Gastrodin Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

A Phase 4 clinical trial sponsored by Huazhong University of Science and Technology was designed to evaluate the therapeutic impact of gastrodin in patients with cognitive decline. Although the trial's recruitment status is currently listed as unknown, this investigation underscores the ongoing exploration of gastrodin for managing central nervous system disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00297245	Unknown status	Cognitive Decline	Huazhong University of Science and Technology	2006-02	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gastrodin acts as an anti-inflammatory glucoside that suppresses neuroinflammatory signaling and mitigates oxidative stress in neural tissues, thereby reducing cellular damage following cerebral ischemic injury. This neuroprotective mechanism underlies its therapeutic relevance in clinical investigations aimed at ameliorating cognitive decline and treating neurodegenerative conditions.

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>).