Garlic oil Clinical Trials

Size	Price	Qty
500mg	USD 70

Clinical Trials

A Phase 4 clinical trial, sponsored by Albany Medical College, was designed to evaluate how garlic oil macerate influences inflammatory mediators in healthy normal-weight and obese participants. Although recruitment for this trial is currently suspended, the study focuses on modulating physiological baseline parameters and inflammatory pathways rather than treating pathologic conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00275405	Suspended	Healthy	Albany Medical College	2006-04	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Garlic oil stimulates the induction of phase II drug-metabolizing enzymes, which accelerates the detoxification of tobacco-derived 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone, thereby preventing DNA adduct formation and inhibiting lung tumorigenesis. Beyond chemoprevention, this enzymatic induction mitigates systemic oxidative stress and downstream pro-inflammatory signaling pathways, supporting the evaluation of garlic oil to modulate inflammatory mediators in healthy individuals.

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>).