CTRI/2017/12/010838已完成未知
A Double Blind, Prospective, MultiCentric, Randomised, Three Arm, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Polyherbal Formulation INDR/OA/001 in comparison with Placebo and a Formulation containing Glucosamine and Chondroitin Sulphate in the Treatment of OsteoArthritis in Adult Subjects.
AVN Ayurveda Formulation Private 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 60 years of age with confirmed diagnosis or known history of osteoarthritis with moderately active lifestyle (both sexes and ages inclusive)
- •2.Subject with Grade II or III of Kellergen Lawrence (KL) Grade.
- •3.Subject with pain (Pain Scale score is 4) on walking in one or both knees 24 hours prior to screening.
- •4.Subjects with BMI is less than or equal to 30 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 herbal 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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