Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson`s Disease

Parkinson`s Disease Clinical Trial

Official title:

Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson`s Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01016470
• Other study ID #: CAT-0916-CU
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2009
• Last updated: May 2, 2012
• Start date: October 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2012
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate whether Viusid/Alzer Nutritional supplements, could improve the progression disease, in patients with Parkinson's Disease (PD).

Description:

Periodical measures of the clinical features with UPDRS will be done at the beginning, each three months until two years. Each group will be compare to evaluate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with clinical of PD, with the criteria of Brain Bank of London with early stage.

• Informed consent.

Exclusion Criteria:

• Presence of another disease not well controlled.

• Patient with atypical features.

• Patient with advanced Parkinson`s disease.

Study Design

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson`s Disease

Intervention

Dietary Supplement:
• VIUSID/ALZER
VIUSID/ALZER, 3 per day, oral, one year
• Placebo
Placebo Viusid and Placebo Alzer, 3 per day, oral, one year

Locations

Country	Name	City	State
Cuba	"Salvador Allende Hospital"	Havana City	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periodical measures of the clinical features with Unified Parkinson Disease Rating Scale (UPDRS) will be done at the beginning, every three months until one year (end of the treatment)		one year	Yes
Secondary	Hoehn-Yarh will be done at the beginning, every three months until one year (end of the treatment)		one year	Yes
Secondary	Dosage levodopa will be done at the beginning, every three months until one year (end of the treatment)		one year	Yes

External Links

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