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

May 2, 2012 updated by: Catalysis SL
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
    • Havana
      • Havana City, Havana, Cuba
        • "Salvador Allende Hospital"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Investigators

  • Principal Investigator: Jose Luis Guiroud, PhD, "Salvador Allende" Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 28, 2009

First Submitted That Met QC Criteria

November 18, 2009

First Posted (Estimate)

November 19, 2009

Study Record Updates

Last Update Posted (Estimate)

May 4, 2012

Last Update Submitted That Met QC Criteria

May 2, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT-0916-CU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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