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OpenTrials
Completed

NCT Number: NCT00461942

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

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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Institute of Geriatrics, Xuanwu Hospital

Beijing, 100053, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Green Tea Polyphenols (EGCG/ECG)

Drug

Primary outcomes

  1. Delay of progression of Motor dysfunction

Secondary outcomes

  1. Cognition;

  2. Mood;

  3. Quality of Daily life

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • Michael J. Fox Foundation for Parkinson's Research
  • Ministry of Health, China

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2009
First posted
Apr 18, 2007
Registry last updated
Aug 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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