Effects of PEA-LUT on Frontal Lobe Functions and GABAergic Transmission in Long-Covid Patients
NCT ID: NCT05311852
Last Updated: 2022-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2021-08-16
2022-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PEA-LUT
patients were required to assume granulated PEA-LUT 700/70 mg, 2 time/day for 8 weeks
palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT)
assumption of the product at dosage of 700/70 mg 2 time/day for 8 weeks
Placebo
patients were required to assume granulated placebo, 2 time/day for 8 weeks
Placebo
assumption of a placebo product 2 time/day for 8 weeks
Interventions
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palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT)
assumption of the product at dosage of 700/70 mg 2 time/day for 8 weeks
Placebo
assumption of a placebo product 2 time/day for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* subsequent recovery from infection as defined by two consecutive negative PCR tests separated by at least a day;
* mild form of COVID-19 (symptoms may include fever, cough, sore throat, malaise, myalgia, anorexia, nausea, diarrhoea, anosmia and ageusia) without necessitating hospital admission;
* complaints of cognitive difficulties and/or sense of fatigue, persisting after SARS-CoV-2 infection.
Exclusion Criteria
* clinical and/or radiological evidence of COVID-19 related pneumonia during the active phase of the disease;
* anaemia;
* current pharmacological treatment with corticosteroids, antihistamines, antihypertensives, diuretics, antidepressants, anxiolytic or hypnotic drugs at the time of study
18 Years
ALL
Yes
Sponsors
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I.R.C.C.S. Fondazione Santa Lucia
OTHER
Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy
NETWORK
Responsible Party
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Paola Ortelli
PsyD, Principal Investigator
Principal Investigators
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Leopold Saltuari, Md
Role: STUDY_DIRECTOR
Department of Neurorehabiliation - Hospital of Vipiteno-Sterzing
Locations
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Hospital of Vipiteno-Sterzing
Sterzing, BZ, Italy
Countries
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Other Identifiers
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PEA-LUT-in-Post-Covid-19
Identifier Type: -
Identifier Source: org_study_id
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