Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease

Breast Fibrocystic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967681
• Other study ID #: CAT-0901-CU
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2009
• Last updated: May 2, 2012
• Start date: September 2009
• Est. completion date: April 2011

Study information

• Verified date: May 2012
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Scientific and Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Fibrocystic Disease
• Cystic Fibrosis

Intervention

Dietary Supplement:
• Oncoxin
(caplets 300 mg), three oral caplets per day for 24 weeks
• Placebo
(caplets 300 mg), three oral caplets per day for 24 weeks

Locations

Country	Name	City	State
Cuba	"Ramón González Coro" Gynecologic and Obstetric Hospital	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ultrasonographic improvement at 24 weeks (end of the treatment)		24 weeks	No
Primary	Adverse effects at 24 weeks (end of the treatment)		24 weeks	Yes
Secondary	Lesion size according clinical measurement at 24 weeks (end of the treatment)		24 weeks	No
Secondary	Pain according patient examination at 24 weeks (end of the treatment)		24 weeks	No