Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00461942
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : August 16, 2011
Sponsor:
Collaborators:
Ministry of Health, China
Michael J. Fox Foundation for Parkinson's Research
Information provided by:
Xuanwu Hospital, Beijing

Tracking Information
First Submitted Date  ICMJE April 17, 2007
First Posted Date  ICMJE April 18, 2007
Last Update Posted Date August 16, 2011
Study Start Date  ICMJE April 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2007)
Delay of progression of Motor dysfunction
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2007)
  • Cognition;
  • Mood;
  • Quality of Daily life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients
Official Title  ICMJE 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
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Drug: Green Tea Polyphenols (EGCG/ECG)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 17, 2007)
480
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00461942
Other Study ID Numbers  ICMJE 2004BA702B02-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Xuanwu Hospital, Beijing
Collaborators  ICMJE
  • Ministry of Health, China
  • Michael J. Fox Foundation for Parkinson's Research
Investigators  ICMJE
Principal Investigator: Piu Chan, MD, PhD Xuanwu Hospital, Beijing
PRS Account Xuanwu Hospital, Beijing
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP