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Clinical Trial Summary

The aim of this study is to assess the efficacy and efficiency of a nutraceutical from sea urchin eggs with Echinochrome A in the inflammation of tissues in subjects with long Corona Virus (COVID) syndome


Clinical Trial Description

This is a double-blind placebo-controlled study in approximately 60 subjects with long COVID syndrome. After being informed about the study and potential risks, all subjects giving written informed consent will be screened to assess initial respiratory, cardiological inflammatory, neurological and emotional conditions. Prior to the first administration of the treatment, subjetcs will be randomized to receive three vials of the Dietary Supplement with sea urchin eggs extract with presence of the antioxidant Echinochrome A or placebo. According with the ACRO suggestions this study is focus on the patients. Subjects will be monitor by a Telemedicine platform called SkyMed developed for this study to assess their health daily and will have a weekly virtual meeting with a counselors to assess emotional state. Subjects will attend tp the Hospital, at the beggining of the study, and after finishing the vials of the Dietary Supplement (30, 60 and 90 days). Clinical, cardiological, neumonological and neurological studies will carried out to asses the systemic health as well as the quality of life indicators. Inflammation, trombolotic and inmune indicators will be assess in blood samples (basal, 30, 60 and 90 days). The main objetivec behind this clinical trial is to diminish ROS in the cells, enhance gluthation pathways and diminish cellular inflammation. Echinochrome A is a powerfull marine poliphenol with known antioxidant activity found in the eggs, shells and spines of sea urchins, that had been use in eastern medicien for a long time. Powder of sea urchin eggs are mention in Materia Medica back far 1647 as a powerfull anti inflamation agent. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05531019
Study type Interventional
Source Hospital Donación Francisco Santojanni
Contact
Status Completed
Phase N/A
Start date September 22, 2021
Completion date December 18, 2022

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