NCT00461942CompletedPhase 2
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 480
- Locations
- 2
- Primary Endpoint
- Delay of progression of Motor dysfunction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Delay of progression of Motor dysfunction
Secondary Outcomes
- Quality of Daily life
- Mood;
- Cognition;
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Effects of Green Tea Extracts on Gastric Mucosal ProtectionFunctional DyspepsiaNCT04742985Pusan National University Yangsan Hospital24
Completed
Phase 2
Effect of Green Tea (Epigallocatechin Gallate) on Albuminuria in Patients With Diabetic Nephropathy.HypertensionDiabetic NephropathyNCT01923597University of Campinas, Brazil50
Completed
Phase 1
Defined Green Tea Catechin Extract in Preventing Esophageal Cancer in Patients With Barrett's EsophagusBarrett EsophagusNCT00233935National Cancer Institute (NCI)55
Completed
Not Applicable
Intervention Effect of TP and AOB-w on Acrylamide Exposure in Chinese AdolescentsInterventionNCT03118167Zhejiang University110
Terminated
Not Applicable
A Pilot Trial to Assess the Effects of Green Tea in the Prevention of Therapy-Induced MucositisMucositisNCT00176514University of Medicine and Dentistry of New Jersey37