Clinical Trials

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of Barcelona—these unphased protocols encompass completed, active not recruiting, enrolling by invitation, and withdrawn statuses.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NCT04380155 Withdrawn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)

Check the Thiobarbituric acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Thiobarbituric acid selectively reacts with malondialdehyde, a primary biomarker of lipid peroxidation, forming a stable chromogenic adduct that quantifies cellular membrane degradation and oxidative damage. By facilitating the colorimetric detection of lipid peroxidation in biological systems, this assay serves as a critical indicator for evaluating systemic redox balance across trial conditions such as oxidative stress, long COVID, and psychiatric disorders.

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>).

Note: Technical data last updated: Sep 1, 2026.