6-Gingerol Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials investigate 6-gingerol for dental and oral mucosal therapeutic applications, evaluating conditions such as lesion sterilization and tissue repair in non-vital primary molars alongside the management of oral lichen planus. Sponsored primarily by academic institutions including Al-Azhar University and Ain Shams University, these initiatives encompass Phase 4 research alongside unassigned phase protocols. Recruitment status across these studies ranges from currently recruiting to unknown, with focus placed on clinical and radiographic outcomes following local treatment interventions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07488416	RECRUITING	Clinical Outcomes; Radiographic Outcomes; Lesion Sterilization; Tissue Repair; Zinc Oxide; 6-gingerol; Triple Antibiotic Paste; Non-vital; Primary Molars	Al-Azhar University	2024-10-01
NCT05882864	UNKNOWN	Oral Lichen Planus	Ain Shams University	2023-08-01	PHASE4

(data from https://clinicaltrials.gov, updated on 2026-03-23)

Check the 6-Gingerol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a primary bioactive constituent of fresh ginger, 6-gingerol interacts with cellular targets to suppress key pro-inflammatory signaling pathways and reactive oxygen species generation, leading to reduced inflammatory cytokine production and diminished cellular oxidative stress. This anti-inflammatory and antioxidant activity mediates mucosal tissue protection and anti-neoplastic responses, providing therapeutic rationale for its clinical evaluation in managing mucosal inflammatory conditions such as oral lichen planus and promoting tissue repair in dental lesions.

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>).