CTRI/2014/01/004337已完成未知
An Open Labeled Clinical Study to Evaluate the Safety and Efficacy of LI15903F1 in Reducing Symptoms of Knee Osteoarthritis
aila Nutraceuticals0 个研究点目标入组 25 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
- 25
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
- •Ambulatory, male and female subjects 40 â?? 75 years of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2
- •Unilateral or bilateral OA of the knee for greater than 3 months (ACR criteria)
- •Subjects with radio graphic evidence by Kellgren - Lawrence grade 1 to grade 2
- •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
- •VAS score during the most painful knee movement between 40-70 mm
- •Subjects having mild-to-moderate pain not adequately or completely controlled with anti-inflammatory drugs
- •Results of screening are within normal range or considered not clinically significant by the Principal Investigator
- •Be willing to refrain from taking Ibuprofen, Aspirin or other NSAIDs (other than Acetaminophen / Paracetamol as rescue medication) or any other pain reliever (OTC or prescription) during the entire trial.
- •Willing to sign the informed consent and comply with study procedure
排除标准
- •Female subjects, who are pregnant, breast feeding or planning to become pregnant.
- •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
- •History of underlying inflammatory arthropathy or severe RA or OA (VAS score greater than 70)
- •Subjects scheduled for any surgery within 3 months of completing the study
- •Recent injury in the area affected by OA of the knee (past 4 months)
- •History of Gout
- •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 within 6 months preceding the treatment period.
- •History of congestive heart failure
- •Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies
- •History of Systemic Lupus Erythematous (SLE)
- •High alcohol intake (2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)
- •History of psychiatric disorder that may impair the ability of subjects to provide written informed consent
- •Participation in any other trials involving investigational or marketed products within 30days prior to the Screening Visit
- •Have taken Acetaminophen / Paracetamol, Ibuprofen, Aspirin or other NSAIDs or any other pain reliever (OTC or prescription) or any natural health product, (excluding vitamins), within 7 days prior to the Screening Visit(Visit 1)
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