NCT04470336

To Assess the Efficacy of Collagen Supplement in Osteoarthritis

A Double-blind, Placebo-controlled, Randomized, Parallel Study to Assess the Efficacy of Collagen Supplement in Osteoarthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
OTHER	Collagen Supplement	Three capsules post-breakfast Three capsules post-dinner
OTHER	Glucosamine chondroitin	Three capsules post-breakfast Three capsules post-dinner
OTHER	Placebo	Three capsules post-breakfast Three capsules post-dinner

Timeline

• Start date: 2020-07-09
• Primary completion: 2021-02-24
• Completion: 2021-04-12
• First posted: 2020-07-14
• Last updated: 2021-04-30

Locations

5 sites across 1 country: India