Ginsenoside Rd Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

Multiple clinical trials sponsored by Xijing Hospital have evaluated the efficacy and safety profile of Ginsenoside Rd as a potential neuroprotective treatment for acute ischemic stroke. The clinical program progressed from a randomized, double-blind, placebo-controlled Phase II trial to a pivotal multicenter Phase III trial, with all studies achieving completed recruitment status. These completed investigations demonstrate the dedicated clinical evaluation of Ginsenoside Rd for patients experiencing acute ischemic stroke.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00815763	COMPLETED	Ischemic Stroke	Xijing Hospital	2006-09	PHASE3
NCT00591084	COMPLETED	Ischemic Stroke	Xijing Hospital	2005-09	PHASE2

(data from https://clinicaltrials.gov, updated on 2008-12-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ginsenoside Rd inhibits TNF-alpha-induced NF-kB transcriptional activity and blocks intracellular calcium influx, thereby suppressing the expression of inflammatory mediators COX-2 and iNOS. By preventing calcium overload and downregulating pro-inflammatory signaling cascades, the compound attenuates neuronal cellular damage, supporting its therapeutic application in acute ischemic stroke.

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>).