Using Glialia to treat Persistent Perceptual Postural Dizziness
Use of the Glialia Supplement in the Treatment of Persistent Perceptual Postural Imbalance: A Triple-Blind, Randomized, Placebo-Controlled Pilot Clinical Trial
This study is testing if a supplement called Glialia can help reduce brain inflammation in people with Persistent Perceptual Postural Dizziness compared to those who receive a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | I.R.C.C.S. Fondazione Santa Lucia Academic / other |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT06741358 on ClinicalTrials.gov |
What this trial studies
This pilot study involves 30 participants, including 20 patients diagnosed with Persistent Perceptual Postural Dizziness (PPPD) and 10 control participants who have recovered from COVID-19. Participants will be randomly assigned to receive either the Glialia supplement or a placebo, with the aim of comparing neuroinflammation levels between the groups. The study will be conducted in a triple-blind manner to ensure unbiased results, and it seeks to determine if Glialia can significantly reduce neuroinflammation in PPPD patients compared to the placebo group. The outcomes will help assess the influence of previous COVID-19 infection on neuroinflammation levels.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 65 diagnosed with Persistent Perceptual Postural Dizziness, regardless of previous COVID-19 infection.
Not a fit: Patients with concurrent neurological or otological disorders, or those who are pregnant, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from Persistent Perceptual Postural Dizziness.
How similar studies have performed: While this approach is novel in the context of PPPD, similar studies targeting neuroinflammation have shown promise in other conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome, RM
- Fondazione Santa Lucia IRCCS — Rome, Rm, Italy (Recruiting)
Study contacts
- Principal investigator: Iole Indovina, PhD — Department of Systems Medicine, University of Rome Tor Vergata Rome, Italy ; Centre of Space Bio-medicine, University of Rome Tor Vergata Rome, Italy ; Laboratory of Neuromotor Physiology, IRCCS Santa Lucia Foundation Rome, Italy.
- Study coordinator: Iole Indovina, PhD
- Email: i.indovina@hsantalucia.it
- Phone: 0039 0651501476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.