Clinical Trials

Several clinical trials evaluate the therapeutic efficacy and safety of Ginsenoside Rg3 in oncology, focusing on early-stage and general hepatocellular carcinoma along with self-efficacy outcomes in advanced solid tumors. Featuring Phase II and non-phase designated designs, these studies assess Rg3 capsule monotherapy as well as combination strategies with chemotherapy or arterial chemoembolization. Sponsored by entities including ShenFeng, Hebei Tumor Hospital, and Eastern Hepatobiliary Surgery Hospital, recruitment status across these trials ranges from completed to unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04523467 UNKNOWN
Hepatocellular Carcinoma
Eastern Hepatobiliary Surgery Hospital
 2020-12-01
NCT01757366 UNKNOWN
Self Efficacy
Hebei Tumor Hospital
 2012-12 PHASE2
NCT01717066 COMPLETED
Stage I Hepatocellular Carcinoma; Stage II Hepatocellular Carcinoma
ShenFeng
 2012-04

(data from https://clinicaltrials.gov, updated on 2020-08-21)

Check the Ginsenoside Rg3 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ginsenoside Rg3 interacts with membrane signaling receptors and vascular endothelial growth factor pathways to inhibit downstream pro-survival signaling cascades, thereby suppressing cell proliferation and inducing apoptosis in malignant cells. This anti-angiogenic and pro-apoptotic activity provides the mechanistic basis for its investigation in clinical trials targeting hepatocellular carcinoma and advanced solid tumors.

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>).

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