A Randomised Double Blind Placebo Controlled Clinical Trial of Centchroman (Saheli) in breast pain and nodularity (Benign Breast Disorders)
Phase 3
Completed
- Conditions
- Health Condition 1: null- Benign Breast non discrete nodularity and pain
- Registration Number
- CTRI/2008/091/000279
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 140
Inclusion Criteria
women (age group of 20-50 years with cyclical/non-cyclical breast pain and nodularity of more than three months duration.) attending the outpatient Departments of Surgery and Obstetrics and Gynecology and a specially established Breast Clinic at the Queen Mary?s Hospital, Lucknow
Exclusion Criteria
Patients with a discrete mass will be excluded if suspicious of cancer. Patients taking an alternative treatment will be excluded from the study. Those planning for pregnancy and are on some other oral contraceptive pills will not be registered for this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement as assessed by daily breast pain chart and linear analogue scale will be the main outcome factor. Success will be defined as 50% reduction in the mean breast nodularity and pain score.Timepoint: The clinical examination will be done at 1, 2, 3 months while still on the drug or placebo and 4, 6 months after stopping the drug or placebo
- Secondary Outcome Measures
Name Time Method ilTimepoint: The clinical examination will be done at 1, 2, 3 months while still on the drug or placebo and 4, 6 months after stopping the drug or placeboNone