Green tea Extract Clinical Trials

Size	Price	Qty
5mg	USD 89

Clinical Trials

Multiple completed clinical trials have evaluated Green Tea Extract across oncology and infectious disease, targeting conditions such as colorectal neoplasms, chronic hepatitis C, and oxidative stress. Sponsored by academic and governmental entities—including Seoul National University Hospital, the University of North Carolina Chapel Hill, and the National Institutes of Health—these investigations encompass unphased and Phase 1 studies. Overall, this research assesses the extract's preventive efficacy against adenoma and colorectal cancer alongside its steady-state pharmacokinetic interactions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02321969	Completed	Neoplasms Colorectal	Seoul National University Hospital	2010-08	Not Applicable
NCT01018615	Completed	Chronic Hepatitis C\|Oxidative Stress	University of North Carolina Chapel Hill\|National Center for Complementary and Integrative Health (NCCIH)\|National Institutes of Health (NIH)	2009-11	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Green Tea Extract contains bioactive catechins that scavenge reactive oxygen species and modulate key intracellular signaling cascades, thereby attenuating oxidative damage and inhibiting aberrant cellular proliferation. By suppressing oxidative stress and cell proliferation, this extract demonstrates therapeutic relevance across clinical trials evaluating colorectal neoplasms and chronic hepatitis C infection.

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>).