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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

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

NCT ID

NCT01016470

First Posted

September 28, 2009

Last Updated

May 2, 2012

Sponsor

Catalysis SL

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

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

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

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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