CTRI/2023/05/053146尚未招募2/3 期
A randomized comparative trial to assess the effect of Agnikarma done by different Lauha Shalaka in Janusandhigatavata (knee osteoarthritis)
Dr Farista1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年1月6日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Evaluation of effective Lauha Shalaka for Agnikarma in Janu Sandhigatavata. on the basis of Change in WOMAC scale.
研究概览
简要总结
Participants attending the OPD and IPD of the NIA hospital and satisfying the selection criteria will
be selected. All the participants who voluntarily agree to participate and provide informed written
consent for participation will be recruited in the study.
Total 75 participants will be selected after detailed examination and divided in 5 group of 15 patients
each as per study protocol. All Procedures will be executed done under aseptic condition . Patient will be taken for follow-up
initially 7 th day ,14th day , 21 st day ,follow up for next 4 weeks ( 2 weekly interval ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 50.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex with the age group between 50yrs.
- •â€¢ Clinical features of Sandhigatavata for more than 6 months with the X-ray findings of Grade 1st, 2nd and 3rd on the basis of Kellgren-Lawrence score.
排除标准
- •Above 70 years of age • Below 50 years age of patients.
- •â€¢ Rheumatoid arthritis, Gouty arthritis.
- •â€¢ Patients with local infection or skin diseases, on the proposed site of Agnikarma.
- •â€¢ Patient suffering from diabetes mellitus, cardiovascular diseases, HIV, hepatitis, endocrinal disorders, hypertension, infective arthritis, malignancy.
- •â€¢ Pregnant and lactating mother.
- •â€¢ Contraindications for Agnikarma.
结局指标
主要结局
Evaluation of effective Lauha Shalaka for Agnikarma in Janu Sandhigatavata. on the basis of Change in WOMAC scale.
时间窗: At baseline, 1st week, 2nd week, 3rd week
次要结局
- To validate the effect of Agnikarma in the management of Janu Sandhigatavata.(At 5th week)
研究者
研究点 (1)
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