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Sponsored by: |
Xuanwu Hospital, Beijing |
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Information provided by: | Xuanwu Hospital, Beijing |
ClinicalTrials.gov Identifier: | NCT00224263 |
The purpose of this study is to determine whether Lingzhi (Ganoderma), a widely used traditional Chinese Medicine is effective and safe in the treatment of Parkinson’s disease when combined use with L-dopa.
Condition | Intervention | Phase |
---|---|---|
Parkinson's Disease |
Drug: Lingzhi (Ganoderma) |
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 Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease Receiving Stable L-Dopa/DCI |
Estimated Enrollment: | 360 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | October 2007 |
This study is to focus on the effects of Lingzhi on non-motor symptoms of Parkinson's diseases as the primary outcome and on delaying the disease progression using the delay start design as the secondary outcome measurement. Two dosage groups and one placebo control group with total 360 subjects will be recruited. The treatment is one year.
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
have idiopathic Parkinson’s disease, defined as:
Exclusion Criteria:
Study ID Numbers: | 2004BA702B02 |
Study First Received: | September 20, 2005 |
Last Updated: | April 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00224263 History of Changes |
Health Authority: | China: Ministry of Health |
Lingzhi Traditional Chinese Medicine |
Signs and Symptoms Levodopa Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Dihydroxyphenylalanine 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 |