CTRI/2020/11/029031已完成3 期
A prospective, randomized, comparative, parallel, 2-arm study to evaluate the efficacy and safety of a Myostaal liniment application as add on therapy for muscle strengthening in patients suffering from osteoarthritis of knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
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 case of Idiopathic knee osteoarthritis for minimum 1month and maximum 5 years according to clinical guidelines of American college of Rheumatology.
- •2.Patient having baseline knee joint pain more than 40 mm on Visual Analogue Scale (VAS) either at rest or on weight bearing activities (e.g. walking, standing, climbing staircase) during the preceding 24 hours.
- •3. Patients who have Grades 1 and 2 in radiological findings.
- •4.Patients willing to give written informed consent.
排除标准
- •1. Patient with secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, post infectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement)
- •2. Patient on corticosteroid use:
- •(a) oral corticosteroid within the previous 14 days.
- •(b) intramuscular corticosteroid within 30 days.
- •(c) intra-articular corticosteroid into the study knee within 90 days.
- •(d) intra-articular corticosteroid into any other joint within 30 days.
- •(e) topical corticosteroid at the site of application within 14 days; Or patient requiring systemic corticosteroids during the course of study.
- •3. Patient who has undergone or who is planning to undergo knee replacement surgery in next 3 months will be excluded from the study.
- •4. Patient who has underwent knee replacement surgery for the affected knee and who have undergone a knee arthroscopy within past 2 years. Patient with intra-articular visco supplementation (e.g., SynviscR) in the affected knee joint in the preceding 6 months.
- •5. Patients with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease.
- •6. Patient with history of clinically-active renal, hepatic or peptic ulcer disease.
- •7. History of life threatening cardiovascular and /or neurological event in the past one year.
- •8. Patient with history of alcohol or drug abuse, bleeding disorder.
- •9. Patient having any severe active infectious disease requiring hospitalization.
- •10. Pregnancy or lactation.
- •11. Patient known to have allergy for any of ingredients of study medicine.
研究者
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