Tea polyphenol Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Academic institutions have sponsored multiple clinical trials evaluating green tea extract for precancerous mucosal lesions and treatment-induced tissue inflammation. These efforts included a Phase II trial assessing efficacy in oral leukoplakia and a pilot study investigating preventative potential against therapy-induced mucositis, though all were ultimately terminated. Overall, these studies reflect interest in the localized therapeutic potential of tea polyphenols for mucosal protection and oral oncology.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00176566	Terminated	Oral Leukoplakia	University of Medicine and Dentistry of New Jersey\|Rutgers The State University of New Jersey	2003-09	Phase 2
NCT00176514	Terminated	Mucositis	University of Medicine and Dentistry of New Jersey\|Rutgers The State University of New Jersey	2000-07	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tea polyphenols act as natural antioxidants and anti-carcinogenic agents by scavenging reactive oxygen species and inhibiting key pro-inflammatory cellular signaling cascades. This molecular neutralization reduces oxidative cellular damage and downregulates inflammatory mediators, which is clinically relevant for managing mucosal inflammation and precancerous oral leukoplakia conditions studied in human trials.

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>).