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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00461942
First Posted: April 18, 2007
Last Update Posted: August 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ministry of Health, China
Michael J. Fox Foundation for Parkinson's Research
Information provided by:
Xuanwu Hospital, Beijing
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00461942     History of Changes
Other Study ID Numbers: 2004BA702B02-2
First Submitted: April 17, 2007
First Posted: April 18, 2007
Last Update Posted: August 16, 2011
Last Verified: August 2011

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