Salvianolic acid B Clinical Trials

Size	Price	Qty
1mg*5	USD 147
25mg	USD 397

Clinical Trials

A Phase 4 clinical trial evaluates combination therapy with aspirin and salvianolate injection for managing angina resulting from coronary heart disease. The study focuses on the population pharmacokinetics and clinical outcomes of Salvianolic acid B paired with standard antiplatelet therapy. Sponsored by academic and clinical research institutions, including the China Academy of Chinese Medical Sciences, the trial currently has an unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02694848	Unknown status	Angina	China Academy of Chinese Medical Sciences\|Xiyuan Hospital of China Academy of Chinese Medical Sciences\|Guang''anmen Hospital of China Academy of Chinese Medical Sciences\|General Hospital of Beijing PLA Military Region\|Guangdong Provincial Hospital of Traditional Chinese Medicine	2016-02	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Salvianolic acid B acts as a potent antioxidant and free radical scavenger, directly neutralizing reactive oxygen species to inhibit oxidative stress-driven lipid peroxidation and cellular injury in vascular endothelial cells. By protecting vascular cell integrity and mitigating ischemic tissue damage, this mechanism provides a therapeutic rationale for its clinical evaluation in cardiovascular conditions such as angina.

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>).