Treatment of Arthritis Clinical Trial
Official title:
Comparative Clinical Efficacy and Safety of Coded Polyherbal Medicine Arthitec 1 and Arthitec 2 With Allopathic Medicine for the Management of Arthritis
This study aimed to develop two poly herbal capsule formulations for arthritis through granulation and conduction of their clinical trial in order to achieve quality, efficacy and safety. Arthritis is a chronic disease of unknown cause. An inflammatory disease of the synovium, it results in pain, stiffness, swelling, deformity and, eventually, loss of function in the joints. Despite early detection, current treatment medications are limited in their efficacy and are frequently toxic. Many patients look for complementary and alternative medicine (CAM) options in coping with this debilitating disease. Research has indicated that people suffering from chronic pain, as in arthritis, and those dissatisfied with current treatment are very likely to seek alternative treatments, and an estimated 60-90% of persons with arthritis use complementary and alternative medicines. Among the most widely used treatments are chiropractic and herbal therapies. This growing interest in alternative medical practices clearly indicates the need for more thorough investigation into the safety and efficacy of herbal medicine. Thousand years of traditional use can provide us with valuable guidelines to the selection, preparation and application of herbal formulation. To be accepted as viable alternative to modern medicine, the same vigorous method of scientific and clinical validation must be applied to prove the safety and effectiveness of a therapeutical product.
Although there are more than 100 different kinds of arthritis, the three most common are
gout, osteoarthritis (OA) and rheumatoid arthritis (RA).Gout occurs in response to the
presence of monosodium urate (MSU) crystals in joints, bones and soft tissues, and is usually
treated by non-steroidal anti-inflammatory drugs (NSAIDs), oral or intravenous colchicines,
and oral, intravenous or intraarticular glucocorticoids. All these drugs can abort acute
attacks, but they also may have severe side effects. OA results from articular cartilage
failure induced by a combination of genetic, metabolic, biochemical and biomechanical
factors. OA is normally treated with analgesics such as acetaminophen and opioids, NSAIDs,
and intraarticular therapies such as glucocorticoids and hyaluronans.
In RA, 75% of the sufferers are women, suggesting the importance of hormones in the etiology
of the disease. Smoking and stress are also thought to contribute to this disease, which is
characterized by joint stiffness and swelling, often in a symmetrical pattern on both sides
of the body. The goals of management of patients with RA are to control pain and swelling,
delay disease progression, minimize disability, and improve quality of life. For pain control
and swelling, treatment includes analgesics such as acetaminophen and opioids, NSAIDs, and
intra-articular therapies such as glucocorticoids. In addition, disease modifying
anti-rheumatic drugs (DMARDs) are used to modify the clinical and radiological course of RA.
Examples include methotrexate (MTX), sulfasalazine, leflunomide, hydroxychloroquine and newer
therapies such as anti-tumor necrosis factor (TNF)-a therapy (etanercept, infliximab and
adalimumab), anti-CD20 therapy (rituximab) and abatacept However, all of these agents are
associated with numerous side effects Promising evidence has been found for the effective use
of some herbal preparations in the treatment of arthritis. Furthermore, evidence suggesting
that some herbal preparations reduce consumption of non‐steroidal anti‐inflammatory drugs. It
has been evident that some herbal preparations (Tripterygium wilfordii Hook F) monotherapy is
not inferior then methotrexate and in combination with methotrexate showed better result than
alone. In addition, adverse effect associated with trials of herbal preparation for arthritis
is not only fewer but also minor. Evidence-based complementary and alternative medicine
treatments are remarkably successful in addressing not only chronic but acute health issues
as well. It is strongly perceived that different complementary and alternative medicine
treatments exerts their healing potential by influencing immune system.
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