Using Glialia for Treating Persistent Perceptual Postural Dizziness

Last updated: December 16, 2024
Sponsor: I.R.C.C.S. Fondazione Santa Lucia
Overall Status: Active - Recruiting

Phase

4

Condition

Low Blood Pressure (Hypotension)

Dizzy/fainting Spells

Treatment

Placebo

Control

Glialia

Clinical Study ID

NCT06741358
N.153/SL/24
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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.

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 4
Study Start date:
October 11, 2024
Estimated Completion Date:
October 10, 2026

Connect with a study center

  • Fondazione Santa Lucia IRCCS

    Rome, RM 00142
    Italy

    Active - Recruiting

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