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

This study has been completed.

First Received on April 17, 2007. Last Updated on August 15, 2011 History of Changes

Sponsor:	Xuanwu Hospital, Beijing
Collaborators:	Ministry of Health, China Michael J. Fox Foundation for Parkinson's Research
Information provided by:	Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier:	NCT00461942

Purpose

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

Condition	Intervention	Phase
Parkinson's Disease	Drug: Green Tea Polyphenols (EGCG/ECG)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Xuanwu Hospital, Beijing:

Primary Outcome Measures:

Delay of progression of Motor dysfunction

Secondary Outcome Measures:

Cognition;
Mood;
Quality of Daily life

Estimated Enrollment:	480
Study Start Date:	April 2006
Study Completion Date:	March 2009

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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461942

Locations

China
Beijing Institute of Geriatrics, Xuanwu Hospital
Beijing, China, 100053

Sponsors and Collaborators

Xuanwu Hospital, Beijing

Ministry of Health, China

Michael J. Fox Foundation for Parkinson's Research

Investigators

Principal Investigator:

Piu Chan, MD, PhD

Xuanwu Hospital, Beijing

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00461942 History of Changes
Other Study ID Numbers:	2004BA702B02-2
Study First Received:	April 17, 2007
Last Updated:	August 15, 2011
Health Authority:	China: State Food and Drug Administration

Keywords provided by Xuanwu Hospital, Beijing:

Health Food;
Green Tea;
Neuroprotection

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on February 09, 2012