Numerous clinical trials evaluate epigallocatechin and related green tea polyphenols across diverse dermatological, neurodegenerative, and oncological conditions, including acne vulgaris, radiation dermatitis, small cell lung carcinoma, Alzheimer's disease, traumatic brain injury, frailty, and systemic inflammation. Spanning Early Phase 1 through Phase 4, these investigations are sponsored by academic institutions and medical centers, such as Seoul National University Hospital, Charité University, and the University of Rochester. Current recruitment statuses across the dataset encompass completed, recruiting, and suspended studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06068543 | SUSPENDED | Frailty; Inflammation |
University of Rochester |
2024-10-25 | PHASE2 |
| NCT06015022 | RECRUITING | Cirrhosis, Liver |
University of Texas Southwestern Medical Center |
2024-09-01 | PHASE2 |
| NCT07697196 | NOT_YET_RECRUITING | HPV Infection; HPV Integration; HPV Disease; HPV Genital Infection; HPV Persistence; Low Grade Squamous Intraepithelial Lesions of the Cervix |
IRCCS San Raffaele |
2026-07 | |
| NCT07149506 | ENROLLING_BY_INVITATION | Radiation Dermatitis Acute; Radiation Dermatitis; Fibrosis; Skin |
CARLOS FRANCISCO SAAVEDRA GARCIA |
2025-09-01 | PHASE3 |
| NCT05364008 | ACTIVE_NOT_RECRUITING | Leiomyoma, Uterine |
Yale University |
2023-01-05 | PHASE3 |
| NCT05409872 | COMPLETED | Leiomyoma, Uterine |
Universita di Verona |
2022-09-15 | |
| NCT06398405 | UNKNOWN | Esophageal Cancer; Dysphagia, Esophageal; Epigallocatechin Gallate |
Shandong Cancer Hospital and Institute |
2024-04-22 | PHASE2 |
| NCT05195918 | COMPLETED | Idiopathic Pulmonary Fibrosis |
Hal Chapman |
2023-08-24 | PHASE1 |
| NCT07725900 | COMPLETED | Hyperpigmentation; Dry Skin; Erythema |
Naniek Widyaningrum |
2025-12-01 | PHASE2; PHASE3 |
| NCT05448365 | RECRUITING | Uterine Fibroids; D-chiro-inositol; Inositol; Epigallocatechin Gallate; Vitamin D; Vitamin B6 |
Lo.Li.Pharma s.r.l |
2022-07-01 | |
| NCT06285357 | RECRUITING | HPV Infection |
Lo.Li.Pharma s.r.l |
2024-02-19 | |
| NCT05811403 | COMPLETED | Irreversible Pulpitis |
Cairo University |
2023-07-01 | |
| NCT06531863 | RECRUITING | Mood Disturbance |
Auburn University |
2024-09-30 | EARLY_PHASE1 |
| NCT06524609 | UNKNOWN | Chemotherapy-induced Peripheral Neuropathy |
Han Xi Zhao |
2023-11-30 | PHASE1; PHASE2 |
| NCT05988788 | COMPLETED | Necrotic Pulp |
Cairo University |
2023-10-01 | |
| NCT02891538 | COMPLETED | Colon Cancer |
The University of Texas Health Science Center at San Antonio |
2017-01-31 | EARLY_PHASE1 |
| NCT04553666 | COMPLETED | Frailty; Inflammation |
University of Rochester |
2021-04-28 | PHASE2 |
| NCT01744587 | COMPLETED | NPC |
National Health Research Institutes, Taiwan |
2013-04 | |
| NCT05625308 | COMPLETED | Papilloma; Cervix Lesion |
Lo.Li.Pharma s.r.l |
2022-07-01 | |
| NCT05116098 | UNKNOWN | Tuberculosis |
Ministry of Health, Saudi Arabia |
2021-11-30 | PHASE1 |
| NCT02577393 | UNKNOWN | Lung Neoplasms; Esophagitis; Prevention & Control; Epigallocatechin Gallate |
Shandong Cancer Hospital and Institute |
2015-04 | PHASE2 |
| NCT05349903 | COMPLETED | Appetitive Behavior; Obesity; Diabetes Mellitus, Type 2 |
Purdue University |
2021-11-10 | |
| NCT04177693 | COMPLETED | Uterine Fibroids |
Yale University |
2020-11-24 | PHASE1 |
| NCT03883880 | TERMINATED | Diet, Food Choice, Taste |
Purdue University |
2019-01-05 | |
| NCT02887950 | TERMINATED | Overweight |
Fondazione IRCCS Policlinico San Matteo di Pavia |
2016-09 | |
| NCT02580279 | UNKNOWN | Breast Neoplasms; Dermatitis; Prevention & Control; Epigallocatechin Gallate |
Shandong Cancer Hospital and Institute |
2014-12 | PHASE2 |
| NCT03928847 | COMPLETED | Idiopathic Pulmonary Fibrosis |
Hal Chapman |
2017-12-01 | EARLY_PHASE1 |
| NCT03740295 | COMPLETED | Multiple Sclerosis |
Fundación Universidad Católica de Valencia San Vicente Mártir |
2018-10-05 | PHASE2 |
| NCT01183767 | COMPLETED | Duchenne Muscular Dystrophy |
Charite University, Berlin, Germany |
2010-12-30 | PHASE2; PHASE3 |
| NCT02015312 | COMPLETED | Light Chain (AL) Amyloidosis; Cardiac Involvement |
Florian Michel |
2013-04 | PHASE2 |
| NCT03194620 | COMPLETED | Healthy |
University of California, Davis |
2016-08 | |
| NCT02558933 | COMPLETED | Fetal Alcohol Syndrome (FAS) |
Fundacion Clinic per a la Recerca Biomédica |
2016-03 | |
| NCT01511263 | TERMINATED | Primary Amyloidosis of Light Chain Type |
Fondazione IRCCS Policlinico San Matteo di Pavia |
2012-01 | PHASE2 |
| NCT00799890 | COMPLETED | Multiple Sclerosis |
Friedemann Paul |
2009-05 | PHASE2; PHASE3 |
| NCT03199430 | COMPLETED | EGCG Influence on Catecholamine Metabolism |
Swansea University |
2015-09 | PHASE4 |
| NCT00434499 | WITHDRAWN | Hypertension; Obesity; Type 2 Diabetes; Insulin Resistance |
University of Maryland, Baltimore |
2007-02 | PHASE2 |
| NCT02731495 | COMPLETED | Traumatic Brain Injury |
National Nutrition and Food Technology Institute |
2015-03 | PHASE2; PHASE3 |
| NCT01357681 | COMPLETED | Huntington Disease |
Charite University, Berlin, Germany |
2011-09 | PHASE2 |
| NCT00951834 | COMPLETED | Alzheimer's Disease |
Charite University, Berlin, Germany |
2009-10 | PHASE2; PHASE3 |
| NCT02147041 | UNKNOWN | Diabetes Mellitus; Hyperlipidemia |
Taipei City Hospital |
2012-05 | PHASE2; PHASE3 |
| NCT01699711 | COMPLETED | Down Syndrome (DS) |
Parc de Salut Mar |
2012-02 | PHASE2 |
| NCT00951964 | COMPLETED | Epidermolysis Bullosa Dystrophica |
Centre Hospitalier Universitaire de Nice |
2010-10 | PHASE2 |
| NCT00525668 | COMPLETED | Relapsing-remitting Multiple Sclerosis |
Charite University, Berlin, Germany |
2007-09 | PHASE1; PHASE2 |
| NCT01394796 | COMPLETED | Down Syndrome |
Parc de Salut Mar |
2010-05 | PHASE2 |
| NCT00981292 | COMPLETED | Cognitive Function; Mood |
Northumbria University |
2009-08 | PHASE4 |
| NCT01687556 | COMPLETED | Acne Vulgaris |
Seoul National University Hospital |
2005-07 | |
| NCT00153790 | COMPLETED | Weight Loss |
The Cooper Institute |
2005-04 | PHASE1 |
| NCT00476138 | UNKNOWN | Primary Open Angle Glaucoma; Ocular Hypertension |
Catholic University of the Sacred Heart |
2006-11 | PHASE1; PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-06-26)
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>).
- (-)-epigallocatechin Solubility in DMSO
- (-)-epigallocatechin Stock Solution
- (-)-epigallocatechin Storage
- (-)-epigallocatechin Stability
- (-)-epigallocatechin Molecular Weight
- (-)-epigallocatechin SMILES
- (-)-epigallocatechin CAS Number
- (-)-epigallocatechin Chemical Structure (2D and 3D)
- (-)-epigallocatechin SDS|MSDS