Primary dysmenorrhoea. N94 Pain and other conditions associated with female genital organs and menstrual cycle
Conditions
Interventions
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.
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
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| ---. Timepoint: -----------. Method of measurement: -----------. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMasoomeh Nasehi
Urmia University of Medical Sciences
Outcome results
None listed