CTRI/2013/12/004266已完成未知
A Randomized, Double Blinded, Placebo Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of CurQlife 500 mg and CurQlife P 500 mg in Reducing Symptoms of Knee Osteoarthritis
aila Pharmaceuticals Pvt Ltd0 个研究点目标入组 60 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
- 60
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.Ambulatory, Male and female subjects 40 â?? 75 years of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2.
- •2.Unilateral or bilateral OA of the knee for greater than 3 months (ACR criteria)
- •3.Subjects with radio graphic evidence by Kellgren-Lawrence grade 2 to grade 3
- •4.Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy
- •5.VAS score during the most painful knee movement between 40-70 mm
- •6.Subjects having mild-to-moderate pain not adequately or completely controlled with anti-inflammatory drugs
- •7.Results of screening are within normal range or considered not clinically significant by the Principal Investigator
- •8.Be willing to refrain from using ibuprofen, aspirin or other NSAIDS (other than acetaminophen/paracetamol as rescue) or any other pain reliever (OTC or prescription) and Omega 3 fatty acids during the entire trial.
- •9.Willing to sign the informed consent and comply with study procedure
排除标准
- •1.Female subjects, who are pregnant, breast feeding or planning to become pregnant.
- •2.Subject has known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication
- •3.History of underlying inflammatory arthropathy or severe RA or OA (VAS score greater than 70)
- •4.Subjects scheduled for any surgery within 3 months of completing the study
- •5.Recent injury in the area affected by OA of the knee (past 4 months)
- •6.History of Gout
- •7.History of congestive heart failure
- •8.Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies
- •9.History of Systemic Lupus Erythematosus (SLE)
- •10.High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc)
- •11.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent
- •12.Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit
- •13.Have taken any corticosteroid, indomethacin, glucosamine + chondroitin, within 3 months prior to the Treatment Period, Day 0 (Visit 1) or intra-articular treatment / injections with corticosteroid or hyaluronic acid or Omega-3 Fatty acids dietary supplements within 6 months preceding the treatment period.
研究者
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