CTRI/2012/04/002564已完成2 期
Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
- •Individuals > 40 yrs, either sex
- •Diagnosed as OA of the knee of at least 6 months duration fulfilling American College of Rheumatology criteria
- •Knee pain VAS- pain after walking 1,524 cm (50 feet) in a flat surface >30 mm and <90 mm
- •Kellgren-Lawrence Radiographic Grading Scale of Osteoarthritis of the Tibiofemoral Joint Grade 1â?? 3
- •Patients who were willing to discontinue all NSAIDs or other analgesic medication taken for any condition
- •Patients who had given their written informed consent & agreed to follow the protocol voluntarily
排除标准
- •Pregnancy and Lactation
- •Anemia ( <10 g% Hb) and Bleeding disorders
- •Diabetes mellitus
- •Patients who were on steroid drug therapy
- •History of surgery of the joint involved, Tidal lavage or arthroscopy of either knee within the past 12 months
- •Hypersensitivity/ allergy to food &/ drug or leech
- •Intra-articular (IA) corticosteroid injection of either knee within a 3 month interval immediately prior to baseline screening
- •Acute medical or surgical conditions which could affect the outcome of the study such as cardiac, renal, hepatic diseases.
- •Patients who were using anti-coagulants (coumadin, heparin, aspirin >325 mg per day).
- •Patients were not willing to be randomized
- •Ongoing use of prohibited medication including NSAID, other oral analgesic, muscle relaxant, or low-dose antidepressant for any chronic pain management
- •Concomitant skin disease at the application site
- •History of alcohol or Drug abuse, excessive smoking (more than 10 cigarettes/day)
- •Established/ diagnosed neurological or psychiatric disorders
研究者
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