跳至主要内容
临床试验/CTRI/2024/01/061535
CTRI/2024/01/061535尚未招募2/3 期

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

Central Council for Research in Ayurvedic Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月20日最近更新:

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 blood‐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

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Arun Kumar

Central Council for Research in Ayurvedic Sciences (CCRAS)

研究点 (1)

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