Ginsenoside Re Clinical Trials

Size	Price	Qty
10mg	USD 107

Clinical Trials

A completed early phase 1 clinical trial sponsored by an academic research center, the Washington University School of Medicine, evaluated the efficacy and physiological impact of Ginsenoside Re in patients with diabetes and impaired glucose tolerance. The investigation aimed to characterize the therapeutic potential of this natural protopanaxatriol saponin within human metabolic regulation. Overall, the clinical landscape for Ginsenoside Re is targeted specifically toward metabolic and glycemic disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00781534	COMPLETED	Diabetes	Washington University School of Medicine	2003-09	EARLY_PHASE1

(data from https://clinicaltrials.gov, updated on 2019-09-09)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ginsenoside Re suppresses c-Jun N-terminal kinase (JNK) and nuclear factor kappa B (NF-κB) signaling pathways, thereby inhibiting downstream pro-inflammatory mediator expression and reducing oxidative stress within metabolic tissues. By attenuating inflammatory signaling and vascular damage, this mechanism enhances cellular insulin sensitivity and glucose homeostasis, providing a rational basis for its application in diabetes.

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>).