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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01016470
First Posted: November 19, 2009
Last Update Posted: May 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Catalysis SL
  Purpose
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).

Condition Intervention Phase
Parkinson`s Disease Dietary Supplement: VIUSID/ALZER Dietary Supplement: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson`s Disease

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • 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) [ Time Frame: one year ]

Secondary Outcome Measures:
  • Hoehn-Yarh will be done at the beginning, every three months until one year (end of the treatment) [ Time Frame: one year ]
  • Dosage levodopa will be done at the beginning, every three months until one year (end of the treatment) [ Time Frame: one year ]

Enrollment: 100
Study Start Date: October 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: B
Placebo
Dietary Supplement: Placebo
Placebo Viusid and Placebo Alzer, 3 per day, oral, one year
Experimental: A
VIUSID/ALZER. The purpose of the study is to evaluate whether Viusid/Alzer Nutritional supplements, could improve the progression disease, in patients with early PD by UPDRS motor
Dietary Supplement: VIUSID/ALZER
VIUSID/ALZER, 3 per day, oral, one year

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016470


Locations
Cuba
"Salvador Allende Hospital"
Havana City, Havana, Cuba
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Jose Luis Guiroud, PhD "Salvador Allende" Hospital
  More Information

Additional Information:
Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT01016470     History of Changes
Other Study ID Numbers: CAT-0916-CU
First Submitted: September 28, 2009
First Posted: November 19, 2009
Last Update Posted: May 4, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases