Clinical Trials

Multiple completed clinical trials without assigned phase designations have evaluated the therapeutic potential of naringin and naringin-containing interventions. Sponsored by both academic institutions and industry organizations, these studies investigated applications in post-menopausal health—focusing on vascular protection and bone metabolism—and body composition management using thermogenic supplements.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01423019 COMPLETED
Weight Loss
Integrative Health Technologies, Inc.
 2011-10
NCT01272167 COMPLETED
Post-menopausal Status
University Hospital, Clermont-Ferrand
 2010-03

(data from https://clinicaltrials.gov, updated on 2012-01-23)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Naringin binds to and inhibits key metabolic enzymes, including cytochrome P450 isoforms such as CYP3A4 and CYP1A2, while modulating downstream pathways governing lipid homeostasis and oxidative stress. This enzymatic inhibition and antioxidant signaling attenuate cellular lipid accumulation and oxidative cell damage, providing a mechanistic rationale for its clinical investigation in weight loss and vascular protection in post-menopausal status.

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.