Breast Fibrocystic Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOncoxin
(caplets 300 mg), three oral caplets per day for 24 weeks
DIETARY_SUPPLEMENTPlacebo
(caplets 300 mg), three oral caplets per day for 24 weeks
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with clinical and ultrasonographic confirmation of breast fibrocystic disease. * Patients older than 20 years. * Female patients. * Informed consent.
Exclusion criteria
* Presents of another disease not well controlled. * Pregnant women or lactating. * Patient which are receiving another products from other investigations trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ultrasonographic improvement at 24 weeks (end of the treatment) | 24 weeks |
| Adverse effects at 24 weeks (end of the treatment) | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Lesion size according clinical measurement at 24 weeks (end of the treatment) | 24 weeks |
| Pain according patient examination at 24 weeks (end of the treatment) | 24 weeks |
Countries
Cuba
Outcome results
None listed