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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05311852 |
|
Full text link
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
2022-04-05 |
|
Recruitment status
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
Long covid |
|
Inclusion criteria
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
inclusion criteria: previous diagnosis of sars-cov-2 infection confirmed through detection of virus rna by polymerase chain reaction (pcr) testing of a nasopharyngeal swab; 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
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
prior or concurrent diagnosis of neurological, psychiatric, endocrine, metabolic or cardiopulmonary conditions; 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 |
|
Number of arms
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy |
|
Inclusion age min
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
Italy |
|
Type of patients
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
Patients recovered from covid |
|
Severity scale
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
34 |
|
primary outcome
Last imported at : Sept. 28, 2022, 5:30 a.m. Source : ClinicalTrials.gov |
changes in % of test amplitude in LICI 100 |
|
Notes
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : April 6, 2022, 9 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 1660, "treatment_name": "Luteolin+palmitoylethanolamide", "treatment_type": "Others pharmacological treatment+vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |