteria: the use of oral contraceptives or other steroid hormones; A history of allergic reaction to the use of rosemary and Mefenamic acid is present.
5. Intervention: Control group: treated with mefenamic acid 250 mg every 8 hours for two menstrual cycles in the first three days of the menstrual cycle.
Intervention group: treatment with rosemary capsules (containing 1 g) of alcoholic extract of rosemary two menstrual cycles every 8 hours for the first three days of the menstrual cycle.
6. Main outcome measures (variables): Primary dysmenorrhea pain, the amount of menstrual bleeding.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062228586N1
Registration date:2016-09-28, 1395/07/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-28, 1395/07/07
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
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of rosemary and Mefenamic Acid Capsules of amount of menstrual bleeding and Primary dysmenorrhea
Public title
Rosemary effect on the amount of menstrual bleeding and Primary dysmenorrhea
Purpose
Treatment
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؛ 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 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
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Ethics Committee
Street address
Mashhad University of Medical Sciences, University Ave
City
Mashhad
Postal code
Approval date
2016-06-23, 1395/04/03
Ethics committee reference number
IR.MUMS.REC.1395.162
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
Primary dysmenorrhea pain severity
Timepoint
3 the first day of menstrual bleeding
Method of measurement
According to the Visual Analogue Scale (vas)
Secondary outcomes
1
Description
The amount of menstrual bleeding
Timepoint
Menstrual bleeding period (7 days to 10 days menstrual cycle)
Method of measurement
Hygam chart
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
Bazarche Sarab, No. Imam Khomeini 14
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
University Ave
City
Mashhad
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,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
School of Nursing and Midwifery, Mashhad University of Medical Sciences
Full name of responsible person
Fahimeh Tahoonian Gholkhatmy
Position
Master of Midwifery student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashhad University of Medical Sciences, Ebnecina Avenue
City
Mashhad
Postal code
Phone
+98 51 3225 0041
Fax
Email
tahounehf931@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Mashhad University of Medical Sciences
Full name of responsible person
Zahra Abedian
Position
Lecture, Department of Midwifery, Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashhad University of Medical Sciences, Ebnecina Avenue
City
Mashhad
Postal code
Phone
+98 385981511
Fax
Email
abedianz@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Mashhad University of Medical Sciences
Full name of responsible person
Fahimeh Tahoonian Ghol khatmy
Position
Master of Midwifery student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashhad University of Medical Sciences, Ebnecina Avenue
City
Mashhad
Postal code
Phone
+98 51 3225 0041
Fax
Email
tahounehf931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)