â??Centchroman versus Tamoxifen in Symptomatic benign breast disease. Randomized clinical trialâ??

Intra Mural Grant from All India Institute of Medical Sciences New Delhi0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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 ( < 3cm), fibrosis, hyperplasia and metaplasia.
•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

•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

发起方

Intra Mural Grant from All India Institute of Medical Sciences New Delhi