Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease

Catalysis SL200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Breast Fibrocystic Disease

Interventions

OncoxinDIETARY_SUPPLEMENT

(caplets 300 mg), three oral caplets per day for 24 weeks

PlaceboDIETARY_SUPPLEMENT

(caplets 300 mg), three oral caplets per day for 24 weeks

Eligibility

Sex: FEMALEMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

"Ramón González Coro" Gynecologic and Obstetric Hospital

Havana, La Habana, Cuba

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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