Baicalin Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

A clinical trial sponsored by Thomas Jefferson University, an academic institution, evaluated the physiological effects of baicalin-based nutritional support in patients with Parkinson's disease and idiopathic Parkinson's disease. Categorized as phase N/A, this completed study assessed physiological outcomes to determine the therapeutic potential of baicalin in this progressive neurodegenerative disorder. Overall, this completed research represents the registered clinical evaluation of baicalin in human subjects.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02445651	COMPLETED	Parkinson Disease; Idiopathic Parkinson Disease	Thomas Jefferson University	2014-03

(data from https://clinicaltrials.gov, updated on 2025-12-15)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Baicalin functions as an inhibitor of prolyl oligopeptidase and an allosteric activator of carnitine palmitoyltransferase 1 (CPT1), thereby suppressing nuclear factor kappa B (NF-κB) expression and modulating GABA receptor signaling to attenuate neuroinflammatory cascades. This reduction in neuroinflammation and metabolic dysregulation provides a therapeutic rationale for evaluating baicalin in clinical studies targeting Parkinson's disease.

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>).