A randomized double-blind placebo controlled clinical study for the comparative evaluation of efficacy and tolerability of proteoglycan in improving knee joint health in adult subjects with mild osteoarthritis

Daehan Chemtech Co Ltd1 个研究点分布在 1 个国家目标入组 150 人开始时间: 2024年2月15日最近更新: 2024年5月10日

试验速览

阶段: Phase 3 4
状态: 已完成
发起方
入组人数: 150
试验地点: 1
主要终点: 1. Change in WOMAC total score from baseline

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

there are numerous pharmacological classes available to treat osteoarthritis, each class of drug has its unique profile of unfavorable side effects. Many medications simply treat the symptoms and not the underlying causes that allow for illness progression. Because OA is chronic in nature and therapy takes longer, safer and more potent medications are required. Despite the enormous advancements in medical research over the past century, osteoarthritis is still poorly managed. As osteoarthritis is a complex and interlinked clinical disease where there is anatomical and immunological abnormality which turns into a vicious cycle, a therapy which addresses both these abnormalities is always sought for. Medications which can halt the progression of osteoarthritis, particularly when administered in stage 0 and stage 1 osteoarthritis, are needed. Hence the quest for novel medications continues which can address osteoarthritis in a holistic approach of disease management.

Proteoglycans distributed across tissues and cellular compartments play pivotal roles in development, tissue maintenance, and disease pathogenesis. Their significance in cartilage health and osteoarthritis underscores their potential as therapeutic targets, necessitating further research for a comprehensive understanding and potential interventions.

The primary objectives of this study are to evaluate the efficacy and safety of proteoglycan in the treatment of osteoarthritis (OA) compared to a placebo. The study aims to assess various efficacy outcomes, including primary efficacy outcomes of changes in WOMAC total score, WOMAC sub-scores (pain, stiffness, physical function), pain VAS, and Lequesne Functional Index. The secondary efficacy outcomes include evaluation of change in in 20-meter walking time; change in joint space (width) narrowing; change in swelling index score; change in scores of the SF-36 questionnaire; change in TNF-alpha levels; change in COX levels; and change in C-reactive protein levels. The safety of proteoglycan and the placebo will also be closely monitored throughout the study.

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

•1.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 having mild-to-moderate pain in knee joint upon completion of 30-second Chair Stand Test or 80-meter Fast-Paced Walk Test, and otherwise no knee pain at rest.
•5.Subjects willing to refrain from taking ibuprofen, aspirin or other NSAIDs or any other pain reliever (OTC or prescription) during the entire trial.
•6.Subjects 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.
•3.Subjects having used any immunosuppressive drugs in the last 6 months (including steroids or biologics) and those with history of immune system and autoimmune disorders.
•4.Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with ambulation.
•5.Subjects with BMI less than 18.5 or more than
•6.Subjects who consumed the medicines or supplements related with joint health within 30 days before screening visit.
•7.Subjects who are not acceptable for the test by the judgment of PI.
•8.Subjects with the history of tobacco smoking.
•9.Subjects expecting the surgery during the study duration period.
•10.Female subjects, who are pregnant, breast feeding or planning to become pregnant.
•11.Subjects having known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or sensitivity to herbal products.
•12.Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol.
•13.Subjects with history of gout.
•14.Subjects who have received any corticosteroids, NSAIDs, glucosamine, and or chondroitin, within the past 90 days prior to the screening visit or any form of intra-articular treatment / injections with corticosteroids or hyaluronic acid within 90 days preceding the screening visit.
•15.Subjects with the history of congestive heart failure or any vascular conditions.
•16.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.
•17.Subjects with history of systemic lupus erythematous (SLE).
•18.Subjects with history of high alcohol intake (greeter than 2 standard drinks per day).
•19.Subjects with history of any psychiatric disorders that may impair the ability of subjects to provide written informed consent.
•20.Subjects who have participated in any other trials involving investigational or marketed products within 90 days prior to the screening visit.
•21.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 or any natural health product, (excluding vitamins).