Clinical safety and efficacy of NG440: a novel combination of rho iso-alpha acids from hops, rosemary, and oleanolic acid for inflammatory conditions.

Abstract

In this report, we examine the clinical safety and efficacy of NG440, a phytochemical-based antiinflammatory formula consisting of a combination of rho iso-alpha acids from hops, rosemary, and oleanolic acid. In a previous study, we demonstrated that NG440 significantly decreased pain by 50% in patients with osteoarthritis. Consistent with these data, results from a multicentre trial indicate that NG440 reduced pain scores in patients with joint discomfort, as measured by VAS (visual analog scale) methodology. As demonstrated in an ex vivo clinical study, these effects on pain relief may be due to reduced inflammatory cytokine production including lower prostaglandin E2 formation. Finally, strong data exist to suggest that NG440 is a safe formula for human consumption. Animal toxicity data revealed no adverse effects of NG440 at dosages < or =250 mg.kg-1.day-1 for 21 days. Furthermore, human trial data suggest that NG440 does not negatively impact cardiovascular and gastrointestinal markers normally affected by selective COX-2 enzyme inhibitors, including platelet function, blood pressure, blood cell count, or fecal calprotectin, a measure of gastrointestinal injury. In conclusion, NG440 may serve as a safe and efficacious alternative in some areas where specific COX-2 inhibitors have been traditionally used.

• Authors: Deanna M Minich, Jeffrey S Bland, Jeffrey Katke, Gary Darland, Amy Hall, Robert H Lerman, Joseph Lamb, Brian Carroll, Matthew Tripp
• Journal: Canadian journal of physiology and pharmacology (Can J Physiol Pharmacol) Vol. 85 Issue 9 Pg. 872-83 (Sep 2007) ISSN: 0008-4212 [Print] Canada
• PMID: 18066133 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Cyclopentanes
• Drug Combinations
• Leukocyte L1 Antigen Complex
• Plant Extracts
• Naproxen
• Oleanolic Acid
• Dinoprostone

Topics

• Administration, Oral
• Animals
• Anti-Inflammatory Agents, Non-Steroidal (adverse effects, pharmacology, therapeutic use)
• Blood Cell Count
• Blood Coagulation (drug effects)
• Blood Pressure (drug effects)
• Cells, Cultured
• Cross-Over Studies
• Cyclopentanes (chemistry)
• Dinoprostone (biosynthesis, blood)
• Double-Blind Method
• Drug Combinations
• Feces (chemistry)
• Female
• Humans
• Humulus (chemistry)
• Kidney Function Tests
• Leukocyte L1 Antigen Complex (analysis)
• Liver Function Tests
• Male
• Mice
• Naproxen (adverse effects)
• Oleanolic Acid (adverse effects, pharmacology, therapeutic use)
• Pain (drug therapy)
• Plant Extracts (adverse effects, pharmacology, therapeutic use)
• Rheumatic Diseases (drug therapy)
• Rosmarinus (chemistry)