Efficacy of Ethnodyne Visio in Parkinson's Disease (ETHNOPARK)

University Hospital, Strasbourg, France

Status: Completed

Conditions: Parkinson's Disease

Treatments: Dietary Supplement: ETHNODYNE VISIO

Study type: Interventional

Funder types: Other

Identifiers

NCT02815800

6312

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

ETHNODYNE VISIO

Experimental group

Description:

Administration 2 times a day of a dietary supplement, as add on therapy, in patients with Parkinson s disease

Treatment:

Dietary Supplement: ETHNODYNE VISIO