A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease
NCT ID: NCT00517842
Last Updated: 2013-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2005-10-31
2008-09-30
Brief Summary
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Basic pre-clinical studies have suggested that it may have good immunomodulating functions, increases the activities of T-cells, B-cells and NK cells, enhances mitochondrial antioxidant status on various tissues including brain tissues. Therefore, this formulation may have special values in improving symptoms in Parkinson's disease patients.
The purpose of the study is to determine the efficacy and safety of ViNeuro in patients with Parkinson's disease.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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ViNeuro
Eligibility Criteria
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Inclusion Criteria
1. Age of at least 30 years
2. Diagnosis of symptomatic, idiopathic Parkinson' disease using The United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria (Appendix 3 in the protocol)
3. Stage 1-4 on the modified Hoehn and Yahr scale (Appendix 4 in the protocol)
4. Possesses three of the four cardinal signs of Parkinson's disease, i.e. rigidity, bradykinesia, resting tremor and postural instability, without any other known or suspected cause for their parkinsonism
5. If receiving levodopa or other symptomatic treatments, the subject should have shown a good response to it and have been on a stable dosage for at least 1 month prior to study entry
6. Voluntarily signs and dates an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures.
Exclusion Criteria
1. Presence of atypical parkinsonian syndromes
2. Dementia as defined by the Mini-Mental State Examination score (Appendix 5 in the protocol) of 22 or less
3. Serious concurrent illness, such as active cardiac, renal, liver, or neoplastic disease
4. Used centrally active therapies, e.g. hypnotics, antidepressants, anxiolytics, within 60 days before study entry
5. Used methylphenidate, cinnarizine, reserpine, amphetamine, or monoamine oxidase-A inhibitors, e.g. pargyline, phenelzine, or tranylcpromine, within 3 months of study entry
6. Has history of receiving any neuroleptics
7. Used alpha-methyldopa or flunarizine within 6 months of study entry
8. Females who are pregnant or breastfeeding.
9. Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study (Visit 1).
10. Subjects who are taking any traditional Chinese medication, or has been taking any traditional Chinese medication within the last 2 weeks prior to screening of this study (Visit 1).
11. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
30 Years
ALL
No
Sponsors
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Vigconic (International) Ltd.
INDUSTRY
Hospital Authority, Hong Kong
OTHER_GOV
Principal Investigators
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Jonas HM Yeung, Dr
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine and Therapeutics, Prince of Wales Hospital/ The Chinese University of Hong Kong
Locations
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Prince of Wales Hospital
Hong Kong, , China
Princess Margaret Hospital
Hong Kong, , China
Queen Elizabeth Hospital
Hong Kong, , China
Tseung Kwan O Hospital
Hong Kong, , China
United Christian Hospital
Hong Kong, , China
Countries
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Other Identifiers
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HARECCTR0500017
Identifier Type: -
Identifier Source: secondary_id
CRE-2005-228-T
Identifier Type: -
Identifier Source: org_study_id