To Assess the Efficacy of Collagen Supplement in Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Collagen Supplement is a natural ingredient that contains undenatured collagen derived from
      chicken sternum. Collagen Supplement is efficacious and safe as compared to placebo and
      efficacy is also comparable to glucosamine plus chondroitin for treatment of of knee
      Osteoarthritis
    

Detailed description: 
      Osteoarthritis (OA) is a chronic progressive degenerative disease involving thinning of
      cartilage in movable joints that leads to friction between bones creating pain, stiffness,
      and abnormal movement. It is estimated to affect more than 20% of the population over the age
      of 60 years and is considered to be a major cause of morbidity, disability, and limitations
      on the quality of life. In India, studies have reported the prevalence of 22% to 39%, with OA
      being 2nd most common rheumatological disorder. , As global life expectancy increases, the
      prevalence of OA is expected to rise further ultimately resulting in a greater burden for
      healthcare. Currently, the management has largely been palliative, focusing on the
      alleviation of symptoms.

      The principles of OA treatments primarily are to alleviate pain and stiffness and maintain
      function. The current treatment guidelines recommend a combination of physical therapy, use
      of analgesia with Acetaminophen or NSAIDs, and surgical intervention when deemed necessary.
      While medications slow the progression of OA and other inflammatory conditions, no proven
      disease-modifying agents for the treatment of knee OA currently exists. The majority of
      individuals are successfully managed with a combination of the aforementioned treatments, but
      there is still a significant group of patients in whom these treatments do not provide
      adequate relief. Furthermore, there remains a lack of treatments that have demonstrated
      effectiveness in stopping or reversing the degenerative process. , Besides, there are
      considerable side effects associated with the use of these drugs. As a result, OA sufferers
      have turned to natural nutraceuticals to ease their pain and discomfort.

      In recent years, several novel agents have emerged as potential treatment alternatives to
      improve pain, stiffness, and function with the possibility of altering disease progression.
      These products are commonly used because they are well tolerated and considered safe. Among
      the OA patients, glucosamine and chondroitin are most commonly used and have shown to
      considerably reduce the pain associated with arthritis. From the nutraceutical point of view,
      there is a growing interest in Collagen Supplement as a solution for the treatment of OA. The
      Collagen Supplement has been studied extensively in both animals as well as human clinical
      studies. , Among animal studies, a study in the rat model of OA reported several benefits
      after treatment, suggesting its potential for the prevention of worsening of articular
      cartilage damage. In another study, porcine Collagen Supplement administration demonstrated a
      significant reduction of pain intensity. Also, a lower dose regimen showed meaningful pain
      reduction indicating its protective effect on the cartilage. Furthermore, several studies
      have evaluated the efficacy and safety of Collagen Supplement in individuals suffering from
      chronic OA. Crowley and colleagues showed that supplementation of Collagen Supplement for
      three months is more efficacious as compared to the combination of glucosamine plus
      chondroitin. In another study, 6-month administration of the Collagen Supplement
      significantly reduced pain, stiffness, and physical functioning as compared to glucosamine
      hydrochloride plus chondroitin sulfate group of participants with knee OA.

      Based on the available evidence it is clear that Collagen Supplement is effective in
      improving joint discomfort associated with OA. Moreover, collagen products are also
      recognized as safe components of pharmaceutical and foods by the US Food and Drugs
      Administration Center for Food Safety and Nutrition. Hence, considering its symptomatic
      benefits, the structural effect on the cartilage and its important role in bone structure,
      Collagen Supplement is thought to be a viable alternative for OA patients. , Therefore, the
      present study aimed to evaluate the safety and efficacy of an collagen supplementation in
      participants suffering from knee OA. Study volunteers will be supplemented with Collagen
      Supplement, an collagen product for 12 weeks and assessed as per study designated efficacy
      and safety variables. Also, the efficacy and efficacy of Collagen Supplement will be compared
      with Glucosamine HCL plus chondroitin sulfate and placebo as per the set study intervals.
    

Intervention name(s): Collagen Supplement; Glucosamine chondroitin; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Three capsules post-breakfast Three capsules post-dinner; Three capsules post-breakfast Three capsules post-dinner; Three capsules post-breakfast Three capsules post-dinner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other