Aim: The purpose of this study was Determine and Comparison the effects of combination extract Fennel and Vitamin E with Ibuprofen on the intensity in primary dysmenorrhoea in the Tabriz city students, 2007-2009. Mateial&Methods: This study was done by double-blinded Quasi Experimental Research method. 68 students from Medical and Tabriz Universities who were living in the dormitory, and suffering from primary dysmenorrhea and had condition of study were separated randomly in two groups ( N= 34). Inclusion criteria: primary dysmenorrhea with a sum score of Visual Analogue Scale 3.1- 9, Students with cyclic menstrual bleeding that cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to first visit... Exclusion criteria: Known or suspected NSAIDs allergy or suspected contraindication to herbal remedies... Then the samples recorded Intensity pain of primary dysmenorrhea without medication in the first month; and these groups used "combining extract Fennel and Vitamin E" and Ibuprofen cross-over form in the two mouths. we used VAS tool for defineing the intensity of the pain. Data analyzing was done by using Spss 14 win .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101225664N1
Registration date:2011-08-26, 1390/06/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-26, 1390/06/04
Registrant information
Name
Masoomeh Nasehi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1336 9482
Email address
nasehi_m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tabriz University of Medical Sciences
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2008-12-21, 1387/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of Fennel/Vitamin E and Ibuprofen on intensity of primary dysmenorrhea at students of Tabriz, 2007-2009.
Public title
Comparison effect of Fennel/Vitamin E and Ibuprofen on intensity of Primary dysmenorrhea at students of Tabriz, 2007-2009.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy single female students suffering from primary dysmenorrhea with a sum score of Visual Analogue Scale 3.1 – 9 " students who gained higher than 9.1 (severe dysmenorrhea) and lower than 3 (mild dysmenorrhea) were excluded from survey"; Students with cyclic menstrual bleeding that cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to first visit; Reviewing and Signing of informed consent; The onset of primary dysmenorrhea was before 20 years.
Exclusion criteria:
Severe pain in all of menstruation period or before onset of cycling bleeding; Known or suspected NSAIDs allergy or suspected contraindication to herbal remedies; Using of Oral Hormonal Contraception during treatment; History of pelvic major surgery; Presence or a history of seizure; severe gastrointestinal disorders or any diseases that might interfere with the conduct of the study or the interpretation of the results; Urinary tract infection in study period; Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator; Using of tranquilizer or any non medical treatment for dysmenorrhea pain relief.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
68
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
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical, Golgasht street, Tabriz, Iran.
City
Tabriz
Postal code
5165665931
Approval date
2008-10-26, 1387/08/05
Ethics committee reference number
8731
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhoea
ICD-10 code
N94.4 Pr
ICD-10 code description
N94 Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
Intensity of the pain of Primary dysmenorrhoea
Timepoint
Hours 1,2,3,6,12,24,48 after onset of bleeding
Method of measurement
Subjects recorded intensity of menstrual pain by Visual Analogue Scale(0-10)
Secondary outcomes
1
Description
---
Timepoint
-----------
Method of measurement
-----------
Intervention groups
1
Description
Cap 500 mg ( 60 mg Fennel extract / 150 UI Vitamin E ) QID N=1
at first two day of menstration
Category
Treatment - Drugs
2
Description
Cap Ibuprofen 400 mg
QID N=1
at first two day of menstration
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar dormitory
Full name of responsible person
Masoomeh Nasehi
Street address
Kosar dormitory, Finally South Shariati street, Tabriz, East Azarbayejan, Iran.
City
Tabriz
2
Recruitment center
Name of recruitment center
Fajr dormitory
Full name of responsible person
Masoomeh Nasehi
Street address
Fajr dormitory, Rah Ahan Street next to the Seventh Tir hospital, Tabriz, East Azarbayejan, Iran.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Reza Ostadrahimi
Street address
Tabriz University of Medical Sciences Research, Golgagsht Street, Tabriz, East Azarbayejan, Iran.
City
Tabriz
Grant name
10506
Grant code / Reference number
124202
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Urmia University of Medical Sciences
Full name of responsible person
Masoomeh Nasehi
Position
Master of Midwifery / Midwife
Other areas of specialty/work
Street address
End of Jahad street Adjacent to emergency, Urmia, West Azarbayejan, Iran .
City
Urmia
Postal code
57147-83734
Phone
00984413467915 - 00984413456295
Fax
...
Email
Masoomehnasehi@gmail.com ; Nasehi_m@Umsu.ac.ir
Web page address
Logistic@Umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Masoomeh Nasehi
Position
Master of Midwifery
Other areas of specialty/work
Street address
Urmia University of Medical Sciences, End of jahad street Next Emergency, Urmia, West Azarbayijan, Iran.
City
Urmia
Postal code
57147-83734
Phone
00984413369482 - 00984413456295
Fax
....
Email
Masoomehnasehi@gmail.com ; Nasehi_M@Umsu.ac.ir
Web page address
Logistic @ umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Masoomeh Nasehi
Position
Master of Midwifery
Other areas of specialty/work
Street address
Urmia University of Medical Sciences, End of Jahd Street next Emergency, Urmia, West Azarbayejan, Iran.
City
Urmia
Postal code
57147-83734
Phone
00984413467915 - 00984413456295
Fax
...
Email
Masoomehnasehi@gmail.com ; Nasehi_m@Umsu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)