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IRCT201101225664N1 IRCT 2011-08-26 Tabriz University of Medical Sciences Comparison effect of Fennel/Vitamin E and Ibuprofen on intensity of Primary dysmenorrhea at students of Tabriz, 2007-2009. Comparison effect of Fennel/Vitamin E and Ibuprofen on intensity of primary dysmenorrhea at students of Tabriz, 2007-2009. 2008-09-22 anticipated 68 Complete https://irct.ir/trial/6176 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment. 2 Primary dysmenorrhoea. Intervention 1: Cap 500 mg ( 60 mg Fennel extract / 150 UI Vitamin E ) QID N=1 at first two day of menstration. Intervention 2: Cap Ibuprofen 400 mg QID N=1 at first two day of menstration.
public Masoomeh Nasehi
End of Jahad street Adjacent to emergency, Urmia, West Azarbayejan, Iran .
Urmia Iran (Islamic Republic of) 57147-83734 00984413467915 - 00984413456295 Masoomehnasehi@gmail.com ; Nasehi_m@Umsu.ac.ir Urmia University of Medical Sciences scientific Masoomeh Nasehi
Urmia University of Medical Sciences, End of jahad street Next Emergency, Urmia, West Azarbayijan, Iran.
Urmia Iran (Islamic Republic of) 57147-83734 00984413369482 - 00984413456295 Masoomehnasehi@gmail.com ; Nasehi_M@Umsu.ac.ir Urmia University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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. no limit no limit Female N94.4 Pr N94 Pain and other conditions associated with female genital organs and menstrual cycle Treatment - Drugs Treatment - Drugs Cap 500 mg ( 60 mg Fennel extract / 150 UI Vitamin E ) QID N=1 at first two day of menstration Cap Ibuprofen 400 mg QID N=1 at first two day of menstration 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). ---. Timepoint: -----------. Method of measurement: -----------. - - Tabriz University of Medical Sciences Approved 2008-10-26 Tabriz University of Medical Sciences Tabriz University of Medical, Golgasht street, Tabriz, Iran. Tabriz Iran (Islamic Republic of)