EVALUATION OF THE EFFICACY AND SAFETY OF TABLET BONIVIA OA IN KNEE OSTEOARTHRITIS: A RANDOMIZED CONTROLLED CLINICAL STUDY

Osteoarthritis (OA), a leading cause of disability in the aging population, is increasingly prevalent due to rising obesity and longer life expectancy. Despite advances in OA management, regeneration of articular cartilage in an inflammatory environment remains a major therapeutic challenge. Current non-pharmacological measures—patient education, exercise, and weight control—remain foundational, while pharmacological options like NSAIDs and paracetamol offer only symptomatic relief with limited efficacy and safety concerns . No drug currently halts OA progression, prompting the FDA in 2018 to recognize OA as a “serious disease with an unmet medical need” . OA is now acknowledged as a multifactorial joint disease marked by inflammation, cartilage degradation, synovitis, and subchondral bone changes.  In Ayurveda, OA is described as Sandhigata Vata, a condition of joint pain, swelling, crepitus, and restricted movement, primarily due to aggravated Vata dosha [12]. It is classified as Vatavyadhi and is more prevalent in old age, making it Kashtasadhya (difficult to treat). The Ministry of AYUSH, through the NAMASTE portal, recognizes OA as a research priority for integrative care. Bonivia OA is a polyherbal Ayurvedic formulation aimed at the multidimensional pathology of OA. Its ingredients—Ashwagandha (Withania somnifera), Guduchi (Tinospora cordifolia), Gokshura (Tribulus terrestris), Nirgundi (Vitex negundo), Dashamoola, Shankhabhasma, and Mahayograj Guggulu—possess anti-inflammatory, immunomodulatory, and chondroprotective actions. The formulation balances aggravated Vata using Laghu (light), Snigdha (unctuous), and Ushna (hot) properties to counter Ruksha and Sheeta qualities. Its bitter, pungent, and astringent taste supports Shothaghna (anti-inflammatory), Shoolaghna (analgesic), and Bruhan (nourishing) effects. Bonivia OA thus provides a holistic, evidence-backed, and safer alternative to conventional therapies, aligning with Ayurvedic principles while addressing modern clinical needs in OA management. The current study focusses on efficacy of tablet Bonivia OA on knee osteoarthritis with the help of parameters like clinical symtoms, WOMAC Index Score, Numeric Pain Rating Scale, SF-12 questionnaire and inflammtory bio markers such as PGE-II, CTX, IL-6. The safety of the drug will aslo be evaulated using hematological investigations like Liver function tests, blood ureal leves and serum creatinine.