Efficacy of Ethnodyne Visio in Parkinson's Disease

Parkinson's Disease Clinical Trial

— ETHNOPARK  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02815800
• Other study ID #: 6312
• Status: Completed
• Phase: N/A
• First received: June 13, 2016
• Last updated: April 16, 2018
• Start date: September 2, 2016
• Est. completion date: March 12, 2018

Study information

• Verified date: April 2018
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 12, 2018
• Est. primary completion date: March 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Dietary Supplement:
• ETHNODYNE VISIO

Locations

Country	Name	City	State
France	Service de Neurologie,Hôpital de Hautepierre	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France	ETHNODYNE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in MDS UPDRS III score		baseline and following 3 months of treatment
Secondary	Change in MDS UPDRS I, II and IV score		baseline and following 3 months of treatment
Secondary	Change in Levodopa equivalent dose treatment (equivalence table)		baseline and following 3 months of treatment
Secondary	Frequency, seriousness and severity of adverse event reactions		during the 3 months of treatment