Randomized, double blind, placebo controlled clinical study to assess the efficacy & safety of Re-Cart capsules in subjects with knee osteoarthritis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 3.Symptom grading on 4-point Linkert scale for joint swelling, tenderness, warmth at baseline to end of the study.
研究概览
简要总结
Randomized, double blind, placebo controlled clinical study to assess the efficacy & safety of Re-Cart capsules in subjects with knee osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults (age 18 to 60) both sex with BMI not more than 30.00 kg/m2; 2.Confirmed Diagnosis of knee osteoarthritis as per ACR (American College of Rheumatology) 3.Patient reported pain score between 5-15 (Both inclusive) on WOMAC-A scale at screening.
排除标准
- •1.Conditions such as rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, pseudo gout or pain due to malignant disease as per clinical judgement or available evidences and laboratory findings with patients; 2.BMI >30 kg/m2; 3.Indication of surgery for OA knee; 4.Arthroscopy of either knee in the past year; 5.Use of systemic steroids or herbal medication for OA within 4 weeks of screening; 6.Use of Vit.
- •D3 injections, Glucosamine sulphate, Chondroitin sulphate, Diacerin, Alendronate in the past 3 months; 7.Administration of intra-articular steroids in the past 3 month or hyaluronic acid in the last 9 months; 8.History of osteoporotic/ osteoarthritic fractures within the past 6 months; 9.Pregnant or lactating women or women with inadequate contraceptive measures; 10.Evidence or clinical suspicion of any major medical conditions (E.g. uncontrolled diabetes mellitus, uncontrolled hypertension, cardiovascular disease, thyroid, hepatic, renal dysfunction); 11.Presence of any clinically significant laboratory anomaly; 12.Moderate to severe peripheral neuropathy or other neurological disorders; 13.Alcohol abuse, medication or drug dependence.
结局指标
主要结局
3.Symptom grading on 4-point Linkert scale for joint swelling, tenderness, warmth at baseline to end of the study.
时间窗: Screening, Baseline, Day 30, Day 60 and Day 90
1.WOMAC A, B and C subscale scores for pain, stiffness and physical disability at baseline, day 30, 60 and end of the study.
时间窗: Screening, Baseline, Day 30, Day 60 and Day 90
WOMAC-A is assessed by a Linkert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain, WOMAC- B for levels of stiffness and |WOMAC-C for levels of physical disability.
时间窗: Screening, Baseline, Day 30, Day 60 and Day 90
2.Knee Range of Motion (ROM) results measured by goniometer at baseline and end of the study.
时间窗: Screening, Baseline, Day 30, Day 60 and Day 90
次要结局
- 1.Kellgren Lawrence radiological severity of Grade at baseline and end of the study.(2.CRP and Il-6 levels at baseline and end of the study.)