Health Condition 1: null- Breast pain and breast lump that are FNAC or biopsy proven benign breast lump less than 2.5cm.
Conditions
Interventions
Intervention1: Centchroman: Centchroman 30 mg daily orally
for 3 months
Control Intervention1: Tamoxifen: Tamoxifen 10 mg orally daily for three months
Sponsors
Intra Mural Grant from All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. All women (18years and older) with mastalgia with VAS score > 3 lasting for more than 3 months 2.Clinical, radiographic and histological (breast lump / sonological visible lesion) diagnosis of benign breast disease. 3.Benign breast disease such as adenosis, cyst, duct ectasia, fibrocystic disease, fibro-adenoma ( 4.Normal liver function test, complete blood count, renal function test. 5.No deep vein thrombosis or No pulmonary embolus or No cerebral vascular accident, transient ischemic attack, atrial fibrillation, or uncontrolled hypertension 6.No history of prior malignancy within the past 5 years 7.No clinical depression, psychiatric condition, or addictive disorder
Exclusion criteria
Exclusion criteria: 1.Age less than 18 years or more than 65 years 2.Benign breast lesions which require surgery for Cosmesis. 3.Fibro adenoma more than or equal to 2.5 cm. 4.Acute Inflammatory breast lesions which are amenable to antibiotic therapy or surgical drainage 5.Past history of breast carcinoma or family history of breast carcinoma 6.Patients with polycystic ovarian diseases and cervical hyperplasia / chronic cervicitis 7.Oligomenorrhoea and irregular menstrual bleeding 8.Tuberculosis, renal disease and hypersensitivity to centchroman or tamoxifen 9.Pregnancy or planning to conceive. 10.Lactation of initial 6 months duration 11.Patients unwilling to undergo treatment or not willing to consent for the study 12.High risk breast lesions like epitheliosis, atypia or atypical hyperplasia or evidence of malignancy on histopathology or susceptible lesions prone to develop malignancy on ultrasonography
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| is to determine the efficacy of regimens in the participants in each group 1 Reduction of mastalgia cyclical and non-cyclical or heaviness discomfort by 80 per cent reduction of pain to less than or equal to 3 on VAS 2 Reduction in Lump Size or nodularity by 50 percent documented by Ultrasonography of the breast for quantitative analysis of FNAC or biopsy proven non-malignant or benign lesion of breast Timepoint: 4 weeks 8 weeks 12 weeks 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tolerability means the toxic effects or side effect or Adverse drug reactions of regimens in the participants in each group 2. Cost effectiveness means saving of time and money by reduction in Number of OPD visits or reduction in cost or saving of time Timepoint: 24 Weeks | — |
Countries
India
Contacts
Public ContactManjunath Maruti Pol
All India Institute of Medical Science New Delhi
Outcome results
None listed