Kansui Radix Extract Clinical Trials

Size	Price	Qty
5mg	USD 70

Clinical Trials

A clinical trial evaluated the safety and immunologic response to a tea-formulated Kansui Radix Extract powder in HIV-infected individuals receiving suppressive antiretroviral therapy. Jointly sponsored by academic and non-profit organizations, including the University of California San Francisco, the University of Utah, and amfAR, this early-stage study is currently listed as terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02531295	Terminated	HIV\|Human Immunodeficiency Virus	University of California San Francisco\|University of Utah\|amfAR The Foundation for AIDS Research	2019-05-15	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Kansui Radix Extract contains bioactive diterpenoid compounds that modulate protein kinase C signaling cascades, thereby promoting downstream nuclear factor activation and cellular gene expression. This intracellular activation stimulates viral transcription within latent human immunodeficiency virus (HIV) reservoirs, supporting potential viral reactivation strategies aimed at immune targeting and clearance.

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>).