Health Condition 1: D249- Benign neoplasm of unspecified breast Health Condition 2: N602- Fibroadenosis of breast Health Condition 3: N604- Mammary duct ectasia Health Condition 4: N610- Mastitis without abscess
Conditions
Interventions
Intervention1: Centchroman and Metformin: comparing outcomes in terms of reduction of VAS score and USG lesion reduction in two groups as compared to comparator agent
group 2-Centchroman (Ormeloxife
Sponsors
All India Institute of Medical Sciences Gorakhpur
Eligibility
Inclusion criteria
Inclusion criteria: Women of 14 years after attaining menarche, till 45 years of age- premenopausal Clinically and radiologically diagnosed BBD (mastalgia,fibroadenosis,fibrocystic disease or fibroadenomas less than 5cm ) BI-RADS 1-4 on ultrasonography with histological evidence of benign breast disease.
Exclusion criteria
Exclusion criteria: Histologically proven malignancy in FNAC or biopsy Pregnant or lactating women. Known hypersensitivity to any study drug. On hormonal therapy in the last 3 months. Known diabetes mellitus or liver and or renal gross dysfunction.(more than twice the normal range)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean reduction in VAS pain score at 6 weeks and 12 weeks and mean lesion reduction on ultrasound at 12 weeks Timepoint: 6 weeks and 12 weeks for VAS SCORE 12 weeks for USG LESION | — |
Secondary
| Measure | Time frame |
|---|---|
| correction in hormonal profile in 3 groups - oestradiol, progesterone, prolactinTimepoint: 12 weeks;rate of Recurrence at 6 months in three groups.Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Dharmendra kumar pipal
All India Institute Of Medical Sciences, Gorakhpur
Outcome results
None listed