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

This study is currently recruiting participants.

Verified by Xuanwu Hospital, Beijing, April 2007

First Received: April 17, 2007 No Updates Released

Sponsors and Collaborators:	Xuanwu Hospital, Beijing 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

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

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Crossover Assignment, Double-Blind, Placebo Control, Randomized, Safety/Efficacy Study, 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

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
Estimated Study Completion Date:	October 2008

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

Contacts

Contact: Zhaohui Qin, MD

8+86-10-83161294

Locations

China
Beijing Institute of Geriatrics, Xuanwu Hospital	Recruiting
Beijing, China, 100053
Contact: Zhaohui Qin, MD +86-10-83161294
Principal Investigator: Piu Chan, MD PhD

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

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

Keywords provided by Xuanwu Hospital, Beijing:

Green Tea;
Health Food;
Neuroprotection

Study placed in the following topic categories:

Signs and Symptoms
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on March 16, 2009