NGA-01 Gel for the Treatment of Osteoarthritis With Joint Pain
Condition: Arthritis Osteoarthritis
MeSH terms: Osteoarthritis; Arthralgia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    


Intervention name(s): NGA-01 gel; Placebo
Intervention type(s): Other; Other
Intervention description(s): NGA-01 is a gel formulation with mostly herbal active ingredients; A Placebo with no active ingredients
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blind, randomized, parallel group study against placebo
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: osteoarthritis; pain