Echinacoside Clinical Trials

Size	Price	Qty
10mg	USD 97

Clinical Trials

A clinical trial is on record evaluating Echinacoside in a phase 1, single-center, randomized, double-blind, placebo-controlled dose-escalation study conducted in healthy volunteers to assess early-stage safety, tolerability, and pharmacokinetics. Sponsored by The Affiliated Hospital of Qingdao University, an academic clinical center, the study aims to establish baseline profiles prior to disease-specific testing. Currently, the recruitment status of this trial is categorized as unknown in official registries.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04902534	UNKNOWN	Healthy Volunteers	The Affiliated Hospital of Qingdao University	2020-08-05	PHASE1

(data from https://clinicaltrials.gov, updated on 2021-05-26)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Echinacoside activates tropomyosin receptor kinase (Trk) receptors to trigger neuroprotective signaling cascades while simultaneously scavenging nitric oxide and reactive oxygen species to reduce cellular oxidative stress. This downstream suppression of inflammatory and degenerative pathways underpins its physiological activity, supporting phase 1 clinical evaluations of safety, tolerability, and pharmacokinetics in healthy volunteers.

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>).