Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients
Phase 2
Completed
- Conditions
- Parkinson's Disease
- Registration Number
- NCT00461942
- Lead Sponsor
- Xuanwu Hospital, Beijing
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Delay of progression of Motor dysfunction
- Secondary Outcome Measures
Name Time Method Quality of Daily life Cognition; Mood;
Trial Locations
- Locations (1)
Beijing Institute of Geriatrics, Xuanwu Hospital
🇨🇳Beijing, China