Efficacy and Safety of Green Tea Polyphenol in De Novo Pa... | NCT00461942

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

NCT00461942

Sponsor

Xuanwu Hospital, Beijing

Status

Completed

Last Update Posted

Aug 16, 2011Estimated

Enrollment

480Estimated

Phase

Phase 2

Conditions

Parkinson's Disease

Interventions

Green Tea Polyphenols (EGCG/ECG)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Mar 2009Actual

First Submitted Date

Apr 17, 2007

First Submission Date that Met QC Criteria

Apr 17, 2007

First Posted Date

Apr 18, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2011

Last Update Posted Date

Aug 16, 2011Estimated

Name	Class
Ministry of Health, China	OTHER_GOV
Michael J. Fox Foundation for Parkinson's Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

480Estimated

Name	Type	Description	Arm Group Labels	Other Names
Green Tea Polyphenols (EGCG/ECG)	Drug

Measure	Description	Time Frame
Delay of progression of Motor dysfunction

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Piu Chan, MD, PhD	Xuanwu Hospital, Beijing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Institute of Geriatrics, Xuanwu Hospital		Beijing		100053	China

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013662	Tea

Ancestor Terms

ID	Term
D028321	Plant Preparations
D001688	Biological Products
D045424	Complex Mixtures
D001628	Beverages

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Cognition;
Mood;
Quality of Daily life