CTRI/2015/02/005489已完成未知
A Single Center Open label, Randomized Controlled Pilot Clinical Study to Assess and Compare the Efficacy and Tolerability of a combination of Ostikot oral tablets (three 1 g tablets twice daily) and Rhukot Plus cream external application v/s Ostikot oral tablets (three 1 g tablets twice daily) and Rhukot Liniment external application v/s Ostikot tablet (three 1 g tablets twice daily) alone in Subjects with Osteo Arthritis of Knee over a period of 12 weeks
Clinfound Clinical Research Services PvtLtd0 个研究点目标入组 75 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
- 75
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.Diagnosed with idiopathic KOA according to the clinical guidelines of the American College of Rheumatology. The guidelines include patients currently experiencing pain in one or both knees with at least 3 of the following 6 conditions: 1) aged 50 to 70 years, 2) morning stiffness within 30 minutes of waking, 3) crepitus, 4) bony tenderness, 5) bony enlargement, and 6) no palpable warmth.
- •2.VAS score during the most painful knee movement between 40-70 mm
- •3.Lequesneâ??s functional index score between 6-10 points
- •4.Patients ready to give written informed consent and willing to comply the study protocol
排除标准
- •1.Inflammatory diseases, including rheumatoid arthritis
- •3.Traumatic injury that might be related to the current knee pain
- •4.Autoimmune disease
- •5.Uncontrolled hypertension
- •6.Diabetes mellitus requiring insulin injection
- •7.Life-threatening cardiovascular or neurological events within the past year
- •8.Pregnant and lactating women
- •9.Chronic respiratory disease
- •10.Hemorrhagic disorder
- •11.Alcohol or drug addiction
- •12.Active infectious disease, including tuberculosis
- •13.Significant knee joint deformity
- •14.Knee replacement surgery for the affected knee
- •15.Knee arthroscopy within the past 2 years
- •16.Steroid injection in the knee joints within the past 3 months
- •17.Viscosupplement injections in the knee joints within the past 6 months
- •18.Joint fluid injection within the past 6 months
- •19.Acupuncture, Ayurvedic Therapy, or herbal medicine within the past 4 weeks.
研究者
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