Back to resultsEfficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Green Tea Polyphenols (EGCG/ECG)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Health Food;, Green Tea;, Neuroprotection
Eligibility Criteria
Inclusion Criteria:
- Willing and able to give informed consent
- Age 30 years or older at time of diagnosis of Parkinson's disease
- Diagnosed as having typical PD
- Parkinson's disease duration of no more than 5 years
- No current dopaminergic or other forms of anti-parkinsonism therapy
- Hoehn and Yahr stage < 3
Sites / Locations
- Beijing Institute of Geriatrics, Xuanwu Hospital
Outcomes
Primary Outcome Measures
Delay of progression of Motor dysfunction
Secondary Outcome Measures
Cognition;
Mood;
Quality of Daily life
Full Information
NCT ID
NCT00461942
First Posted
April 17, 2007
Last Updated
August 15, 2011
Sponsor
Xuanwu Hospital, Beijing
Collaborators
Ministry of Health, China, Michael J. Fox Foundation for Parkinson's Research
1. Study Identification
Unique Protocol Identification Number
NCT00461942
Brief Title
Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Neuroprotection Effect of Green Tea Polyphenol in De Novo Parkinson's Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Xuanwu Hospital, Beijing
Collaborators
Ministry of Health, China, Michael J. Fox Foundation for Parkinson's Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether Green Tea Polyphenol, an extraction from Green Tea is effective and safe in the treatment of De Novo Parkinson's disease Patients without taking any antiparkinsonism drug
Detailed Description
The primary outcome measurement is UPDRS using a delay start design. Total 480 de novo PD patients divided into three dosage groups of green tea polyphenol and one placebo control group. Patients will be treated for one year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Health Food;, Green Tea;, Neuroprotection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Green Tea Polyphenols (EGCG/ECG)
Primary Outcome Measure Information:
Title
Delay of progression of Motor dysfunction
Secondary Outcome Measure Information:
Title
Cognition;
Title
Mood;
Title
Quality of Daily life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing and able to give informed consent
Age 30 years or older at time of diagnosis of Parkinson's disease
Diagnosed as having typical PD
Parkinson's disease duration of no more than 5 years
No current dopaminergic or other forms of anti-parkinsonism therapy
Hoehn and Yahr stage < 3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piu Chan, MD, PhD
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Institute of Geriatrics, Xuanwu Hospital
City
Beijing
ZIP/Postal Code
100053
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients
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