Numerous clinical trials spanning Phase 1 through Phase 4 evaluate Rutin across vascular, metabolic, and oncological conditions, including chronic venous insufficiency, hemorrhoidal disease, type 2 diabetes mellitus, non-alcoholic fatty liver disease, and muscle-invasive bladder cancer. Predominantly sponsored by academic institutions and medical centers, these studies encompass completed, recruiting, not yet recruiting, and withdrawn recruitment statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07310407 | NOT_YET_RECRUITING | NAFLD |
Ain Shams University |
2026-01-01 | PHASE2 |
| NCT06718452 | NOT_YET_RECRUITING | Tinnitus; Neuroinflammation |
University of Campania Luigi Vanvitelli |
2026-04-20 | |
| NCT07689214 | RECRUITING | Diabete Type 2 |
University of Roma La Sapienza |
2024-07-17 | |
| NCT07564999 | ENROLLING_BY_INVITATION | The Aim is to Strengthen Disaster Preparedness Knowledge and Skills Through Peer Interaction |
Selcuk University |
2026-05-15 | |
| NCT06916494 | RECRUITING | Muscle Invasive Bladder Cancer |
First Affiliated Hospital of Chongqing Medical University |
2025-05-01 | PHASE1 |
| NCT06705777 | COMPLETED | Haemorrhoidal Disease |
Fundação Educacional Serra dos Órgãos |
2024-09-01 | PHASE4 |
| NCT07370220 | COMPLETED | Ulcerative Colitis |
Benha University |
2025-02-22 | PHASE2 |
| NCT06579482 | COMPLETED | Chronic Venous Insufficiency |
Fundação Educacional Serra dos Órgãos |
2024-11-06 | PHASE4 |
| NCT07518355 | COMPLETED | Healthly Volunteers |
China Medical University Hospital |
2024-10-30 | |
| NCT07147842 | COMPLETED | Ulcerative Colitis |
Benha University |
2024-11-01 | |
| NCT05387252 | UNKNOWN | Vaccine Adverse Reaction; Side-Effect |
Taipei Medical University |
2022-05-31 | |
| NCT04955145 | UNKNOWN | End Stage Renal Disease |
Ain Shams University |
2021-06-20 | PHASE3 |
| NCT04669977 | UNKNOWN | Chemotherapy-induced Peripheral Neuropathy |
Taipei Medical University |
2020-12-02 | |
| NCT04161872 | COMPLETED | Hyperuricemia |
University of Pavia |
2018-10-01 | PHASE4 |
| NCT03437902 | COMPLETED | Type 2 Diabetes Mellitus |
Ain Shams University |
2018-02-24 | PHASE2; PHASE3 |
| NCT01847521 | COMPLETED | Autism Spectrum Disorders |
Attikon Hospital |
2011-12 | PHASE2 |
| NCT00003365 | TERMINATED | Colorectal Cancer |
University of Medicine and Dentistry of New Jersey |
1996-08 | |
| NCT01254006 | COMPLETED | Glaucoma |
University of Roma La Sapienza |
(data from https://clinicaltrials.gov, updated on 2025-12-30)
Check the
Rutin
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.