The effect of ethanol extract of Iranian borage on menstrual pain intensity and quality of life enjoyment and satisfaction of students
Phase 2
- Conditions
- primary dysmenorrheaprimary dysmenorrhea.
- Registration Number
- IRCT201601143706N28
- Lead Sponsor
- Vice chancellor for research, Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 70
Inclusion Criteria
1) single; 2) age between 18 and 30 years; 3) regular menstrual periods with interval of 21 to 35 days; 4) moderate to severe menstrual pain (above 4.4 mm in 10 cm VAS) over the past 6 months; 5) lack of heavy menstrual bleeding
Exclusion criteria: 1) any sensitivity to herbal medicines; 2) smoking or alcohol drinking; 3) any known chronic diseases; 4) no easy access to telephone line for the follow-ups
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of Life Enjoyment and Satisfaction. Timepoint: 1) one cycle before intervention 2) The third cycle after intervention. Method of measurement: Quality of Life Enjoyment and Satisfaction questionnaire.;Number of Gelofen used. Timepoint: 1) one cycle before intervention 2) The first , second and third cycles after intervention. Method of measurement: Visual analogue scale (VAS) for pain.;Menstural pain intensity. Timepoint: 1) one cycle before intervention 2) The first, second and third cycles after intervention. Method of measurement: Visual Analog scale ((VAS?0-10).
- Secondary Outcome Measures
Name Time Method Menstural Symptom Severity. Timepoint: 1)one cycle before intervention 2) The first cycle, the second and third after intervention. Method of measurement: Symptom Severity Scale.;Menstrual blood loss. Timepoint: 1)one cycle before intervention 2) The first cycle, second and third cycles after intervention. Method of measurement: Chart Higham.;Side effects. Timepoint: The first cycle, the second and third after intervention. Method of measurement: Self report on a diary.;Satisfaction with treatment. Timepoint: The first cycle, the second and third after intervention. Method of measurement: self report- one likert question.