Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Fibrocystic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Oncoxin, a nutritional supplement

Group Type EXPERIMENTAL

Oncoxin

Intervention Type DIETARY_SUPPLEMENT

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

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Oncoxin

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No