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)
Mechanism and Biochemical Profile
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>).