Asarinin Clinical Trials

Size	Price	Qty
1mg	USD 127

Clinical Trials

A clinical trial is currently evaluating the therapeutic potential of sesamin supplementation for sleeping disorders, specifically assessing its impact on sleep quality and antioxidative status in patients with low arousal threshold obstructive sleep apnea syndrome. Sponsored by an academic institution, Taipei Medical University, this study operates without a defined phase classification and is actively recruiting participants. This ongoing research underscores early clinical interest in utilizing the dietary supplement to enhance sleep parameters and cellular oxidative balance in respiratory conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05678439	Recruiting	Sleeping Disorders	Taipei Medical University	2022-11-18	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Asarinin functions as a lipophilic antioxidant and metabolic regulator that suppresses intracellular reactive oxygen species generation, thereby inhibiting downstream lipid peroxidation and inflammatory signaling cascades. This attenuation of cellular oxidative stress preserves vascular and tissue homeostasis, providing a rational biochemical foundation for its investigation in clinical trials targeting sleeping disorders and systemic oxidative imbalances.

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>).