Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06741358

Use of the Glialia Supplement in the Treatment of Persistent Perceptual Postural Imbalance A Triple-Blind, Randomized, Placebo-Controlled Pilot Clinical Trial

Led by I.R.C.C.S. Fondazione Santa Lucia · Updated on 2025-11-20

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of the Glialia supplement in people diagnosed with Persistent Perceptual Postural Dizziness (PPPD). This pilot study involves 30 participants, including 20 PPPD patients who may or may not have had a previous COVID-19 infection, and 10 control participants who have recovered from COVID-19. The main goal is to compare neuroinflammation levels between PPPD patients and controls and to see if Glialia reduces neuroinflammation more than a placebo. The trial is triple-blind, meaning neither participants nor researchers know who receives which treatment. Participants are randomly assigned to one of three groups: PPPD patients receiving Glialia, PPPD patients receiving a placebo that looks identical to Glialia, and control participants who have recovered from COVID-19 and receive Glialia. All participants take two soluble sachets daily for 60 days. The Glialia supplement contains 700 mg of Palmitoylethanolamide (umPEA) with supportive ingredients. The placebo group receives a matching treatment without active ingredients. During the study, participants will be assessed at the start and after 60 days for neuroinflammation levels. Additional evaluations include gait quality, dizziness impact, brain fog, and personality traits. Researchers will monitor mental clarity, quality of life, balance, and neuroinflammation changes. The study provides all treatments at no cost and includes safety and outcome monitoring throughout the 60-day treatment period.

CONDITIONS

Brief Title

Using Glialia for Treating Persistent Perceptual Postural Dizziness

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Diagnosis of Persistent Perceptual Postural Dizziness (PPPD) for PPPD groups
  • Recovery from COVID-19 infection or no previous COVID-19 infection for PPPD groups
  • Previous COVID-19 infection for the control group, matched for timing to PPPD-Glialia group
Not Eligible

You will not qualify if you...

  • Concurrent neurological and otological disorders other than PPPD for PPPD groups
  • Neurological and otological disorders for control group
  • Pregnant women in all groups

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 60 days

Participants take two soluble sachets daily of either the Glialia supplement or placebo for 60 days to evaluate effects on neuroinflammation, mental clarity, quality of life, balance, and gait quality.

1 baseline visit and 1 follow-up visit

Trial Site Locations

Total: 1 location

1

Fondazione Santa Lucia IRCCS

Rome, RM, Italy, 00142

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Research Team

I

Iole Indovina, PhD

D

Diego Piatti, PT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Abnormal Vestibulo-Ocular Reflex Function Correlates with Balance and Gait Impairment in People with Multiple Sclerosis.

Marco Tramontano, Laura Casagrande Conti, Amaranta Soledad Orejel Bustos...

https://pubmed.ncbi.nlm.nih.gov/39311220

Validity and reliability of the Niigata PPPD Questionnaire in a Western population.

Rodrigo Castillejos-Carrasco-Muñoz, Ana Belén Peinado-Rubia, Miguel Ángel Lérida-Ortega...

https://pubmed.ncbi.nlm.nih.gov/37266755

Personality traits modulate subcortical and cortical vestibular and anxiety responses to sound-evoked otolithic receptor stimulation.

Iole Indovina, Roberta Riccelli, Jeffrey P Staab...

https://pubmed.ncbi.nlm.nih.gov/25262497