Status:
COMPLETED
Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients
Lead Sponsor:
Xuanwu Hospital, Beijing
Collaborating Sponsors:
Ministry of Health, China
Michael J. Fox Foundation for Parkinson's Research
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
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 a...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00461942
Start Date
April 1 2006
End Date
March 1 2009
Last Update
August 16 2011
Active Locations (1)
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1
Beijing Institute of Geriatrics, Xuanwu Hospital
Beijing, China, 100053