Parkinson's DiseasePhase 2NCT00461942
Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients
A Phase 2 study testing Green Tea Polyphenols (EGCG/ECG) in people with Parkinson's Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Green Tea Polyphenols (EGCG/ECG)
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- Apr 2006to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Green Tea Polyphenols (EGCG/ECG)
- Keywords
- Health Food;, Green Tea;, Neuroprotection
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green Tea Polyphenols (EGCG/ECG)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay of progression of Motor dysfunction
Secondary outcomes (3)
Cognition;
Mood;
Quality of Daily life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startApr 2006
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, China, Michael J. Fox Foundation for Parkinson's Research
- Investigators
- Piu Chan, MD, PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461942
- Sponsor's protocol ID
- 2004BA702B02-2
- Status last verified
- Aug 2011
- First submitted
- 17 Apr 2007
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00461942
- Acronym / sponsor ID
- 2004BA702B02-2
- Conditions
- Parkinson's Disease
- Keywords
- Health Food;, Green Tea;, Neuroprotection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Ministry of Health, China, Michael J. Fox Foundation for Parkinson's Research
- Study start
- Apr 2006
- Study completion
- Mar 2009 (actual)
- First posted
- 18 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green Tea Polyphenols (EGCG/ECG) | Drug | – |
Primary outcome
Delay of progression of Motor dysfunction
3 secondary outcomes
Cognition;
Mood;
Quality of Daily life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piu Chan, MD, PhD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Green Tea Polyphenols (EGCG/ECG) in people with Parkinson's Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay of progression of Motor dysfunction. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2011.