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OpenTrials
Completed

NCT Number: NCT01016470

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

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).

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

"Salvador Allende Hospital"

Havana, La Habana, Cuba

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

VIUSID/ALZER

Dietary Supplement

VIUSID/ALZER, 3 per day, oral, one year

Placebo

Dietary Supplement

Placebo Viusid and Placebo Alzer, 3 per day, oral, one year

Primary outcomes

  1. 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 outcomes

  1. Hoehn-Yarh will be done at the beginning, every three months until one year (end of the treatment)

    Time frame: one year

  2. Dosage levodopa will be done at the beginning, every three months until one year (end of the treatment)

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 19, 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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