Perillaldehyde Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Several clinical trials are currently registered to evaluate interventions across diverse conditions, including chronic pain, type 1 diabetes, prediabetes, surgical amputation, and paroxysmal atrial fibrillation. Reflecting non-pharmacological, observational, or device-focused protocols, these studies are designated exclusively as phase "Not Applicable" or unclassified. Sponsored by academic and regional entities—including Bridgewater College, the University of Minnesota, Children's Mercy Hospital Kansas City, and the VA Office of Research and Development—all of these trials share an active status of not yet recruiting participants.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06077526	Not yet recruiting	Chronic Pain	Bridgewater College	2026-01-13	Not Applicable
NCT06018844	Not yet recruiting	Type 1 Diabetes	Children''s Mercy Hospital Kansas City\|University of Kansas\|Nemours Children''s Clinic	2025-04	--
NCT06365723	Not yet recruiting	PreDiabetes	University of Minnesota	2025-01-15	Not Applicable
NCT05990062	Not yet recruiting	Amputation Surgical	VA Office of Research and Development\|Stumpworx LLC	2024-10-01	Not Applicable
NCT04600713	Not yet recruiting	Atrial Fibrillation Paroxysmal	Vastra Gotaland Region	2024-10	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Perillaldehyde suppresses benzo[a]pyrene-induced aryl hydrocarbon receptor (AHR) activation while activating the NRF2/HO-1 antioxidant pathway, thereby reducing reactive oxygen species generation and blocking pro-inflammatory CCL2 chemokine release. This dual modulation of oxidative stress and inflammatory signaling provides a biochemical basis for mitigating tissue damage in chronic inflammatory and metabolic conditions evaluated in clinical settings.

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>).