Ginger Extract(1%) Clinical Trials

Size	Price	Qty
5mg	USD 89

Clinical Trials

Multiple completed clinical trials have evaluated the biological effects and clinical utility of ginger extract for indications including adjunctive therapy for periodontal pockets, control of postprandial hyperglycemia, and management of anxiety and depression. Conducted by academic sponsors—such as Ain Shams University, Egas Moniz - Cooperativa de Ensino Superior CRL, and the University of Washington—these studies encompass Phase 2 trials as well as trials without formal phase designations, reflecting interest in the extract's anti-inflammatory and metabolic properties.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06200415	Completed	Periodontal Pocket	Ain Shams University	2022-11-08	Phase 2
NCT05152745	Completed	Hyperglycemia Postprandial	Egas Moniz - Cooperativa de Ensino Superior CRL	2017-05-05	Not Applicable
NCT02497755	Completed	Anxiety\|Depression	University of Washington	2015-07	Not Applicable

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

Check the Ginger Extract(1%) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ginger Extract(1%), derived from Zingiber officinale Roscoe, regulates STAT6 and TNF-α signaling pathways while providing antioxidant activity to inhibit pro-inflammatory mediator release and cellular oxidative stress. This attenuation of chronic inflammation and reactive oxygen species mitigates tissue breakdown and metabolic dysfunction, providing a mechanistic rationale for its clinical investigation in postprandial hyperglycemia and periodontal pocket management.

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>).