CTRI/2009/091/000328已完成2 期
An exploratory, randomized, triple-blind, placebo controlled study to investigate the efficacy, safety and tolerability of E-OA-07 in Patients with Osteoarthritis of the Knee Joint
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
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 adult patients of either sex aged 20-65 years.
- •?Patients with moderate to severe Osteoarthritis of knee(s), (signal joint) which is clinically detected and/or diagnosed as per Radio logic examination and American Rheumatism Association (ARA) functional classification.
- •Note - The primary knee joint under study will be nominated as the ?signal joint? while the other affected joint(s), if any, will be termed as ?non-signal joints?.
- •?ARA functional classes II and III.
- •?Kellgren Lawrence for Knee Osteoarthritis of Grade II, Grade III.
- •?Patient?s functional assessment of overall pain score should be ≥ 70 on a 100 mm Pain-Visual analog scale.
- •?Subjects willing to maintain physical activity levels.
- •?Subjects with Modified WOMAC score for the signal joint of 60 and above
排除标准
- •?Patients of any other arthritis other than Osteoarthritis.
- •?Patients with severe trauma to the knee joint.
- •?Arthroscopy of either knee in the past year.
- •?Administration of intra-articular steroids in the past 3 month or hyaluronic acid in the last 9 months.
- •?Patients 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.
- •?Patients with DVT or pre-disposed to DVT as evidenced by a score of >0 using Wells criteria for DVT.
- •?Moderate to severe peripheral neuropathy or other neurological disorders
- •?Patients requiring immediate Surgery for knee.
- •?Pregnant / lactating women and women who are planning to get pregnant
- •?Known hypersensitivity or allergy to one or more of the herbal ingredients
- •?Recent (< 3 months) participation in a clinical trial
- •?Major chronic disease of liver, CVS or CNS
- •?A psychiatric condition, chronic alcohol or drug abuse problem as evidenced by withdrawal symptoms
- •?Subjects otherwise judged by the investigator to be inappropriate for inclusion in the study
- •?Patients unwilling to discontinue their current medication for OA.
- •?Patients with peptic ulcer disease, bleeding diathesis, coagulation disorders, on anti-coagulant therapy
- •?Patients scheduled for any surgery within 3 months of completing the study.
- •?Patients with serum cholesterol levels >280 mg% and serum triglyceride levels > 500 mg%
- •?Patients with serum uric acid levels >8.3 mg%
研究者
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