Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
Cuba
Study Type
Interventional
Intervention
VIUSID/ALZER
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility 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.
Sites / Locations
- "Salvador Allende Hospital"
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
B
A
Arm Description
Placebo
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
Outcomes
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)
Secondary Outcome Measures
Hoehn-Yarh will be done at the beginning, every three months until one year (end of the treatment)
Dosage levodopa will be done at the beginning, every three months until one year (end of the treatment)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01016470
Brief Title
Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson's Disease
Official Title
Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalysis SL
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
A
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
VIUSID/ALZER
Intervention Description
VIUSID/ALZER, 3 per day, oral, one year
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo Viusid and Placebo Alzer, 3 per day, oral, one year
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Hoehn-Yarh will be done at the beginning, every three months until one year (end of the treatment)
Time Frame
one year
Title
Dosage levodopa will be done at the beginning, every three months until one year (end of the treatment)
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Luis Guiroud, PhD
Organizational Affiliation
"Salvador Allende" Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Salvador Allende Hospital"
City
Havana City
State/Province
Havana
Country
Cuba
12. IPD Sharing Statement
Links:
URL
http://www.catalysis.es
Description
Related Info
Learn more about this trial
Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson's Disease
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