Efficacy of a Patented Menthol‐Fortified Phytochemical Formulation in the Alleviation of Joint Pain and Inflammation in Human Subjects: A Clinical Investigation of HerboJoint

Abstract

Standardized botanical formulations have often yielded promising results in the treatment of debilitating joint pains such as those encountered in Osteoarthritis (OA) and Rheumatoid Arthritis (RA). We report a novel formulation of essentials oils made from the Generally Recognized as Safe (GRAS) family of plants widely used in Ayurveda namely Kattrna (CC‐Cymbopogon citratus) (3.0%), Sati (Hedychium spicatum) (1.0%) and Tumuru (ZA‐ Zanthoxylum alatum) oil (1.0%) along with Menthol (M‐ Mentha arvensis) (1.3%) in a non‐greasy cream base which can provide relief against joint pains arising out of arthritis. The formulation was designed as a topical cream for applying around the affected joint. Its purity was confirmed through HPLC and GC‐MS analysis by comparing with identifiable marker components. The formulation patented as HerboJoint was able to substantially bring down the levels of inflammatory cytokines TNF‐α, IL‐6 and IL‐1β in a Type II collagen induced mouse arthritis model. In human clinical trials, the formulation significantly decreased joint pain, joint swelling and joint stiffness arising out of Osteoarthritis and Rheumatoid Arthritis by 2.2, 2.7 and 3.6 times respectively and provided relief to about 90% of patients selected randomly. The corresponding TNF‐α levels in the sera of patients also decreased substantially thus indicating that the formulation was effective in management of both OA and RA. The present invention based on synergistic action of Essential Oils and Menthol is believed to provide a significant relief to these extremely painful and potentially incurable medical conditions.