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OpenTrials
Completed

NCT Number: NCT00967681

Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease

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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Key information

Conditions

Breast Fibrocystic Disease Breast Diseases Fibrocystic Breast Disease Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

"Ramón González Coro" Gynecologic and Obstetric Hospital

Havana, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oncoxin

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. The ultrasonographic improvement at 24 weeks (end of the treatment)

    Time frame: 24 weeks

  2. Adverse effects at 24 weeks (end of the treatment)

    Time frame: 24 weeks

Secondary outcomes

  1. Lesion size according clinical measurement at 24 weeks (end of the treatment)

    Time frame: 24 weeks

  2. Pain according patient examination at 24 weeks (end of the treatment)

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

Efficacy and Safety of Nutritional Supplement ONCOXIN in Patients With Breast Fibrocystic Disease

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 28, 2009
Registry last updated
May 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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