Baohuoside I Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Clinical evaluation of Baohuoside I remains limited, with a clinical trial investigating the safety, pharmacokinetics, and pharmacodynamics of escalating doses. Sponsored by the National University Hospital Singapore, this Phase 1 study targets osteoporosis and cardiovascular disease, though its recruitment status is currently unknown. Overall, this reflects preliminary clinical interest in evaluating the therapeutic potential and physiological effects of Baohuoside I for cardiovascular and bone health.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02931305	Unknown status	Osteoporosis\|Cardiovascular Disease	National University Hospital Singapore	2016-10	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Baohuoside I modulates reactive oxygen species generation and inhibits mitogen-activated protein kinase pathway activation, thereby suppressing intracellular signaling and inducing cytotoxic or anti-inflammatory cell responses. This molecular mechanism provides a rationale for its therapeutic investigation in clinical conditions such as osteoporosis and cardiovascular 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>).