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

Phase 2

• Conditions: Primary dysmenorrhoea.; N94 Pain and other conditions associated with female genital organs and menstrual cycle; N94.4 Pr

• Registration Number: IRCT201101225664N1
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 68

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
---. Timepoint: -----------. Method of measurement: -----------.