Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Green Tea Polyphenols (EGCG/ECG)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No