Clinical Trials

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by academic institutions and medical centers, these studies encompass completed, recruiting, not yet recruiting, and withdrawn recruitment statuses.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.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rutin targets cellular inflammatory mediators and scavenges reactive oxygen species, blocking downstream oxidative stress signaling pathways and preserving endothelial cell integrity. This cellular cytoprotection and attenuation of capillary fragility provide the mechanistic foundation for its clinical investigation in microvascular and metabolic conditions, including chronic venous insufficiency and type 2 diabetes mellitus.

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.