Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients
August 15, 2011 updated by: Xuanwu Hospital, Beijing
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
480
Phase
- Phase 2
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
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Beijing, China, 100053
- Beijing Institute of Geriatrics, Xuanwu Hospital
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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
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Delay of progression of Motor dysfunction
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Secondary Outcome Measures
Outcome Measure |
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Cognition;
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Mood;
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Quality of Daily life
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Piu Chan, MD, PhD, Xuanwu Hospital, Beijing
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
April 1, 2006
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
April 17, 2007
First Submitted That Met QC Criteria
April 17, 2007
First Posted (Estimate)
April 18, 2007
Study Record Updates
Last Update Posted (Estimate)
August 16, 2011
Last Update Submitted That Met QC Criteria
August 15, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004BA702B02-2
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.