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CompletedNCT00517842Updated Sep 5, 2013

A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease

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

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Parkinson Disease

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Keywords

  • Parkinson's disease
03

In context

Parkinson 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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All

Inclusion criteria

  • A subject will be eligible for study participation if he/she meets all the following 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

Exclusion Criteria:

  • A subject will be excluded from the study if he/she meets any of the following 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
160 participants (estimated)

Interventions

  • DrugViNeuro
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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

07

Study locations

5 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00517842
Lead sponsor
Hospital Authority, Hong Kong
Collaborators
Vigconic (International) Ltd.
First posted
Aug 17, 2007
Start date
Oct 2005
Completion
Sep 2008
Last update
Sep 5, 2013

Study contacts

Jonas HM Yeung, Dr
principal investigator · Department of Medicine and Therapeutics, Prince of Wales Hospital/ The Chinese University of Hong Kong
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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