Trial | NCT00461942  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    480
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
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 Started
Apr 30
2006
Study Completion
Mar 31
2009
Last Update
Aug 16
2011
Estimate

Drug Green Tea Polyphenols (EGCG/ECG)

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
No Results Posted