Health Condition 1: D249- Benign neoplasm of unspecified breast
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Female patient within the age group of 18-50 years Participants irrespective of marital status and parit Participants presenting the classical symptoms like MruduChala AlparujaShopha Participants with symptoms of fibroadenoma Palpable breast lump consistent with fibroadenoma on clinical examination mobile well circumcised firm or rubbery non-tender A lump with or without pain Mammography findings fibroadenoma over well defined, hypoechoic mass in sonomammograph Size of lesion less than or equal to 2 cm for observation Non suspicious feature (BIRADS-0,1 and 2)
Exclusion criteria
Exclusion criteria: Subjects who are pregnant and lactating mothers. Suspicion of malignancy on clinical or imaging findings. Irregular poorly, hard fixed, defined mass. Skin dimpling, nipple retraction. Nipple discharge in one or both breast. BIRADS 3,4 and 5 on imaging. Subjects with giant and juvenile fibroadenoma with h/o breast malignancy/surgery. Subjects with breast implants in the target breast. Subjects with breast cyst within fibroadenoma, mastitis, phylloids tumor, breast abscess. Subjects participating in another clinical trial involving investigational drug device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Change in volume of fibroadenoma -Fibroadenoma volume will be measured by Sonomammagraphy Baseline is 2 months Follow up after 3 months 2)Size of fibroadenomaFibroadenoma will be assessed by physical examination including measurement of tumor size at clinical visits. 3)Patient reported outcomes Secondary outcome Outcome MeasureMeasure Description Time Frame Incidence of adverse events Incidence of rash, itching etc-Upto 2 months Timepoint: Baseline 2 months follow up after 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient reported outcomes Patient rated pain and patient responses to satisfaction questionnaire will be measured at intervals up to 2 months. Up to 3 months Secondary outcome Outcome Measure Measure Description Time Frame Incidence of adverse events Incidence of rash, itching etc-Upto 2 months Timepoint: total study duration-60 days Pre assessment 0th day 1st assessment 60 th day Follow up 90 th day | — |
Countries
India
Contacts
Sri Sri College of Ayurvedic Science and Research