Polydatin Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials evaluate the therapeutic potential of polydatin across conditions including pediatric and adult irritable bowel syndrome, hemorrhagic, traumatic, and septic shock, and endometriosis associated with chronic pelvic pain. Sponsored by academic and corporate entities, these Phase 2 evaluations feature recruitment statuses ranging from completed to unknown. Overall, these studies underscore ongoing clinical interest in polydatin's anti-inflammatory and cytoprotective properties.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05867693	UNKNOWN	Irritable Bowel Syndrome	University of Roma La Sapienza	2023-04-19
NCT02372903	COMPLETED	Endometriosis; Chronic Pelvic Pain	University of Cagliari	2013-10
NCT01780129	UNKNOWN	Shock, Hemorrhagic; Shock, Traumatic; Shock, Septic	Neptunus Pharmaceuticals Inc.	2013-02	PHASE2
NCT01370720	UNKNOWN	Irritable Bowel Syndrome	MARIA CRISTINA COMELLI	2010-02	PHASE2

(data from https://clinicaltrials.gov, updated on 2023-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a stilbenoid polyphenol glucoside, polydatin modulates key pro-inflammatory mediators and activates cellular antioxidant pathways, thereby suppressing oxidative stress cascades and mitigating inflammatory cellular damage. This dual suppression of inflammatory signaling and oxidative tissue injury provides a biochemical rationale for its therapeutic evaluation in conditions characterized by severe tissue inflammation and vascular compromise, including irritable bowel syndrome, septic shock, and endometriosis-associated pelvic pain.

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>).