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Sponsors and Collaborators: |
Xuanwu Hospital, Beijing Ministry of Health, China Michael J. Fox Foundation for Parkinson's Research |
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Information provided by: | Xuanwu Hospital, Beijing |
ClinicalTrials.gov Identifier: | NCT00461942 |
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
Condition | Intervention | Phase |
---|---|---|
Parkinson's Disease |
Drug: Green Tea Polyphenols (EGCG/ECG) |
Phase II |
Study Type: | Interventional |
Study Design: | Crossover Assignment, Double-Blind, Placebo Control, Randomized, Safety/Efficacy Study, Treatment |
Official Title: | 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 |
Estimated Enrollment: | 480 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | October 2008 |
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.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Zhaohui Qin, MD | 8+86-10-83161294 |
China | |
Beijing Institute of Geriatrics, Xuanwu Hospital | Recruiting |
Beijing, China, 100053 | |
Contact: Zhaohui Qin, MD +86-10-83161294 | |
Principal Investigator: Piu Chan, MD PhD |
Principal Investigator: | Piu Chan, MD, PhD | Xuanwu Hospital, Beijing |
Study ID Numbers: | 2004BA702B02-2 |
Study First Received: | April 17, 2007 |
Last Updated: | April 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00461942 History of Changes |
Health Authority: | China: State Food and Drug Administration |
Green Tea; Health Food; Neuroprotection |
Signs and Symptoms Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Movement Disorders Parkinson Disease Nervous System Diseases Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |