Dioscin Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

A completed clinical trial sponsored by North Carolina Agricultural and Technical State University evaluated the natural saponin compound dioscin, focusing on dietary saponin bioavailability, human health, polyphenols, and pharmacokinetics. Because the study assessed nutrient absorption and metabolic profiling rather than direct therapeutic dosing, its formal trial phase was classified as Not Applicable. Overall, clinical evaluation of dioscin remains in an exploratory stage centered on human exposure and pharmacokinetic characterization.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04335435	Completed	Human Health\|Polyphenols\|Pharmacokinetics	North Carolina Agriculture & Technical State University	2016-01-15	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dioscin activates the mitochondrial apoptotic pathway by stimulating caspase-9 and caspase-3 cleavage, which directly suppresses cell viability and executes programmed cell death in tumor models. This pro-apoptotic mechanism and its associated cellular effects provide the biological rationale for evaluating dioscin in human health studies focused on polyphenol and saponin pharmacokinetics.

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>).