Ginseng Extract Clinical Trials

Size	Price	Qty
5mg	USD 90

Clinical Trials

According to clinical registry records, Ginseng Extract has been evaluated in a clinical trial investigating pediatric upper respiratory tract infection. This completed Phase 2 trial examined the safety and potential efficacy of different dosing schedules in pediatric patients. The study was supported by a combination of academic, health authority, and commercial entities, including the University of Alberta, Capital Health Canada, CV Technologies, and Afexa Life Sciences Inc.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00255307	Completed	Upper Respiratory Infection	CV Technologies\|University of Alberta\|Capital Health Canada\|Afexa Life Sciences Inc	2005-11	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ginseng Extract contains active ginsenosides that interact with cell-surface immune receptors and intracellular signaling proteins, thereby downregulating pro-inflammatory cytokine cascades and modulating immune cell activation. This immunomodulatory activity attenuates mucosal inflammatory responses and bolsters host defenses, offering a functional rationale for its clinical study in upper respiratory tract infections.

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>).