Primary dysmenorrhea refers to the occurrence of painful menstrual cramps of uterine origin by a hypersecretion of endometrial prostaglandins and is a gynecological complaint. Common treatment for this problem is medical therapy such as mefenamic acid (NSAIDs drugs) or oral contraceptive pills, which both work by reducing myometrial activity. One of useful herbal agents to reducing potential dysmenorrhea is fennel. This randomized clinical trial (RCT) single central study was compared fennel drop with mefenamic acid for reducing pain of primary dysmenorrhea. Inclusion criteria: student; live in dormitory; not smoker; without any systemic disease. Exclusion criteria: intolerance to fennel drop .sixty College students with moderate dysmenorrhea were randomly selected and flowed up two cycles. Informed consent were completed by all participants.29 Of 30 students, continue the study in study group and 30 students reminded in control group. In first month no extra medications used, but in second month in study group was taken fennel drop (Fennelin Oral Drop,Each ml contatian 15.5 mg Antole,Barijessence.com,25 drop every 6 hour) and they can use mefenamic acid( cap mefenamic acid 250mg ,Darou Pakhsh pharmaceutical Mfg.Co.Tehran - Iran)if necessary. Intensity of pain was determined by visual analogue scale (VAS) . These cycles were assessed day by day. Bleeding in each cycle compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107096826N2
Registration date:2011-07-28, 1390/05/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-28, 1390/05/06
Registrant information
Name
Mahshid Bokaie
Name of organization / entity
Shahid Sadougi university of medical sciences,Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1751
Email address
mah_bokaie@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences,Yazd, Iran
Expected recruitment start date
2010-08-17, 1389/05/26
Expected recruitment end date
2011-02-22, 1389/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of oral fennel drop in treatment of primary dysmenorrhea
Public title
Herbal drug and dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:student;live in dormitory;not smoker;without any systemic disease
Exclusion criteria:intolerance to fennel drop
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical sciences,Yazd, Iran
Street address
Bahonar sq-Shahid Sadoughi University of Medical sciences,Yazd, Iran
City
Yazd
Postal code
Approval date
2010-07-20, 1389/04/29
Ethics committee reference number
115799
Health conditions studied
1
Description of health condition studied
Dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Pain reducing
Timepoint
Before mensturation,first day up fifth day of mensturation
Method of measurement
Visual analogos scale
Secondary outcomes
1
Description
Mesturation pattern
Timepoint
First day up fifth day of mensturation
Method of measurement
Pad count
Intervention groups
1
Description
cap mefenamic acid 250mg (Darou Pakhsh pharmaceutical Mfg.Co.Tehran - Iran)
every 6 hour one cap PRN
Category
Treatment - Drugs
2
Description
Fennelin (Foeniculum vulgare) Oral Drop2%,Each ml contatian 15.5 mg Antole(Barijessence.com)
active ingredient: Trans Antole, Phenshon, Methyl Chavcol, Estragon
25 drop every 6 hour every day until she needed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roghaye female stunent dormitory of Shahid Sadoughi University
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical sciences,Yazd
Full name of responsible person
Fatemeh Ezodini Ardekani
Street address
Bahonar sq, Shahid Sadoughi University of Medical sciences,Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical sciences,Yazd
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
Shahid Sadougi University of Medical Sciences
Full name of responsible person
Mahshid Bokie
Position
MS
Other areas of specialty/work
Street address
Nursing and Midwifery collage
City
Yazd
Postal code
Phone
+98 35 1824 1751
Fax
Email
mahshidbokaie@gmail.com; mah_bokaie@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences,Yazd, Iran
Full name of responsible person
Mahshid Bokaie
Position
MS
Other areas of specialty/work
Street address
Nursing & Midwiferry Collage
City
Yazd
Postal code
Phone
+98 35 1528 1751
Fax
Email
mahshidbokaie@gmail.com; mah_bokaie@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mahshid Bokaie
Position
MS
Other areas of specialty/work
Street address
Nursing and midwifery collage
City
Yazd
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)