The study, of experimental study (double blind clinical trial) is to evaluate the effect of Fennel and Gelofen Capsule on Primary Dysmenorrhea on students residing in dormitories Islamic Azad University of Ardabil Branch in 1394 that among the 770 students living in dormitories 105 students with Dysmenorrhea volunteer for the study and are satisfied that the sampling will be selected from volunteers participating in the study, and of these, 72 patients with Primary Dysmenorrhea grade 2 and 3 that meet the specifications in the study are selected, then they will randomly divided into two groups: experience group (recipient of Fennel) and control group (receiving Gelofen)Data collection tools include questionnaire that will be 5 parts. Experimental group and control group, in the first 3 days per cycle periods, respectively will receive, Fennel Oil 3-5 drop into water or tea 3 times a day and Gelofen 400 milligram 4 Capsules per day (one capsule every 6 hours) for three consecutive cycles and will be followed-up and then after collecting the questionnaires, the data will be analyzed doing. The research hypothesis is as follows: There is no difference between the severity of the pain and associated symptoms during menstruation in students receiving Fennel and Gelofen.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060728313N1
Registration date:2016-08-12, 1395/05/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-12, 1395/05/22
Registrant information
Name
Roya Motavalli
Name of organization / entity
Islamic Azad University Of Ardabil Branch
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 8024
Email address
m.motavalli@iauardabil.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University Of Ardabil Branch
Expected recruitment start date
2016-06-09, 1395/03/20
Expected recruitment end date
2016-09-10, 1395/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Fennel and Gelofen on the severity of primary Menstrual pain
Public title
The effect of Fennel on treatment Dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The incidence of primary dysmenorrhea grade 2 and 3 according to verbal multidimensional scoring criteria.
Exclusion criteria: Use of birth control pills and herbal medicines; As well as painkillers and other relaxation techniques or acupressure to relieve dysmenorrhea; Having of renal; hepatic; respiratory; and blood diseases; Having of sensitivity to NSAIDs and fennel.
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:
72
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
Islamic Azad University Of Ardabil Branch
Street address
Basij Square, Ardabil, Iran
City
Ardabil
Postal code
5615731567
Approval date
2016-04-09, 1395/01/21
Ethics committee reference number
IR.IAU.ARDABIL.REC.1395.1
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
The severity of Menstrual pain
Timepoint
Three months after the begining of interaction
Method of measurement
Verbal Multidimensional Scoring Criteria
Secondary outcomes
1
Description
Side Effects
Timepoint
Three months after the begining of interaction
Method of measurement
Questionnaire
Intervention groups
1
Description
Medicine and registration form (for before and after the use of medicine) for the first cycle will be distributed and information on how to take the medicine is presented to everybody in Experimental Group. The Experimental Group will use Fennel Drop in three first day of Menstrual cycle, 3-5 drops in tea or water 3 times a day (every 8 hours) in 3 continuous series of Menstrual cycles. At the end of each cycle by fellow researchers collected clinical status and drug registration forms and will distributed new forms and medicine. The samples will be followed-up after three consecutive cycles. Verbal Multidimensional Scoring System to determine the severity of Menstrual pain is used to determine the presence or absence of symptoms associated with pain will be determined as well as through a Questionnaire.
Category
Treatment - Other
2
Description
Medicine and registration form (for before and after the use of medicine) for the first cycle will be distributed and information on how to take the medicine is presented to everybody in Control Group. The Control Group also use Gelofen Capsules at a dose of 400 milligram 4 times per day with meals or a glass of water in the first 3 days of the Menstrual cycle. At the end of each cycle by fellow researchers collected clinical status and drug registration forms and will distributed new forms and medicine. The samples will be followed-up after three consecutive cycles. Verbal Multidimensional Scoring System to determine the severity of Menstrual pain is used to determine the presence or absence of symptoms associated with pain will be determined as well as through a Questionnaire.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Student Dormitory Of Islamic Azad University Ardabil Branch
Full name of responsible person
Roya motavalli (Master of Midwifery, Faculty)
Street address
Hafez Street, Ardabil, Iran
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University Of Ardabil Branch
Full name of responsible person
Dr Mohamad Zaefizadeh (Research Assistant)
Street address
Basij square, Ardabil, Iran
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Of Ardabil Branch
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
Islamic Azad University Of Ardabil Branch
Full name of responsible person
Roya Motavalli
Position
Master of Midwifery, Faculty
Other areas of specialty/work
Street address
Basij Square, Ardabil, Iran
City
Ardabil
Postal code
5615731567
Phone
+98 45 3372 8025
Fax
+98 45 3371 5514
Email
mrmotavalli@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Of Ardabil Branch
Full name of responsible person
Dr Parvin Nakhostinroohy
Position
Obstetricians, Assistant Professor
Other areas of specialty/work
Street address
Basij Square, Arbabil, Iran
City
Ardabil
Postal code
5615731567
Phone
+98 45 3372 8025
Fax
+98 45 3371 5514
Email
mrmotavalli@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Of Ardabil Branch
Full name of responsible person
Roya Motavalli
Position
Master Of Midwifery, Faculty
Other areas of specialty/work
Street address
Basij Square, Ardabil, Iran
City
Ardabil
Postal code
5615731567
Phone
+98 45 3372 8025
Fax
+98 45 3371 5514
Email
mrmotavalli@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)