Caffeic Acid Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials evaluate caffeic acid across conditions including acute ischemic stroke, advanced esophageal cancer, and primary immune thrombocytopenia. Sponsored by academic and clinical medical centers, these mid- to late-stage evaluations encompass Phase 2/3, Phase 3, and Phase 4 trials. Recruitment statuses for these studies range from completed investigations to those that are unknown or not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05560152	Not yet recruiting	Ischemic Stroke Acute	Ying Gao\|Dongzhimen Hospital of Beijing University of Chinese Medicine Beijing\|Dongzhimen Hospital Beijing	2022-09-25	Phase 2\|Phase 3
NCT04648917	UNKNOWN	Esophagus Cancer, Stage III	The First Affiliated Hospital of Henan University of Science and Technology	2019-05-01	PHASE3
NCT03070262	UNKNOWN	Esophagus Cancer	The First Affiliated Hospital of Henan University of Science and Technology	2017-01	PHASE3
NCT02556814	COMPLETED	Immune Thrombocytopenia	Shandong University	2015-09	PHASE4
NCT02351622	COMPLETED	Immune Thrombocytopenia	Shandong University	2012-09	PHASE3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Caffeic acid directly inhibits the 5-lipoxygenase enzyme and TRPV1 ion channels, suppressing arachidonic acid metabolism and subsequent leukotriene biosynthesis to reduce oxidative stress and downstream inflammatory signaling. This biochemical inhibition attenuates pro-inflammatory cellular cascades and aberrant cell proliferation, providing a mechanistically relevant rationale for its clinical evaluation in conditions such as immune thrombocytopenia, advanced esophageal cancer, and acute ischemic stroke.

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>).