CTRI/2021/04/032912已完成未知
A Double Blind, Prospective, MultiCentric, Randomised, Active Controlled and Placebo Controlled, Five Arm, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Three Doses of Bioactive Bone Collagen Peptide as a Nutritional Therapy in the Management of Knee Joint Osteoarthritis in Adults.
itta Gelatin India Limited0 个研究点目标入组 106 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 106
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. Adults between 30 and 65 years of age with confirmed diagnosis or known history of Osteoarthritis, with moderately active lifestyle-both ages and all sexes inclusive-.
- •2. Subject with Grade II or III of Kellgren Lawrence-KL Grade.
- •3. Subject with pain on walking in one or both knees for the past 6 months. Pain Scale score greater than or equal to 4 at the time of screening.
- •4. Subjects who are ambulatory, requiring but not currently receiving or not satisfied with anti-inflammatory or anti-analgesic drugs.
- •5. Subject or LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
- •6. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
排除标准
- •1. Subjects with known hypersensitivity or vegetarians or vegans who object to consumption of animal origin investigational product.
- •2. Subjects with contraindications to MRI- pacemaker, ferromagnetic vascular clip, infusion pump, neurostimulator, cochlear implant, suspicion of metallic foreign body, claustrophobia.
- •3. Subjects with known hypersensitivity to NSAID, aspirin, COX-2 inhibitors and other analgesic medicine.
- •4. Subjects who have had hyaluronic acid injections, upto 6 months prior to enrolment.
- •5. Subjects who have had Intra-Articular Steroid, upto 3 months prior to enrolment.
- •6. Subjects with immunocompromised state complications.
- •7. Significant-requiring surgical correction-valgus or varus deformity of the knee, ligamentous laxity or meniscal instability.
- •8. Concomitant inflammatory or any other disease or condition which may affect joints-e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, gout, pseudo gout, chondrocalcinosis etc.
- •9. History of surgery in any joint or any clinical concern for a sub-acute infectious process in the target joint.
- •10. History of surgery in the target joint or planned surgery or any lower extremity joint.
- •11. Clinically significant venous or lymphatic stasis present in the leg-s-.
- •12. Clinically apparent tense effusion or inflammation at the target knee.
- •13. Any musculoskeletal condition that would impede measurement of efficacy at the target joint.
- •14. Subjects with uncontrolled diabetes, hypertension or congestive heart failure.
- •15. Any significant medical condition-e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc.-, any medical condition that is unstable or poorly controlled or other factor-e.g., planned relocation- that the Investigator felt would interfere with study evaluations and study participation.
- •16. Females who are pregnant or lactating or planning to become pregnant during the study period.
- •17. Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- •18. Subjects who in the opinion of the Investigator or the Medical Experts are not eligible for enrolment in the study.
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