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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00461942

Enrollment

480

Registered

2007-04-18

Start date

2006-04-30

Completion date

2009-03-31

Last updated

2011-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Health Food;, Green Tea;, Neuroprotection

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.

Interventions

DRUGGreen Tea Polyphenols (EGCG/ECG)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Delay of progression of Motor dysfunction	—

Secondary

Measure	Time frame
Cognition;	—
Mood;	—
Quality of Daily life	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026