CTRI/2019/06/019856已完成未知
A Double Blind, Prospective, Placebo Controlled, Randomised, Three Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Collagen Peptide of Titan Biotech Limited in the Treatment of OsteoArthritis in Adult Subjects.
Titan Biotech Limited0 个研究点目标入组 72 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
- 72
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 Kellergen Lawrence (KL) Grade.
- •3.Subject with pain (VAS score >=4) on walking in one or both knees 24 hours prior to screening.
- •4.Subjects with BMI <=35 at the time of screening.
- •5.Subjects who are ambulatory, requiring but not currently receiving or not satisfied with anti-inflammatory or anti-analgesic drugs.
- •6.Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
- •7.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 to investigational product or its constituents.
- •2.Subjects with known hypersensitivity to NSAID, aspirin, COX-2 inhibitors and other analgesic medicine.
- •3.Subjects who have had hyaluronic acid injections, upto 6 months prior to enrolment.
- •4.Subjects who have had Intra-Articular Steroid, upto 3 months prior to enrolment.
- •5.Subjects with immunucompromised state complications.
- •6.Significant (requiring surgical correction) valgus or varus deformity of the knee, ligamentous laxity, or meniscal instability.
- •7.Concomitant inflammatory or any other disease/condition which may affect joints (eg, rheumatoid arthritis, metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis etc.).
- •8.History of sepsis in any joint or any clinical concern for a sub-acute infectious process in the target joint.
- •9.History of surgery in the target joint.
- •10.Planned surgery on 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/drug abuse, etc.), any medical condition that is unstable/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 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.
研究者
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