An interventional study of ViNeuro in Parkinson Disease, sponsored by Hospital Authority, Hong Kong. Completed at 5 sites in China. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2013-09-05.
Sponsored by Hospital Authority, Hong Kong · Not applicable, Interventional, and Treatment
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 160 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Hospital Authority, Hong Kong is the lead sponsor of 73 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
A subject will be eligible for study participation if he/she meets all the following criteria:
Exclusion Criteria:
A subject will be excluded from the study if he/she meets any of the following criteria:
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
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Hospital Authority, Hong Kong