NCT00461942

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

August 16, 2011

Status Verified

August 1, 2011

First QC Date

April 17, 2007

Last Update Submit

August 15, 2011

Conditions

Parkinson's Disease

Keywords

Health Food;Green Tea;Neuroprotection

Outcome Measures

Primary Outcomes (1)

  • Delay of progression of Motor dysfunction

Secondary Outcomes (3)

  • Cognition;

  • Mood;

  • Quality of Daily life

Interventions

Green Tea Polyphenols (EGCG/ECG)DRUG

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Institute of Geriatrics, Xuanwu Hospital

Beijing, 100053, China

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Tea

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Piu Chan, MD, PhD

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2007

First Posted

April 18, 2007

Study Start

April 1, 2006

Study Completion

March 1, 2009

Last Updated

August 16, 2011

Record last verified: 2011-08

Locations

CN(1)