Comparison of the effects of Evening Primrose and Vitamin B6 on the severity of mastalgia associated with fibrocystic breast changes.
Not Applicable
- Conditions
- Fibrocystic changes of breast.Benign mammary dysplasia
- Registration Number
- IRCT2016062128574N1
- Lead Sponsor
- Vice chancellor for research, Iran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 96
Inclusion Criteria
Inclusion criteria : Iranian women aged 18 to 50 years before menopause; non-pregnant women; non-lactating women; women with mastalgi; rejection of cancer and other breast diseases based on clinical and laboratory evidence by specialist in surgery and breast diseases; not taking medications to reduce pain (eg Danazol, Tamoxifen, Bromocriptine) during the past three months. Exclusion criteria: pregnancies; physical or mental illness during intervention; taking any herbal or chemical or hormonal drugs during the study; unwillingness to continue taking the medication as directed; no medicine use more than 5 days
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The severity of mastalgia. Timepoint: Before the intervention, one month and two months and three months after intervention. Method of measurement: Visual analog scale questionnaires.
- Secondary Outcome Measures
Name Time Method umber of days with pain. Timepoint: Before the intervention, one month and two months and three months after intervention. Method of measurement: Daily record pain questionnaire.