CTRI/2021/06/033930尚未招募3 期
A prospective, randomized, observer blind, comparative, parallel, 2-arm study to evaluate the efficacy and safety of a Myostaal liniment application as addon therapy for muscle strengthening in participant suffering from osteoarthritis of knee
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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
- •Diagnosed case of Idiopathic knee osteoarthritis for minimum 1month and maximum 5 years according to clinical guidelines of
- •American college of Rheumatology. The guidelines include patient
- •currently experiencing pain in one or both the knees with at least 3
- •out of the following 6 features:
- •- Age 40 ââ?¬â?? 70 years
- •- Morning stiffness within 30 minutes of walking
- •- Crepitus
- •- Bony tenderness
- •- Bony enlargement
- •- No palpable warmth
- •3. Participant 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.
- •4.Participants willing to give written informed consent.
- •5. Participants willing to follow up.
排除标准
- •1. Participants with secondary arthritis related to systemic inflammatory
- •arthritis (including rheumatoid arthritis, psoriatic arthritis, postinfectious arthritis and metabolic arthritis, traumatic arthritis or
- •surgical joint replacement)
- •2. Participants on corticosteroid use: (a) oral corticosteroid within the
- •previous 14 days, or (b) intramuscular corticosteroid within 30 days,
- •or (c) intra-articular corticosteroid into the study knee within 90 days, or (d) intra-articular corticosteroid into any other joint within 30 days, or (e) topical corticosteroid at the site of application within 14 days; Or patient requiring systemic corticosteroids during the course of study.
- •3. Participants on NSAIDS use will be excluded.
- •4. Participants who has undergone or who is planning to undergo surgery in next 3 months will be excluded from the study
- •5. Participants who has underwent knee replacement surgery for the
- •affected knee and who have undergone a knee arthroscopy within
- •past 2 years. Also, Patient with intra-articular visco supplementation
- •(e.g., SynviscR) in the affected knee joint in the preceding 6 months
- •6. Participants with on-going use of medication including oral muscle
- •relaxants, or low-dose antidepressant for any chronic pain
- •7. Participants with auto-immune disease, uncontrolled hypertension,
- •Diabetes mellitus requiring insulin injections and chronic severe
- •respiratory disease.
- •8. Participants with history of clinically-active renal, hepatic or peptic ulcer disease
- •9. History of life threatening cardiovascular and /or neurological event in the past one year.
- •10. Participants with history of alcohol or drug abuse, bleeding disorder
- •11. Participants having any severe active infectious disease requiring
- •hospitalization.
- •12. Pregnancy or lactation.
- •13. Participants who has taken any herbal medication in the past 4 weeks.
- •14. Participants with history of severe allergy or anaphylactic reaction.
- •15. Participants participating in another investigational drug trial in the
- •previous 30 days.
- •16. Participants who cannot give valid consent such as mentally retarded, unconscious patients and psychiatric illness
- •17. Known history of positive screening result for hepatitis B and/or
- •Hepatitis C virus.
- •18. History of HIV or any immune deficient conditions
研究者
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