A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Boswellia Serrata for the treatment of Knee Osteoarthritis in Male and Female Volunteers.

Ingex Botanicals Private Limited1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2025年3月13日最近更新: 2025年9月22日

试验速览

阶段: Phase 3 4
状态: 已完成
发起方
入组人数: 100
试验地点: 1
主要终点: Primary Endpoints:

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Knee arthritis is a chronic, painful illness characterized by atrophy and bone loss cartilage, resulting in bone damage and subsequent bone increased incidence or "remodeling." These improvements gradually contribute to joint discomfort and swelling, followed by tenderness, weakness and restriction or lack of mobility [4]. In addition to the typical symptoms of joint pain, stiffness, and reduced range of motion, some individuals with KA also experience neuropathic pain (NP). NP arises from nerve sensitization and altered pain processing mechanisms, resulting in heightened pain sensations, increased sensitivity, and abnormal sensations like tingling or burning [5]. It is the clinical and pathological outcome of a sequence of disorders that leads to structural and functional non-performance of synovial joints.1 Usually, KA increases slowly, typically in the middle-aged to elderly people. The cartilage between the bones in the joint breaks down, which causes the affected bones to slowly get bigger. The joint cartilage often breaks down due to mechanical stress or biochemical changes in the body, resulting the bone underneath to fail. OA can occur in conjunction with other types of arthritis such as gout or rheumatoid arthritis. The risk of developing OA increases dramatically with age, and it is more frequent in females compared to males. Almost, 45% of females show symptoms and 70% of them have the radiological evidence [6].Osteoarthritis (OA) is a degenerative joint condition brought on by cartilage loss and is the most common form of arthritis. OA can affect any joint in the body but occurs most often in the knees. There are typically four stages of osteoarthritis. There is inter-individual variance on how long it takes for the OA to progress. It can take anywhere from several months to several years to reach an advanced stage of OA. Staging of OA and subsequent treatment plan is based on clinical symptoms, x-rays, blood tests, and other laboratory tests.[3] Osteoarthritis is typically staged using various classification systems to assess the severity of the condition. One commonly used system is the Kellgren-Lawrence grading scale, which assigns a grade from 0 to 4

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Double

入排标准

年龄范围: 40.00 Year(s) 至 75.00 Year(s)（—）
性别: All

入选标准

•Ambulatory, male and female subjects 40-75 years of age.
•2.KL (Kellgren-Lawrence) grade of 1 to
•3.At least 30 on 100 mm visual analogue scale.
•4.Subjects who had mild-to-moderate pain in knee joint upon completion of 30 sec Chair Stand Test or 80 meter Fast-Paced Walk Test, and otherwise no knee pain at rest.
•5.Subjects who were willing to refrain from taking Ibuprofen, Aspirin or other NSAIDs or any other pain reliever (OTC or prescription) during the entire trial.
•6.Subjects who were willing to sign the informed consent and comply with study procedure.

排除标准

•Subjects with any possible signs indication history of arthritis, joint disorders including dislocations and quadriceps tendons tear.
•Subjects with history of underlying inflammatory arthropathy or severe RA or OA.
•Subjects who had used any immunosuppressive drugs in the last 6 months including steroids or biologics and those with history of immune system and autoimmune disorders.
•Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with ambulation.
•Subjects with BMI less than 18.5 or more than
•Subjects who consumed the medicines or supplements related with joint health within 30 days before screening visit.
•Subjects who are not acceptable for the test by the judgment of PI.
•Subjects with the history of tobacco smoking.
•Subjects who were expecting the surgery during the study duration period.
•Female subjects, who are pregnant, breast feeding or planning to become pregnant.
•Subjects who were having known allergy to non-steroidal antiinflammatory drugs NSAIDs including aspirin or has a suspected hypersensitivity, allergy or sensitivity to herbal products.
•Subjects who had any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol.
•Subjects with history of gout.
•Subjects who had taken corticosteroid, indomethacin, glucosamine chondroitin, within 90 days prior to the screening visit or intra-articular treatment injections with corticosteroid or hyaluronic acid within 90 days preceding the screening visit.
•Subjects with the history of congestive heart failure or any vascular conditions.
•Subjects with the evidence or history of clinically significant in the judgment of the Investigator hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurologic diseases, or malignancies, hypothyroidism.
•Subjects with history of systemic lupus erythematous SLE.
•Subjects with history of high alcohol intake 2 standard drinks per day.
•Subjects with history of any psychiatric disorders that may impair the ability of subjects to provide written informed consent.
•Subjects who had participated in any other trials involving investigational or marketed products within 90 days prior to the screening visit.
•Subjects who are currently or within 30 days prior to the screening visit on prescription or OTC medications pain relievers such as Acetaminophen Paracetamol, Ibuprofen, Aspirin or other NSAIDs r any natural health product, excluding vitamins.