A Pilot Open-Label Single-Arm Interventional Study to Evaluate the Efficacy of Investigational Product in Early to Moderate Knee Osteoarthritis - Nil

Dr Vaidya and Mr Madhusudan0 个研究点目标入组 18 人开始时间: 2026年7月31日最近更新: 2026年8月3日

试验速览

暂无简介。

•1.Male or female participants aged between 40 and 65 years both inclusive at the time
•of screening.
•2.Participants with radiographically confirmed osteoarthritis OA of the knee classified
•as Kellgren Lawrence Grade 1 to Grade
•3.Participants having a baseline WOMAC pain subscale score of greater or equal to 30 out of 100 at Screening or Baseline indicating the presence of clinically relevant knee pain symptoms.
•4.Participants willing to comply or perform study treatments including questionnaires.
•5.Participants able to give written informed consent and willingness to participate in the
•study and comply with respective procedures.

•1.Participants with severe osteoarthritis of the knee classified as Kellgren Lawrence
•Participants with a history of prior knee surgery or those currently requiring surgical
•intervention for knee osteoarthritis.
•Participants diagnosed with rheumatoid arthritis, inflammatory arthritis, or any
•autoimmune disease that may interfere with study assessments.
•Participants with regular use of non steroidal anti inflammatory drugs NSAIDs,
•defined as use more than two times per week, within the recent period prior to
•Participants who have received intra articular IA corticosteroid injections or
•hyaluronic acid HA injections in the target knee within the last 2 months prior to
•Participants with clinically significant hepatic, renal, metabolic, or other uncontrolled
•systemic disorders that, in the opinion of the Investigator, may interfere with study
•participation or interpretation of study results.
•Participants with a known allergy or hypersensitivity to seafood or any component of the Investigational Product.
•Participants who have participated in another clinical trial or received any
•investigational product within 30 days prior to screening.

发起方

Dr Vaidya and Mr Madhusudan