Clinical Trials

Multiple clinical trials sponsored by academic and medical institutions—including Tongji Hospital, Milton S. Hershey Medical Center, and Dr. Dean Reeves Clinic—evaluate protocatechuic acid for immune function, anesthesia monitoring, pediatric post-anesthesia recovery, and prosthetic joint infections. These investigations explore dietary supplementation and clinical applications, though currently lack formal phase designations. Additionally, all recorded trials maintain statuses restricted to either not yet recruiting or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06591741 NOT_YET_RECRUITING
Prosthetic Joint Infection
Dr. Dean Reeves Clinic
 2027-01
NCT06591728 NOT_YET_RECRUITING
Prosthesis-Related Infections
Dr. Dean Reeves Clinic
 2025-03-01
NCT06121362 WITHDRAWN
Immunity
Milton S. Hershey Medical Center
 2024-03
NCT06396000 Not yet recruiting
Anesthesia; Adverse Effect
Saiqiang Guo|Tongji Hospital
 2024-05-31 --

(data from https://clinicaltrials.gov, updated on 2026-08-26)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Protocatechuic acid functions as a phenolic antioxidant and anti-inflammatory agent that scavenges reactive oxygen species and downregulates pro-inflammatory nuclear factor kappa B signaling pathways, thereby mitigating cellular oxidative stress and inflammatory damage. This inhibition of oxidative and inflammatory cascades provides the biological rationale for investigating protocatechuic acid as a therapeutic intervention in prosthetic joint infections and immune system modulation.

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>).

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