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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461942
• Other study ID #: 2004BA702B02-2
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2007
• Last updated: August 15, 2011
• Start date: April 2006
• Est. completion date: March 2009

Study information

• Verified date: August 2011
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Green Tea Polyphenols (EGCG/ECG)

Locations

Country	Name	City	State
China	Beijing Institute of Geriatrics, Xuanwu Hospital	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	Michael J. Fox Foundation for Parkinson's Research, Ministry of Health, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delay of progression of Motor dysfunction
Secondary	Cognition;
Secondary	Mood;
Secondary	Quality of Daily life