CTRI/2024/07/070176尚未招募Unknown
A Randomized, Double-blind, Placebo Controlled Trial to evaluate the efficacy of JUVECOL K in improving knee joint health. - Nil
aturetech co Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Healthy male and female subjects aged between 40-70 years with body mass index (BMI) of 18.5 - 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.
- •18. 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 subjects 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
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