Clinical Trials

A Phase II clinical trial is evaluating the therapeutic potential of an oral combination of micronized palmitoylethanolamide and polydatin in patients with irritable bowel syndrome. Sponsored by CM&D Pharma Limited in collaboration with Maria Cristina Comelli, this study was designed to assess clinical parameters and symptom reduction, though its recruitment status remains unknown. Consequently, clinical research on polydatin remains in its early stages, primarily focusing on functional gastrointestinal conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01370720 Unknown status
Irritable Bowel Syndrome
MARIA CRISTINA COMELLI|CM&D Pharma Limited
 2010-02 Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Polydatin downregulates lipopolysaccharide-induced intracellular adhesion molecule-1 expression and suppresses platelet aggregation, thereby attenuating leukocyte-endothelial cell adhesion and microvascular dysfunction. This inhibition of inflammatory cell interactions and microcirculatory damage provides a rationale for managing mucosal inflammation and symptoms in irritable bowel syndrome.

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>).

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Note: Technical data last updated: Sep 1, 2026.