Clinical study to evaluate the efficacy of oral administration of Praval bhasma, Lakshadi guggulu and local application of Dashang Lepa with pinda tail on knee joints having arthritic changes in Hemophilia patients
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in pain by V.A.S score of Hemophilia patients having arthritic changes in knee joint.
研究概览
简要总结
Hemophilia is the most common severe hereditary hemorrhagic disorder. Both Hemophilia A and B result from factor VIII and factor IX protein deficiency or dysfunction, respectively, and is characterized by prolonged and excessive bleeding after minor trauma or sometimes even spontaneously. There is Hemophilia C as well, which occurs due to deficiency of clotting factor XI but is rare. Recurrent joint bleeding (hemarthrosis) is the most frequent clinical manifestation of severe Hemophilia. Unless appropriately managed, even subclinical hemarthrosis can lead to the development of hemophilic arthropathy, a disabling condition characterized by joint remodeling, chronic pain, and a reduced quality of life, and eventually requires joint replacement. Given the lack of specific treatments to reduce bloodâ€induced synovitis, the prevention of bleeding is pivotal to the maintenance of joint health. Ayurveda has a great potential in dealing with the hemophilic arthropathy of joint caused by repeated hemarthrosis, but due to lack of awareness, study and researches, hemophilic patients are unable to take the treatment with the trust. My study will allow the hemophilic patients to use the Ayurvedic treatment with a trust to improve their quality of life, having less pain and improved confidence in them in this rare disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Male
入选标准
- •Stage 2 or 3 or 4 arthritic changes present in knee joint.
- •Pre diagnosed patient suffering from moderate to severe Hemophilia A or B from factor assay 8 or 9 or having valid registered id card from Hemophilia society or any government hospital showing factor percentage.
排除标准
- •Patient having Mild Hemophilia
- •Hemophilic patients whose Knee joints are not affected
- •Having stage 1 arthritic changes 4.
结局指标
主要结局
Improvement in pain by V.A.S score of Hemophilia patients having arthritic changes in knee joint.
时间窗: Day 1 | Day 30 | Day 45
次要结局
- -Improvement in Range of Motion ≥15 degree in affected knee joint by goniometer.(-Reduction in thickness of synovitis ≥1mm in affected knee joint by USG.)
研究者
Dr Arun Kumar
Central Council for Research in Ayurvedic Sciences (CCRAS)
