The investigational product is a specially formulated TCM and administered in the form of a capsule. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
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
The primary efficacy outcome is the change from baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) (Appendix 6) Parts II and III total scores at the end of 24 weeks. The UPDRS is to be performed one hour after L-dopa treatment.
Time frame: 24 Weeks
Change from baseline in the individual Part II and Part III total scores, sum of Parts I-III total scores, Part IV total score of the UPDRS at each follow-up visit...
Time frame: 24 weeks
Change from baseline in the number of "off" hours throughout the study at each follow-up visit.
Time frame: The mean number of daily "off" hours over the last 7 days before each study visit, except for the screening visit, will be used for the analysis.
Change from baseline in the total daily dose in patients who received concomitant levodopa therapy throughout the study at each follow-up visit; Change from baseline in Red Cell Superoxide Dismutase Activity at 24 week.
Time frame: 24 weeks
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