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Recruiting NCT06741358

Using Glialia for Treating Persistent Perceptual Postural Dizziness

Conditions: Persistent Postural Perceptual Dizziness

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 30
Sponsor: I.R.C.C.S. Fondazione Santa Lucia

Location: Fondazione Santa Lucia IRCCS Rome RM

Summary

This pilot study will involve 30 participants recruited from the Santa Lucia Foundation IRCCS, including 20 patients diagnosed with Persistent Perceptual Postural Dizziness (PPPD), and might or might not have previously contracted Sars Cov2 infection. They who will be randomly assigned to receive either the Glialia supplement or placebo. Additionally, 10 control participants who have recovered from COVID-19 will receive Glialia to help assess the influence of previous COVID-19 infection on neuroinflammation levels. The study aims to compare baseline neuroinflammation levels between PPPD patients and controls, measure changes in neuroinflammation in all groups after treatment and to determine if the reduction in neuroinflammation is more significant in the Glialia group compared to the placebo group. The trial will be conducted in a triple-blind manner, ensuring that neither participants nor researchers know the treatment assignments. Each participant will receive sachets to be taken daily for 60 days, with the study providing both the Glialia supplement and placebo at no cost.

Eligibility Criteria

Inclusion criteria for all groups: -Age between 18 and 65 years. Inclusion criteria for the PPPD-glialia group: * Diagnosis of PPPD; * Recovery from COVID-19 infection or absence of previous infection. Inclusion criteria for the PPPD-placebo group: * Diagnosis of PPPD; * Recovery from COVID-19 infection or absence of previous infection (matched to the PPPD-glialia group). Exclusion criteria for all PPPD-group: * Presence of concurrent neurological and otological disorders other than PPPD; * Pregnant women. Inclusion criteria for the control group: -Previous COVID-19 infection (matched for timing to the PPPD-glialia group). Exclusion criteria for the control group: * Presence of neurological and otological disorders; * Pregnant women.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06741358). StuddyBuddy aggregates publicly available trial information.