Arthritis Osteoarthritis Clinical Trial
Official title:
A Double Blind, Randomized, Parallel Group Study to Evaluate Efficacy and Safety of NGA-01 Gel Against Placebo in the Treatment of Osteoarthritis With Joint Pain
Osteoarthritis is characterized by the breakdown of cartilage in joints. As cartilage deteriorates, the bones of the joint begin to run against one another, causing stiffness and pain, which often impairs movement. Osteoarthritis also can damage ligaments, menisci, and muscles. Bone or cartilage fragments may float in the joint space, causing irritation and pain. Bone spurs, or osteophytes, may also develop, causing additional pain and potentially damaging surrounding tissues. Around the world, an estimated 10%-15% of adults over 60 have some degree of osteoarthritis. It most commonly affects the joints in the knee, hands, feet, and spine, and is also relatively common in other joints such as the shoulder and hip joints. There are two types of osteoarthritis: primary and secondary. Primary osteoarthritis is a chronic degenerative disease that is related to, but not caused by, aging. As a person ages, the water content of their cartilage decreases, thus weakening it and making it less resilient and more susceptible to degradation. There are strong indications that genetic inheritance is a factor, as up to 60% of all OA cases are thought to result from genetic factors. The main symptoms are pain, loss of ability, and "joint stiffness after exercise or use." These symptoms are often aggravated by activity or rigorous exercise and relieved during rest, though the disease may eventually progress to the point where the patient even feels pain when resting, and some people report pain so intense that it wakes them up when they are sleeping. Osteoarthritis, at present, cannot be cured, and will likely get worse over time, but the symptoms can be controlled. Treatments vary widely, from alternative medicine, to lifestyle changes such as exercise and diet, to physical aids such as canes or braces, to medications such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDS), corticosteroids, and more. Osteoarthritis is the most common joint disease of human. Among the elderly knee osteoarthritis is leading cause of chronic disability in developed countries. Some people in India are unable to walk independently from bed and bath-room because of Osteoarthritis of the knee or hip joint. Osteoarthritis (OA) also known as degenerative arthritis or degenerative joint disease, is a group of mechanical abnormalities involving degradation of joints, including articular cartilage and subchondral bone. Symptoms may include joint pain, tenderness, stiffness, locking, and sometimes an effusion. A variety of causes viz. hereditary, developmental, metabolic, and mechanical may initiate processes leading to loss of cartilage. When bone surfaces are not well protected by cartilage, bone may get exposed and damaged. As a result of decreased movement secondary to pain, atrophy of regional muscles, and ligaments may become more lax. The goal of treatment is to reduce or eliminate the signs and symptoms of Osteoarthritis. Mild to moderate disease is often treated with topical therapies. Sponsor has developed the NGA-01Gel containing the fixed dose combination of alcohol and water mixture, with active herbal ingredients, without preservatives and dyes. The Gel is easy to apply, and the cosmetic appearance is that of a white, milky gel, easily-spreadable that absorbs completely into the skin a few minutes after application and it is expected that the Gel will differentiate from marketed formulations by patient preference for the gel and gel.
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