NTERNATIONAL J OURNAL OF P HARMACY & L IFE S CIENCES To assess the efficacy & safety of NILIN TM SR tablets in the management of osteoarthritis of knee
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چکیده
To assess the efficacy & safety of NilinTM SR tablets in the management of osteoarthritis of knee. 32 subjects from the age group 40-65 years having osteoarthritis of the knee, with no other rheumatologic condition were enrolled. Subjects were judged to have osteoarthritis with clinical diagnostic features; Knee pain for most days of the month, Morning stiffness of less than 30 minute duration, stiffness while resting the affected joint and age over 40 years. The primary outcome was self-reported pain, stiffness and physical function scores as measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), 6-minute walk distance and VAS scale measured at 0hr and 1, 2 and 4hrs respectively. Secondary outcomes included laboratory investigations and serological biomarker, i.e. Hs-CRP. A significant improvement in the clinical and biochemical endpoints along with excellent tolerability indicates that Nilin SR can be used for the long term management of Osteoarthritis. Of the 32 subjects 30 subjects completed the study. Wilcoxon paired sample test indicated WOMAC Score significantly reduced from baseline to final visit for all the three parameters; Pain (P<0.0001) Stiffness (P<0.0001) and Physical disability (P<0.0001).A significant reduction was also noted in the visual analogue scale over the course of 4 hours after ingestion of medication. A significant improvement in the 6-minute walk distance (P < 0.05) and decrease in Hs-CRP levels was observed. No adverse events were reported in the trial. Key-Words: Nilin SR, Osteoarthritis, WOMAC, VAS scale Introduction Arthritis is a common condition affecting millions of people all over the world. Osteoarthritis is one of the conditions commonly encountered among people. Osteoarthritis (OA) or degenerative joint disease is one of the oldest and most common type of arthritis. It is characterized by the breakdown of the joint's cartilage. Cartilage is the part of the joint that cushions the ends of bones. Its breakdown causes bones to rub against each other, causing pain and loss of movement. Most commonly affecting middle-aged and older people, OA can range from very mild to very severe. It affects hands and weightbearing joints such as knees, hips, feet and the back. There are many factors that can cause OA. Although age is a risk factor, research has shown that OA is not an inevitable part of aging. Obesity may lead to OA of the knees. In addition, people with joint injuries due to sports, work related activity or accidents may be at an increased risk of developing OA. Women are more commonly affected than men. * Corresponding Author E-Mail: [email protected] Fax: +91 08
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