CTRI/2024/07/070176尚未招募不适用
A Randomized, Double-blind, Placebo Controlled Trial to evaluate the efficacy of JUVECOL K in improving knee joint health.
Naturetech co Ltd2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年8月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Change from baseline to the end of the study period in total WOMAC score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of proteoglycan (JUVECOL K) in improving Knee joint health. Enrolled subjects will receive either JUVECOL K or Placebo for 16 weeks. Study consists of 7 visits (including screening visit). Subjects shall be Randomised to either Juvecol K or Placebo on Day 1 and subsequently subjects shall be informed to visit the site for the follow up visits (i.e. Week 2, Week 4, Week 8, Week 12 and Week 16).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and female subjects aged between 40-70 years with body mass index (BMI) of 18.
- •29.9 kg/m2 2.Subjects with radio graphic evidence by Kellgren-Lawrence grade 1 or 2 3.One knee joint (or most painful knee joint among the two) with a VAS score of 30-70 mm 4.Subjects with sedentary lifestyle, no regular athletic or sports activities 5.Subject agrees to maintain diet tracker 6.Subject considered generally healthy as per health history and routine clinical investigations during screening. 7.Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, or double-barrier and have a negative pregnancy test at the screening visit 8.Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.
排除标准
- •1.Routine use of dietary supplements containing proteoglycans,hyaluronic acid, N-acetyl glucosamine, glucosamine,chondroitin sulfate, collagen peptides, Curcumin, Boswellia or any other constituents of the test supplement within 3 months prior to enrolment 2.Subjects with any possible signs/ indications/ history of arthritis, joint disorders including dislocations and quadriceps tendons tear 3.History of underlying inflammatory arthropathy or Gout or severe RA or OA 4.Clinical history of bone or cartilage disorders including fracture and distortion within one year prior to enrolment 5.Have taken any Intra-articular or Oral corticosteroids,indomethacin, glucosamine + chondroitin, within 3 monthsprior to screening visit (Visit 1) or intra-articular treatment/injections with hyaluronic acid within 6 months preceding the treatment period.
- •6.Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with ambulation 7.Expectation of surgery during the study duration period.
- •8.Female subjects, who are pregnant, breast feeding or planning to become pregnant 9.Fasting blood glucose level should be greater than 125 mg/dl.
- •10.Subject having known allergy to non-steroidal antiinflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or sensitivity to investigational product or any other related products 11.Have taken acetaminophen/ paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any natural health product, (excluding vitamins), within 7 days prior to the screening visit (Visit 1) 12.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 13.Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol 14.Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent 15.History of congestive heart failure or any vascular conditions.
- •16.Subjects with HIV Positive status.
- •17.Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
- •Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism 19.History of Systemic Lupus Erythematous (SLE) 20.Subjects consuming alcohol (Greater than 5 drinks per week) and smoking greater than 5 cigarettes per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.).
- •21.Any other condition that, in the opinion of the investigator, would adversely affect the subject‟s ability to complete the study or its measures.
- •22.Subjects who are participated or currently participating in another clinical trial within 30 days prior to screening.
结局指标
主要结局
Change from baseline to the end of the study period in total WOMAC score
时间窗: Day 1 (Baseline), Week 2, Week 4,Week 8, Week 12 & Week 16
次要结局
- Change from baseline to the end of the study period in Visual Analogue Scale (VAS)(Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16)
- Change from baseline to the end of the study period in total in WOMAC subscales (pain, stiffness and physical function)(Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16)
- Change from baseline to the end of the study period in Timed Up and Go test (TUG)(Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16)
- Change from baseline to the end of the study period in Six-minute walk test (SMWT)(Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16)
- Change from baseline to the end of the study period in Knee flexion range of motion(Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16)
- Change from baseline to the end of the study period in Joint space (using Digital X-ray)(Screening & Week 16)
- Change from baseline to the end of the study period in Physician Global Assessment (PGA) and Subjective Global Assessment (SGA)(Week 2,Week 4,Week 8 ,Week 12 & Week 16)
- Change from baseline to the end of the study period in Global physical activity questionnaire (GPAQ)(Day 1 (Baseline ) ,Week 2,Week 4,Week 8 ,Week 12 & Week 16)
- Change from baseline to the end of the study period in Urinary levels of CTX II(Day 1 (Baseline ) & Week 16)
- Change from baseline to the end of the study period in Serum cytokine levels (IL-6, IL-1β, TNF-α, MMP-3 levels)(Day 1 (Baseline ) & Week 16)
- Change from baseline to the end of the study period in Serum cartilage biomarker-Cartilage Oligomeric Matrix Protein (COMP)(Day 1 (Baseline ) & Week 16)
研究者
Dr Anurag Rai MS Ortho
Lifeline Hospital and Research Centre
研究点 (2)
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