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

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ClinicalTrials.gov Identifier: NCT00461942
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : August 16, 2011
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Study Description
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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Green Tea Polyphenols (EGCG/ECG) Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
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
Study Start Date : April 2006
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Delay of progression of Motor dysfunction

Secondary Outcome Measures :
  1. Cognition;
  2. Mood;
  3. Quality of Daily life

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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
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 Posted: April 18, 2007    Key Record Dates
Last Update Posted: August 16, 2011
Last Verified: August 2011

Keywords provided by Xuanwu Hospital, Beijing:
Health Food;
Green Tea;

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases