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

Capital Medical University

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: Green Tea Polyphenols (EGCG/ECG)

Study type: Interventional

Funder types: Other

Identifiers

NCT00461942

2004BA702B02-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind