Garlic Extract Clinical Trials

Size	Price	Qty
5mg	USD 79

Clinical Trials

A Phase 2/Phase 3 clinical trial sponsored by Suez Canal University evaluated the therapeutic potential of garlic extract (*Allium sativum*) for infected root canals. The study investigated the comparative antibacterial efficacy of *Allium sativum* alone and in combination with calcium hydroxide as intracanal medicaments. This trial has completed recruitment, contributing valuable clinical data regarding the drug effects of garlic-based preparations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05050071	Completed	Drug Effect	Suez Canal University	2019-10-08	Phase 2\|Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bioactive organosulfur components within Garlic Extract interact with microbial and metabolic targets to inhibit key sulfhydryl-containing enzymes, thereby disrupting downstream cellular signaling and lipid biosynthetic pathways. This biochemical suppression impairs pathogen survival and alters metabolic regulation, driving the clinical drug effects and antibacterial efficacy investigated in patient 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>).