Pain, Acute Clinical Trial
Official title:
Valutazione Dell'Efficacia e Della Sicurezza Dei Nutraceutici Utilizzati Nella Popolazione Generale Per il Trattamento di Patologie Sistemiche o Locali
Supplements and functional foods are now readily available and usable by the general population. Many supplemnets are commonly used in poly-treated patients where interactions or adverse events may develop, therefore we evaluate in the rela life the use of nutraceuticals, their clinical effects and the development of adverse drug reactions
Status | Recruiting |
Enrollment | 80 |
Est. completion date | November 29, 2023 |
Est. primary completion date | November 29, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility | Inclusion Criteria: - Patients or healthy subjects of both sexes and aged> 18 years Patients are not on supplement therapy or functional foods for any purpose. - Patients who have given their consent to participate in the study Exclusion Criteria: - Patients with severe renal or liver failure, neoplastic diseases or those with allergy to supplement or functional food , and those who do not sign the consent will be excluded from the study. Informed. |
Country | Name | City | State |
---|---|---|---|
Italy | Luca Gallelli | Catanzaro |
Lead Sponsor | Collaborator |
---|---|
University of Catanzaro | Annunziata Hospital, Cosenza, Italy, Azienda Ospedaliera Pugliese Ciaccio, Azienda Ospedaliera Universitaria Policlinico, Azienda Sanitaria Provinciale Di Catanzaro |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | improvement of memory | Mini-mental state examination: range from 0 (worst) to 30 (no deficit) (< 18 severe deficit, 19-24 mild deficit, >25 normal function) | 6 months | |
Primary | improvement of pain | Visual analogical scale: range from 0 (no pain) to 10 (high pain) > 8 severe pain; 4-7 moderate pain; 1-3 mild pain) | 6 months | |
Secondary | change in plasma lipid values | LDL (mg/dL), HDL (mg/dL), total cholesterol (mg/dL) | 12 months | |
Secondary | improvement of quality of life | 36-Item Short Form Health Survey (SF-36), range from 0 (worst) to 100 (best) | 6 months |
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