Multiple clinical trials evaluate physiological and health parameters across conditions including oxidative stress, long COVID, bone loss, energy deficiency, and psychiatric disorders. Sponsored by academic institutions, university hospitals, and national research councils—such as the University of Thessaly, Brock University, and the University of Barcelona—these unphased protocols encompass completed, active not recruiting, enrolling by invitation, and withdrawn statuses. Specific investigations evaluate dietary and antioxidant interventions targeting blood redox status, as well as physical exercise programs for managing long COVID symptoms.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04380155 | Withdrawn | Bone Loss|Energy Supply; Deficiency |
Brock University|Natural Sciences and Engineering Research Council Canada |
2023-09-20 | Not Applicable |
| NCT05848518 | Completed | Long COVID |
Campus docent Sant Joan de Déu-Universitat de Barcelona|Hospital de Mataró|University of Barcelona |
2023-05-15 | Not Applicable |
| NCT05756842 | Active not recruiting | Oxidative Stress |
University of Thessaly |
2023-03-06 | Not Applicable |
| NCT05861544 | Enrolling by invitation | Psychiatry |
Organization Against Drugs (ΟΚΑΝΑ)|University of Thessaly |
2023-03-23 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).