Multiple clinical trials evaluate the anti-inflammatory and neuroprotective effects of luteolin across diverse conditions, including neurological and cognitive disorders, metabolic syndrome, Gulf War illness, and tongue neoplasms. Ranging from Early Phase 1 to Phase 2 studies and nutritional evaluations, these protocols are sponsored by academic and medical institutions, such as Attikon Hospital, Cairo University, and the University of Alabama at Birmingham. Recruitment statuses for these behavioral and cognitive investigations range from completed and enrolling by invitation to not yet recruiting and terminated.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07681063 | NOT_YET_RECRUITING | Postoperative Cognitive Dysfunction |
Fondazione IRCCS San Gerardo dei Tintori |
2026-06 | |
| NCT06777680 | NOT_YET_RECRUITING | Acute Ischemic Stroke AIS |
Ospedali Riuniti Trieste |
2025-01 | |
| NCT05204407 | COMPLETED | Schizophrenia; Schizoaffective Disorder |
University of Maryland, Baltimore |
2022-06-13 | |
| NCT07280520 | ENROLLING_BY_INVITATION | Healthy Athletes |
University of Jordan |
2025-11-01 | |
| NCT06047899 | COMPLETED | Memory |
Prof. Dominique de Quervain, MD |
2023-11-28 | |
| NCT04489017 | COMPLETED | Frontotemporal Dementia |
I.R.C.C.S. Fondazione Santa Lucia |
2019-06-01 | PHASE2 |
| NCT05311852 | COMPLETED | Fatigue; Cognitive Deficit; COVID-19; Neurophysiologic Abnormality |
Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy |
2021-08-16 | |
| NCT04468854 | TERMINATED | Memory |
University of Basel |
2020-01-01 | |
| NCT02909686 | COMPLETED | Gulf War Illness |
University of Alabama at Birmingham |
2016-07 | |
| NCT03288298 | UNKNOWN | Tongue Neoplasms; Carcinoma |
Cairo University |
2017-11-01 | EARLY_PHASE1 |
| NCT03444558 | COMPLETED | Metabolic Syndrome |
University of Palermo |
2017-06-01 | |
| NCT01847521 | COMPLETED | Autism Spectrum Disorders |
Attikon Hospital |
2011-12 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-07-02)
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>).