Clinical Trial: Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy and Safety of Nutritional Supplement ONCOXIN in Patients With Breast Fibrocystic Disease
Brief Summary: The purpose of the study is to evaluate whether Oncoxin, a nutritional supplement, improves the clinical and ultrasonographic results in comparison with placebo during 24 weeks of treatment.
Detailed Summary:
Sponsor: Catalysis SL
Current Primary Outcome:
- The ultrasonographic improvement at 24 weeks (end of the treatment) [ Time Frame: 24 weeks ]
- Adverse effects at 24 weeks (end of the treatment) [ Time Frame: 24 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Lesion size according clinical measurement at 24 weeks (end of the treatment) [ Time Frame: 24 weeks ]
- Pain according patient examination at 24 weeks (end of the treatment) [ Time Frame: 24 weeks ]
Original Secondary Outcome: Same as current
Information By: Catalysis SL
Dates:
Date Received: August 27, 2009
Date Started: September 2009
Date Completion:
Last Updated: May 2, 2012
Last Verified: May 2012