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Abstract

PROSPECTIVE OBSERVATIONAL PHASE IV OPEN LABEL STUDY TO COMPARE THE EFFECTIVENESS OF STANDARD TREATMENT TO TURMOCIN, TURMOCIN PLUS TABLET AS ADDON TO STANDARD TREATMENT IN OSTEOARTHRITIS

Dr.Vinit Jain, Dr.Satish Jain, Dr.Ashwin Porwal*, Vd.Swapnil Bhowate

ABSTRACT

Osteoarthritis the most common form of arthritis, and one of the leading causes of pain and disability worldwide. In Asian countries it is prevalence ranging from 38.1% to 46.8% and specifically in India study reported it as 28.7% in age >40 years. Common manifestations of osteoarthritis are pain which prominently treated with NSAIDS (non-steroidal anti-inflammatory drugs) and analgesic as current standard of care. Adverse events with NSAIDS reported are gastric ulceration, hemorrhage and perforation. United states food and drug administration(USFDA) has approved curcuminoids as Generally Recognized As Safe. At 95% concentration dose of curcuminoids: curcumin, bisdemethoxycurcumin, and demethoxycurcumin reported as safe. Turmocin and turmocin plus tablet used in this study in which addition of black pepper may help in increasing bioavailability. The primary objective of this study to compare the effect of turmocin, turmocin plus tablet as add on with current standard care of treatment in osteoarthritis patients. Secondary objective was to see effectiveness of Tablets with Haridra (Rhizome) Curcuma longa 500mg, Marich (Fruit) Piper nigrum 250mg and Haridra Ext, Curcumin 95% (Rhizome) Curcuma longa 500mg Marich (Fruit) Piper nigrum 250mg. WOMAC Osteoarthritis Index score were used for comparisons. Participants were also assessed for pain, stiffness, swelling, restricted movements in joints time duration, variation in pain also measured as per season and time of the day. Group III participants showed best results in WOMAC score with p value <0.001 mean (SD) as 1.78(0.93) using paired t test.

Keywords: STD= Standard Treatment, STD + T=Standard Treatment with add on Turmocin Tablet, STD + TP =Standard Treatment + Turmocin plus Tablet, PF= Physical function, RM= Restricted Movements.


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