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

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, China
Michael J. Fox Foundation for Parkinson's Research
Information provided by:
Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier:
NCT00461942
First received: April 17, 2007
Last updated: August 15, 2011
Last verified: August 2011
History of Changes
  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
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:

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: 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 June 18, 2013