Comparison effect of Fennel/Vitamin E and Ibuprofen on intensity of Primary dysmenorrhea at students of Tabriz, 2007-2009

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2011
INTERVENTION: 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 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 CONDITION: N94 Pain and other conditions associated with female genital organs and menstrual cycle N94.4 Pr Primary dysmenorrhoea. ; N94 Pain and other conditions associated with female genital organs and menstrual cycle PRIMARY OUTCOME: 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 OUTCOME: ‐‐‐. Timepoint: ‐‐‐‐‐‐‐‐‐‐‐. Method of measurement: ‐‐‐‐‐‐‐‐‐‐‐. 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
Epistemonikos ID: dc7620f900653d817117bbd9c7857cf30d43544b
First added on: Aug 22, 2024