A randomized double-blind placebo controlled clinical study for the comparative evaluation of efficacy and tolerability of chondroitin sulfate in improving knee joint health in adult subjects with mild osteoarthritis
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 to Day 30, 60 and 90.
研究概览
简要总结
Chondroitin sulfate is a natural glycosaminoglycan with a wide range of biological effects on articular tissues. It has been extensively researched for its potential in the treatment of osteoarthritis, with evidence suggesting that it may help alleviate pain and improve function in OA patients. Additionally, it has demonstrated potential as a disease-modifying agent by slowing cartilage volume loss and joint space narrowing in some studies. However, the efficacy of CS can vary depending on factors such as dosage, purity, and source, making it important to use high-quality pharmaceutical-grade CS products in clinical practice. Future research should continue to explore the mechanisms of action of CS and its potential as a therapeutic agent for osteoarthritis, with a focus on safety and product quality to ensure positive patient outcomes. The present study is designed to confirm the efficacy and safety of chondroitin sulfate on mild osteoarthritic.
The present study is designed to confirm the efficacy and safety of chondroitin sulfate on mild osteoarthritic individuals with the study title—“A randomized double-blind placebo controlled clinical study for the comparative evaluation of efficacy and tolerability of chondroitin sulfate in improving knee joint health in adult subjects with mild osteoarthritis
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.
- •KL (Kellgren-Lawrence) grade of 1 to
- •At least 30 on 100 mm visual analogue scale.
- •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.
- •Subjects willing to refrain from taking ibuprofen, aspirin or other NSAIDs or any other pain reliever (OTC or prescription) during the entire trial.
- •Subjects willing to sign the informed consent and comply with study procedure.
- •Subjects able to complete the 20-meter walk test.
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).
结局指标
主要结局
1. Change in WOMAC total score from baseline to Day 30, 60 and 90.
时间窗: Day 0,Day 30,Day 60 and Day 90
2. Change in WOMAC sub-score: pain, stiffness, physical function from baseline to Day 30, 60 and 90.
时间窗: Day 0,Day 30,Day 60 and Day 90
3. Pain VAS from baseline to Day 30, 60 and 90.
时间窗: Day 0,Day 30,Day 60 and Day 90
4. Lequesne Functional Index from baseline to Day 30, 60 and 90.
时间窗: Day 0,Day 30,Day 60 and Day 90
次要结局
- 1. Change in 20-meter walking time from baseline to Day 30, 60 & 90.(2. Change in Joint space narrowing (width) from baseline to Day 30, 60 & 90.)
研究者
Dr Manju Jayaram
Kempegowda Institute of Medical Sciences