Sinomenine Clinical Trials

Size	Price	Qty
100mg	USD 79
1g	USD 317

Clinical Trials

Sinomenine has been evaluated in a clinical trial investigating its therapeutic potential for articular disorders, specifically a Phase 3 study comparing its safety and efficacy against standard glucocorticoid treatment in patients with early knee osteoarthritis. Sponsored by Shanghai 6th People's Hospital, an academic medical center, the trial's recruitment status is presently recorded as unknown. This advanced-stage research highlights ongoing efforts to confirm the clinical utility of Sinomenine in managing knee osteoarthritis.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05764304	UNKNOWN	Knee Osteoarthritis	Shanghai 6th People's Hospital	2023-02-28	PHASE3

(data from https://clinicaltrials.gov, updated on 2023-03-10)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sinomenine stimulates histamine release and inhibits the enzymatic synthesis of key pro-inflammatory mediators, including prostaglandins, leukotrienes, and nitric oxide, thereby blocking downstream inflammatory cascades and suppressing cellular immune activation. This reduction in local mediator production attenuates tissue destruction and alleviates joint pain, providing a rationale for its clinical application in managing knee osteoarthritis.

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>).