(+)-Gallocatechin Clinical Trials

Size	Price	Qty
1mg	USD 147

Clinical Trials

Multiple clinical trials evaluate green tea formulations containing catechins across Phase 1 through Phase 3 and unassigned phase classifications. These studies address diverse indications, including metabolic inflammation and endotoxemia in obesity, steroid profiling in healthy volunteers for sports doping control, progression of multiple system atrophy, and diabetic nephropathy with hypertension. Sponsored primarily by academic institutions, research foundations, and anti-doping organizations, these registered trials include completed studies alongside those with unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03413735	Unknown status	Obesity\|Endotoxemia\|Inflammation	Ohio State University	2018-08-29	Not Applicable
NCT02779361	Completed	Healthy Volunteers\|Doping in Sports	Parc de Salut Mar\|World Anti-Doping Agency	2016-01	Phase 1
NCT02008721	Completed	Multiple System Atrophy	Dr. Johannes Levin\|German Center for Neurodegenerative Diseases (DZNE)\|Deutsche Parkinson Vereinigung\|German Foundation for Neurology\|ParkinsonFonds Deutschland gGmbH\|Ludwig-Maximilians - University of Munich	2014-01	Phase 3
NCT01923597	Completed	Diabetic Nephropathy\|Hypertension	University of Campinas Brazil	2013-11	Phase 2

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

Check the (+)-Gallocatechin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

(+)-Gallocatechin selectively binds to human cannabinoid receptors and exerts antioxidant properties, thereby inhibiting downstream reactive oxygen species accumulation and inflammatory signaling pathways. This cellular modulation mitigates oxidative stress and tissue damage, offering potential therapeutic relevance in managing metabolic inflammation, diabetic nephropathy, and neurodegenerative disorders investigated in clinical settings.

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>).