Study on effects of black seed oil in treatment of cyclic mastalgia

INTERVENTION: Diclofenac gel is used at the dose of 20 mg topically on the site of breast pain twice daily in 50 patients for 2 months Intervention 1: Nigella sativa seed oil gel is used at the dose of 600 mg topically on the site of breast pain twice daily in 50 patients for 2 months. Intervention 2: Diclofenac gel is used at the dose of 20 mg topically on the site of breast pain twice daily in 50 patients for 2 months. Intervention 3: Placebo gel is used topically on the site of breast pain twice daily in 50 patients for 2 months. Nigella sativa seed oil gel is used at the dose of 600 mg topically on the site of breast pain twice daily in 50 patients for 2 months Placebo gel is used topically on the site of breast pain twice daily in 50 patients for 2 months Treatment ‐ Drugs CONDITION: Mastalgia. ; Mastodynia Mastodynia PRIMARY OUTCOME: Pain severity score. Timepoint: Before, 1 and 2 months after beginning of the intervention. Method of measurement: 10 centimeter visual analog scale. SECONDARY OUTCOME: Adverse drug reactions. Timepoint: 1 and 2 months after beginning of the intervention. Method of measurement: Patient report. INCLUSION CRITERIA: INCLUSION CRITERIA: Iranian outpatient females with cyclic mastalgia, patients aged 25‐45 years; patients with regular menstrual cycles; patients with cyclic mastalgia diagnosis based on history of cyclic mastalgia for at least the past 3 consecutive cycles, patients with pain duration of at least 7 days per month and mastalgia severity score greater than 4 on a 10 centimeter visual analogue scale requiring pharmacotherapy. Exclusion criteria: Patients receiving hormone therapy or hormonal contraceptive; patients with irregular menstrual cycles; patients with history of breast and endometrial cancer, hysterectomy and bilateral oophorectomy; pregnanct women; brest‐feeding women; women planning pregnancy; women with serious health problems.