Clinical Trials

Multiple clinical trials evaluate the therapeutic efficacy of borneol formulations for conditions including acute ischemic stroke, intracranial hemorrhages, post-stroke epilepsy, stable angina pectoris, and allergic rhinitis. Spanning Early Phase I through Phase III evaluations, these studies are sponsored by academic medical centers and pharmaceutical enterprises, such as Peking University Third Hospital and Yantai YenePharma Co., Ltd. Trial recruitment statuses range from completed investigations of sublingual formulations to upcoming studies that are not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07604350 NOT_YET_RECRUITING
Post-stroke Epilepsy; Post-stroke Seizure
First Affiliated Hospital of Wenzhou Medical University
 2026-06 PHASE3
NCT04950920 COMPLETED
Stroke
Peking University Third Hospital
 2021-06-28 PHASE3
NCT05901532 COMPLETED
Rhinitis, Allergic; Nasal Lavage; Medicine, Chinese Traditional
Taichung Veterans General Hospital
 2020-11-01 PHASE2
NCT03495206 UNKNOWN
Stroke, Acute; Intracranial Hemorrhages
Yantai YenePharma Co., Ltd.
 2018-10-25 PHASE1
NCT02029118 COMPLETED
Stable Angina Pectoris
Chengdu University of Traditional Chinese Medicine
 2012-10 EARLY_PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-22)

Check the (+)-Borneol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

(+)-Borneol functions as a bicyclic monoterpenoid that modulates GABA receptor activity and enhances blood-brain barrier penetration, thereby dampening inflammatory signaling pathways and neurovascular resistance. By suppressing neuroinflammation and oxidative damage in cerebral tissue, (+)-Borneol preserves neuronal cell viability, providing a therapeutic rationale for its investigation in acute stroke, intracranial hemorrhage, and post-stroke neurological sequelae.

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>).

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Note: Technical data last updated: Sep 1, 2026.