Ammonium Glycyrrhizinate Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

A clinical trial evaluated the physiological effects of liquorice derivative consumption, specifically focusing on apparent mineralocorticoid excess and the salivary cortisol to cortisone molar ratio. Sponsored by a healthcare trust, The Royal Wolverhampton Hospitals NHS Trust, the study has reached a completed recruitment status. Its trial phase was designated as Not Applicable, reflecting a physiological evaluation rather than a traditional interventional trial to elucidate the compound's endocrine and metabolic impacts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02939144	Completed	Apparent Mineralocorticoid Excess	The Royal Wolverhampton Hospitals NHS Trust	2016-11	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ammonium Glycyrrhizinate directly binds to high mobility group box 1 (HMGB1) and inhibits 11β-hydroxysteroid dehydrogenase, thereby disrupting downstream pro-inflammatory pathways and hepatic steroid metabolism. This targeted enzyme and protein inhibition reduces cellular inflammatory signaling and impairs systemic cortisol conversion, providing biochemical relevance to clinical investigations of apparent mineralocorticoid excess.

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>).