Clinical Trials

Several clinical trials evaluate interventions associated with this compound dataset across diverse conditions, including midshaft clavicle fractures, elevated perimenopausal blood pressure, and pediatric primary care HIV testing protocols. Designated as Phase Not Applicable, these studies are led by academic or institutional sponsors, including the University of Minnesota, The University of Texas Medical Branch Galveston, and Yale University in partnership with the National Institute of Mental Health. None are currently recruiting, with individual statuses listed as either suspended or not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05454306 Suspended
Clavicle Fracture
University of Minnesota
2028-01-09 Not Applicable
NCT06376812 Not yet recruiting
Elevated Blood Pressure|Perimenopause
The University of Texas Medical Branch Galveston
2026-05 Not Applicable
NCT06279949 Not yet recruiting
Hiv
Yale University|National Institute of Mental Health (NIMH)
2026-04 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Picroside I, an iridoid glycoside, modulates inflammatory and oxidative stress signaling by suppressing pro-inflammatory cytokine secretion and inhibiting cellular lipid peroxidation, thereby preventing apoptotic cell death and maintaining tissue homeostasis. This broad hepatoprotective, antioxidant, and antimicrobial activity provides cellular defense relevant to viral pathologies such as HIV, as well as tissue preservation and physiological recovery in conditions involving elevated blood pressure and fracture repair.

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>).

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