Clinical Trials

Multiple clinical trials evaluate the therapeutic potential of escin across diverse inflammatory and postoperative conditions, including hemorrhoids, coronavirus infections, and dental procedure sequelae such as pain, facial edema, and trismus. These investigational protocols span Early Phase 1, Phase 2, and Phase 3 trials, with recruitment statuses ranging from recruiting and enrolling by invitation to completed and unknown. Key academic and institutional sponsors driving these evaluations include Chiang Mai University, the University of L'Aquila, the Oman Medical Speciality Board, the University of Catanzaro, and the University of Science and Technology, Yemen.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07244029 RECRUITING
Postoperative Pain; Facial Swelling; Trismus
Oman Medical Speciality Board
2026-01-01
NCT06748014 ENROLLING_BY_INVITATION
Hemorrhoid
Chiang Mai University
2024-12-20 EARLY_PHASE1
NCT07304882 COMPLETED
Impacted Mandibular Third Molar Extraction; Post Operative Complications
University of Science and Technology, Yemen
2023-11-30 PHASE3
NCT06363513 UNKNOWN
Anorectal Disorder
Chiang Mai University
2024-04
NCT04657874 COMPLETED
Postoperative Pain; Edema; Swelling Lips & Face
University of L'Aquila
2020-12-01
NCT04322344 UNKNOWN
Coronavirus Infections
University of Catanzaro
2020-03-23 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2026-01-15)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Escin acts as a saponin mixture that inhibits endothelial lysosomal enzymes and vascular hyperpermeability, thereby reducing fluid exudation and maintaining microvascular wall integrity. This vasoprotective and anti-inflammatory activity suppresses capillary leakage and tissue swelling, providing a direct biochemical foundation for its clinical use in alleviating postoperative pain, edema, and hemorrhoidal complications.

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>).

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