Experimental and Clinical evaluation of Antiarthritic activity of an Ayurvedic formulation for the treatment of Sandhigata vata w.s.r.to Osteoarthritis.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome will be measured based on clinical outcome measures, Radiological outcome measures, Bio-chemical outcome measures, safety and tolerability outcome measures to determine the effectiveness and safety of the test drug for the treatment of Sandhigatavata (Osteoarthritis).
研究概览
简要总结
This clinical study which will take place at OPD and IPD of the IPGAE&R at SVSP Hospital, a single arm open label interventional clinical study of a Ayurvedic formulation for the treatment of Sandhigatavata (Osteoarthritis) on 60 patients for 56 days. The primary outcome will be measured based on clinical outcome measures, radiological outcome measures, bio-chemical outcome measures, safety and tolerability measures to determine the effectiveness and safety of the test drug for the treatment of Sandhigatavata (Osteoarthritis). The secondary outcome is the effects of the test drug in changing of quality of life to be assessed after completion of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient having age between 40-70 years.
- •2,Patients of both sexes, irrespective of religion, habitat, income status, occupation etc.
- •3.Patients having symptoms of pain and swelling in the knee joints.
- •4.Kellgren Lawrence (Radiological scale) of e
- •5.Patients with primary osteoarthritis-knee joints (single or both knees).
- •6.Patient willing to include themselves in the study through informed consent form.
排除标准
- •1.Patients having age bellow 40 and above 70 years.
- •2.patients suffering with disease like cardiac problem, diabetes mellitus, hepatic disorder, renal disease, malignancies, pregnant mother etc.
- •3.patients who are currently participating in any other clinical trails.
结局指标
主要结局
The primary outcome will be measured based on clinical outcome measures, Radiological outcome measures, Bio-chemical outcome measures, safety and tolerability outcome measures to determine the effectiveness and safety of the test drug for the treatment of Sandhigatavata (Osteoarthritis).
时间窗: 56 days (8 weeks)
次要结局
- In the secondary outcome the effects of the test drug changing in the quality life to be assessed after completion of the treatment.(56 days (8 weeks))