Clinical Trials

Multiple clinical trials evaluate proanthocyanidins across diverse health conditions, including gingivitis, periodontitis, postprandial hyperglycemia, abdominal obesity, and recurrent urinary tract infections. Spanning Phase 1, Phase 2, Phase 4, and unassigned phases, these studies report recruitment statuses that are predominantly completed or unknown. The trials are sponsored primarily by academic and medical research institutions, including Laval University, the University of Seville, and the Lithuanian University of Health Sciences.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05062954 COMPLETED
Abdominal Obesity
Laval University
 2021-10-21
NCT06352099 COMPLETED
Cognitive Impairment; Old Age; Debility
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
 2024-05-02
NCT05109455 COMPLETED
Kidney Transplant Infection
Arafarma Group, S.A.
 2019-04-16 PHASE4
NCT05015387 COMPLETED
Periodontitis, Adult
Lithuanian University of Health Sciences
 2019-01-09 PHASE2
NCT02572895 UNKNOWN
Urinary Tract Infections
Laval University
 2015-08 PHASE1
NCT05140629 Completed
Hyperglycemia Postprandial
Egas Moniz - Cooperativa de Ensino Superior CRL
 2017-01-02 Not Applicable
NCT03030716 COMPLETED
Iron Deficiency Anemia; Iron-deficiency
Kansas State University
 2016-06-25
NCT02515929 COMPLETED
Gingivitis
University of Seville
 2013-09 PHASE4
NCT01688154 COMPLETED
Triglyceride Metabolism; Cardiovascular Function
Technological Centre of Nutrition and Health, Spain
 2013-02
NCT01219595 COMPLETED
Urinary Tract Infection
University of Wisconsin, Madison
 2010-09
NCT00742287 COMPLETED
Smoking
Maastricht University Medical Center
 2009-02

(data from https://clinicaltrials.gov, updated on 2026-08-26)

Check the Proanthocyanidins product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Proanthocyanidins function as potent polyphenolic antioxidants that directly scavenge reactive oxygen species and attenuate pro-inflammatory signaling pathways. By suppressing oxidative cellular damage and tissue inflammation, these condensed tannins support vascular endothelial integrity and mucosal protection, directly linking to their investigated clinical applications in periodontitis, postprandial hyperglycemia, and urinary tract infections.

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>).

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Note: Technical data last updated: Sep 1, 2026.