“A prospective community based study for the evaluation of YograjGuggulu, Ashwagandha Churna and Narayana Taila in Osteoarthritis Knee (JanugatSandhivata)â€
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 10
- 主要终点
- i.Changes in Western Ontario and McMaster University osteoarthritis (WOMAC) total score [Time frame: from base line to end of 4th, 8th, 12th week, 16th week] Indian WOMAC (Modified –CRD Pune Version)
研究概览
简要总结
**Study title:**A prospective community based study for the evaluation of Yograj Guggulu, Ashwagandha Churna and Narayan Taila in Osteoarthritis Knee (JanugatSandhivata)
This is a research study being conducted under the Ayurveda Mobile Health Care Programme (AMHCP) by Central Council for Research in Ayurvedic Sciences (CCRAS), an autonomous organization under Ministry of AYUSH, Government of India, involving administration of Yograj Guggulu, Ashwagandha Churna and Narayan Taila with an objective to assess the role of the intervention in Osteoarthritis Knee (JanugatSandhivata).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria: 1.Participant of any gender in the age group 40-65 yrs of Scheduled Caste community 2.Participant who are willing to provide written consent.
- •3.Participant of primary Osteoarthritis knee (Unilateral/ bilateral) as per any one of the following three ACR diagnostic criteria
- •Using history and physical examination Pain in the Knee and 3 of the following: i.Over 50 years of age.
- •ii.< 30 minutes of morning stiffness iii.Crepitus on active motion iv.Bony tenderness v.Bony enlargement vi.No palpable warmth
- •Using radiographic findings: (if available) Pain in the Knee and 1 of the following: i.Over 50 years of age.
- •ii.< 30 minutes of morning stiffness iii.Crepitus on active motionand osteophytes.
- •Using history, physical examination and laboratory findings: (if available) Pain in the Knee and 5 of the following: i.Over 50 years of age.
- •ii.< 30 minutes of morning stiffness iii.Crepitus on active motion iv.Bony tenderness v.Bony enlargement vi.No palpable warmth of synovium vii.ESR < 40mm/hour viii.Rheumatoid Factor (RF) < 1:40 ix.Synovial fluid (SF) signs of osteoarthritis.
排除标准
- •i.Diagnosed cases of Rheumatoid arthritis or other type of inflammatory arthritis or patients who report to have been under anti-arthritic medication for RA or inflammatory arthritis.
- •ii.Participant prescribed Joint replacement surgery.
- •iii.Participant with history of trauma to the afflicted joint.
- •iv.Use of ambulatory aids such as wheel chair, walker etc v.Someone who has BMI≥32kg/m² at the screening visit.
- •vi.Co-morbid conditions such as past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •vii.Known case of Renal/ Hepatic / Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease, Uncontrolled DM or HTN.
- •viii.Pregnant women/ women who are planning for conception and lactating women ix.Patient taking participation in any other clinical trial.
- •x.Any other condition which the P.I. thinks may jeopardize the study.
结局指标
主要结局
i.Changes in Western Ontario and McMaster University osteoarthritis (WOMAC) total score [Time frame: from base line to end of 4th, 8th, 12th week, 16th week] Indian WOMAC (Modified –CRD Pune Version)
时间窗: i.Changes in Western Ontario and McMaster University osteoarthritis (WOMAC) total score [Time frame: from base line to end of 4th, 8th, 12th week, 16th week] Indian WOMAC (Modified –CRD Pune Version)
次要结局
- i.Change in the Visual Analogue Scale (VAS) for pain(ii.Assessment of changes in Ayurvedic disease specific symptoms of sandhivata)