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Efficacy of Ethnodyne Visio in Parkinson's Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02815800
Acronym
ETHNOPARK
Enrollment
24
Registered
2016-06-28
Start date
2016-09-02
Completion date
2018-03-12
Last updated
2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Treatment, Motor signs, Non motor signs, Fluctuations, Open labelled

Brief summary

ETHNODYNE VISIO is a food supplement composed of an innovative plant-based active ingredient acting alongside vitamin B2. It is proposed in patients with visual problems. Based on clinical and experimental data, the investigators propose a pilot open study in order to test the efficacy of Ethnodyne visio in patients with Parkinson 's disease (PD). The hypothesis is that Ethnodyne visio may improve motor and non motor signs of PD. 24 patients with PD will be evaluated before and after 3 months of add on treatment by Ethnodyne visio.

Interventions

DIETARY_SUPPLEMENTETHNODYNE VISIO

Sponsors

ETHNODYNE
CollaboratorUNKNOWN
University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients with Parkinson disease (PD) with at least 3 years of evolution * Hoehn and Yahr score 2 or 3 * with moderate fluctuations (score 1 or 2 for item 3 score IV MSD UPDRS) * with no modification in anti-parkinsonian drugs since at least 1 month * minimental test \>24

Exclusion criteria

* known intolerance to Ethnodyne visio * woman of childbearing potential or breastfeeding * anticipated anti-parkinsonian treatment modification during the 3 months of the study * antidepressant or anxiolytic drugs modified within one month prior to inclusion visit * other chronic disease * concomitant participation in a another clinical trial * Subject under legal guardianship

Design outcomes

Primary

MeasureTime frame
Change in MDS UPDRS III scorebaseline and following 3 months of treatment

Secondary

MeasureTime frame
Change in MDS UPDRS I, II and IV scorebaseline and following 3 months of treatment
Change in Levodopa equivalent dose treatment (equivalence table)baseline and following 3 months of treatment
Frequency, seriousness and severity of adverse event reactionsduring the 3 months of treatment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026