Rosmarinic acid Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Multiple completed clinical trials have evaluated rosmarinic acid formulations in human populations. These include a Phase 2 institutional trial sponsored by Hamilton Health Sciences Corporation examining high-rosmarinic acid mint tea for adults with nasal polyps, and a Phase 4 academic trial conducted by the University of Guelph investigating high-rosmarinic acid spearmint tea for knee osteoarthritis. Together, these studies demonstrate an exploratory focus on the anti-inflammatory and symptom-modifying therapeutic potential of rosmarinic acid in chronic inflammatory and degenerative conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01380015	COMPLETED	Osteoarthritis of the Knee	University of Guelph	2011-07	PHASE4
NCT00465543	COMPLETED	Nasal Polyps	Hamilton Health Sciences Corporation	2007-05	PHASE2

(data from https://clinicaltrials.gov, updated on 2013-01-23)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rosmarinic acid suppresses IKK-β activity within NF-κB activation signaling and directly inhibits lipoxygenase and cyclooxygenase enzymes, thereby downregulating inflammatory chemokine expression including CCL11 and CCR3 while blocking complement fixation. This multi-target inhibition suppresses downstream pro-inflammatory signaling cascades and immune cell recruitment, providing a mechanistic basis for its clinical evaluation in chronic inflammatory conditions such as nasal polyps and osteoarthritis of the knee.

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>).