A Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Single-Center Clinical Study To Evaluate The Safety And Efficacy Of Orally Administered Nutraceutical Product In Participants With Mild Osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
研究概览
简要总结
Introduction Osteoarthritis is a common joint disorder that causes cartilage loss, changes in the underlying bone, inflammation, and chronic pain, especially affecting the knee in adults over 50. Standard treatments such as pain medicines, physical therapy, and surgery often have limitations including side effects or inadequate relief. Specialised pro resolving mediators or SPMs are natural compounds derived from omega 3 fatty acids that help resolve inflammation and support tissue repair without affecting the immune system. Early studies suggest that SPM enriched oils may improve pain, movement, and quality of life in people with osteoarthritis, but data in the Indian population are limited.
Purpose of the Study This study aims to evaluate the safety and effectiveness of a daily 500 mg SPM enriched oil supplement in adults with mild knee osteoarthritis. The study will assess whether taking the supplement can improve joint pain, stiffness, physical function, and overall quality of life while monitoring safety and tolerability. The results will provide evidence to support health claims and offer a safe, non invasive option for managing early stage osteoarthritis.
Study DesignThis is a randomized, double-blind, placebo-controlled, two-arm, single-center trial. A total of 110 adults (40–75 years) with mild knee OA (Kellgren–Lawrence Grade 1–2) will be randomized 1:1 to receive:
- Arm A (n=55): SPMs-enriched oil 500 mg once daily
- Arm B (n=55): Placebo 500 mg once daily
Treatment will continue for 12 weeks, with follow-up for another 12 weeks to monitor safety, compliance, and persistence of effects. Assessments will be at baseline, monthly visits, end of treatment, and a telephonic follow-up at Month 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 40 to 75 years inclusive at the time of screening
- •Clinically diagnosed primary knee osteoarthritis in one or both knees confirmed radiographically as Kellgren Lawrence Grade 1 or 2 in the index knee
- •VAS score for knee pain of more than or equal to 30 millimetre or more on a 100 millimetre Visual Analogue Scale (VAS) at screening
- •Body Mass Index between 20 and 29.9 kilogram per meter square inclusive
- •Osteoarthritis symptoms present for at least 3 months prior to screening
- •On stable doses of chronic medications (if any) for more than or equal to 4 weeks before screening
- •Willing and able to follow study requirements including daily product intake, completion of visit assessments, and follow-up procedures over the 6-month study period
- •Able to understand the study procedures and provide written informed consent approved by the Ethics Committee
- •Women of childbearing potential must agree to use an acceptable contraceptive method during the study and have a negative pregnancy test at screening.
排除标准
- •Inflammatory arthritis including diagnosed rheumatoid arthritis psoriatic arthritis gout or any other autoimmune or inflammatory joint disease
- •Secondary osteoarthritis due to trauma congenital abnormalities metabolic disorders or endocrine disorders
- •Severe osteoarthritis defined as Kellgren Lawrence Grade 3 or 4 in the index knee
- •History of knee joint replacement or planned knee surgery during the study period 5.Intra articular injection of corticosteroids hyaluronic acid or platelet rich plasma in the index knee within 3 months prior to screening
- •Prohibited medication use including -Use of non steroidal anti inflammatory drugs or COX 2 inhibitors within 3 weeks prior to baseline -Use of opioid analgesics within 3 weeks prior to baseline -Use of joint specific supplements such as glucosamine chondroitin or omega 3 supplements initiated within 4 weeks prior to screening
- •Known allergy or hypersensitivity to seafood fish oil or any component of the investigational product or placebo
- •Body Mass Index 30 kilogram per meter square or above at screening
- •Significant medical conditions including -Clinically relevant hepatic or renal dysfunction(example: ALT/AST greater than 2.0 multiplied ULN: eGFR less than 50 mL per minute per 1.73 meter square) -Uncontrolled hypertension(example: BP more than 160/100 mmHg) -History of myocardial infarction stroke or unstable cardiovascular disease within the last 6 months -Active peptic ulcer disease or gastrointestinal bleeding
- •Cognitive impairment or psychiatric disorders that could interfere with study participation or informed consent
- •Substance use history -History of alcohol or drug abuse in the past 12 months.
- •Heavy smoking defined as more than 20 cigarettes per day or equivalent tobacco consumption
- •Participation in another interventional clinical trial within 3 months prior to screening
- •Women who are pregnant lactating or planning pregnancy during the study period
- •Any other condition that in the investigator opinion could compromise participant safety study conduct or data integrity.
研究者
Dr Bharadwaj G K
Currex Hospital