Cortex Acanthopanacis Senticosus Extract Clinical Trials

Size	Price	Qty
5mg	USD 89

Clinical Trials

Multiple clinical trials are currently evaluating applications within this compound's investigational scope, though all are categorized as not yet recruiting. A clinical trial sponsored by military health institutions prospectively assesses myocarditis following replication-deficient smallpox vaccination in an unassigned phase setting. Additionally, an Early Phase 1 trial sponsored by the University of Alabama at Birmingham focuses on evaluating metabolic and functional abnormalities in primary mitral valve regurgitation using advanced cardiac imaging.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05513313	Not yet recruiting	Myopericarditis\|Small Pox	Womack Army Medical Center\|United States Naval Medical Center San Diego\|C.R.Darnall Army Medical Center	2029-03	--
NCT04795856	Not yet recruiting	Mitral Valve Regurgitation	University of Alabama at Birmingham	2027-06-18	Early Phase 1

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

Check the Cortex Acanthopanacis Senticosus Extract product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cortex Acanthopanacis Senticosus Extract contains bioactive phytochemicals that suppress pro-inflammatory cytokine production and scavenge intracellular reactive oxygen species. This inhibition mitigates downstream cellular oxidative stress and aberrant proliferation, providing a biochemical rationale for investigating its therapeutic relevance in cardiovascular and inflammatory conditions such as myopericarditis and primary mitral valve regurgitation.

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>).