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

Phase 2CompletedNCT00461942

Xuanwu Hospital, Beijing480 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

480

Conditions

Parkinson's Disease

Interventions

Green Tea Polyphenols (EGCG/ECG)DRUG

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Institute of Geriatrics, Xuanwu Hospital

Beijing, China

Outcomes

Primary Outcomes

Delay of progression of Motor dysfunction

Secondary Outcomes

Cognition;

Mood;

Quality of Daily life

Data from ClinicalTrials.gov

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