Menthol Clinical Trials

Size	Price	Qty
100mg	USD 79
1g	USD 397

Clinical Trials

Several clinical trials evaluate the physiological and therapeutic effects of menthol across indications such as dyspnea in chronic obstructive pulmonary disease, tobacco use behaviors, and knee osteoarthritis pain. Sponsored by academic and governmental entities—including KU Leuven, Virginia Commonwealth University in collaboration with the National Institute on Drug Abuse, Memorial University of Newfoundland, and the University of Oklahoma—the studies range from non-interventional designs to Phase 2/Phase 3 trials. Encompassing actively recruiting, completed, and unknown recruitment statuses, these trials assess interventions such as menthol inhalation for dyspnea relief and topical menthol gel for osteoarthritis.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05785026	Recruiting	Dyspnea\|Chronic Obstructive Pulmonary Disease	KU Leuven	2023-01-01	Not Applicable
NCT05499377	Recruiting	Tobacco Use	Virginia Commonwealth University\|National Institute on Drug Abuse (NIDA)	2022-11-28	Not Applicable
NCT04351594	Unknown status	Knee Osteoarthritis	Memorial University of Newfoundland	2020-11-01	Phase 2\|Phase 3
NCT03953508	Completed	Smoking Cigarette	University of Oklahoma	2020-08-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Menthol interacts with thermo-sensitive cold receptors and inhibits calcium ion currents across neuronal membranes, thereby suppressing downstream nociceptive neural transmission. This attenuation of neuronal calcium influx dampens peripheral sensory signaling to produce localized cooling and analgesia, providing a biological rationale for its clinical investigation in managing knee osteoarthritis symptoms and relieving dyspnea in chronic obstructive pulmonary disease.

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>).