CTRI/2019/07/020058尚未招募2 期
A prospective, active-controlled, randomized, observer blind, comparative, parallel, 2-arm study to evaluate the efficacy and safety of oral Myostaal forte a polyherbal formulation in preventing acute flares in patients suffering from osteoarthritis of knee
Solumiks Herbaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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 6 months 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 â?? 70 years
- •- Morning stiffness within 30 minutes of walking
- •- Crepitus
- •- Bony tenderness
- •- Bony enlargement
- •- No palpable warmth
- •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 willing to give written informed consent.
- •4. Patients willing to follow up.
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, 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. Patient who has undergone or who is planning to undergo 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. Also, Patient with intra-articular visco supplementation (e.g., Synvisc®) in the affected knee joint in the preceding 6 months
- •5. Patient with on-going use of medication including oral muscle relaxants, or low-dose antidepressant for any chronic pain management
- •6. Patients with on-going use of glucosamine or chondroitin sulphate or used continuously for 30 days prior to the study entry
- •7. Patients with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease.
- •8. Patient with abnormal Hb/CBC values, 10% beyond the normal range will lead to exclusion of the patient from the study.
- •9. Patient with laboratory parameters of Liver function test more than 1.5 times the upper limit of normal or detected any time during the study period will lead to exclusion of the patient from the study.
- •10. Patient with Serum Creatinine more than 1.5 mg/dl, detected any time during the study period will lead to exclusion of the patient from the study
- •11. Patient with history of clinically-active renal, hepatic or peptic ulcer disease
- •12. History of life threatening cardiovascular and /or neurological event in the past one year.
- •13. Patient with history of alcohol or drug abuse, bleeding disorder
- •14. Patient having any severe active infectious disease requiring hospitalization.
- •15. Pregnancy or lactation.
- •16. Patient who has taken study drug or any herbal medication in the past 4 weeks.
- •17. Patient with history of severe allergy or anaphylactic reaction.
- •18. Patient participating in another investigational drug trial in the previous 30 days.
- •19. Patients who cannot give valid consent such as mentally retarded, unconscious patients and psychiatric illness
- •20. Known history of positive screening result for hepatitis B and/or Hepatitis C virus.
- •21. History of HIV or any immune deficient conditions
研究者
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