“A prospective community based study for the evaluation of Yograj Guggulu, Ashwagandha Churna and Narayana Taila in Osteoarthritis Knee (Janugat Sandhivata)â€
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 490
- 试验地点
- 14
- 主要终点
- i.Changes in Western Ontario and McMaster University osteoarthritis (WOMAC) total score, Indian WOMAC (Modified –CRD Pune Version)
研究概览
简要总结
1. Objectives of the Study :
·Primary objective- To assess the role of Ayurvedic formulations Yograj Guggulu, Ashwagandha Churna and Narayan Taila in the subjective outcomes of Osteoarthritis Knee (Sandhigat Vata).
·Secondary objective-
i) To assess the role of the intervention in disease specific symptoms.
ii) To evaluate the tolerability of Ayurvedic formulation Yograj Guggulu, Ashwagandha Churna and Narayan Taila in the management of Osteoarthritis Knee.
2. **Study Design :**Interventional
3. **Sample Size:**490 ( i.e. 35 each centre) Total Study participating centers-14
4. **Duration of Study :**10 Month
5. **Interventions :**Yograj Guggulu, Ashwagandha Churna and Narayan Taila
6. Study initiated on -20th July 2021
7. Study Completed on -21st March 2022
8. Number of Cases Enrolled- 490
9. Number of cases Completed- 483
10. Number of Drop outs- 07
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participant of any gender in the age group 40-65 yrs of Scheduled Tribe 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.
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/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, Indian WOMAC (Modified –CRD Pune Version)
时间窗: i.At Baseline, End of 4th week, End of 8th week, End of 12th Week, and End of 16th week.
次要结局
- i.Change in the Visual Analogue Scale for pain(ii.Assessment of changes in Ayurvedic disease specific symptoms of sandhivata(sandhishula , Sandhishotha,Akunchana prasaranayoh vedana,Stambha,sandhisphutana ))