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临床试验/CTRI/2017/08/009216
CTRI/2017/08/009216尚未招募2 期

A comparative clinical study to evaluate the effect of Ksheer bala taila in Matra basti and Janu pichu along with Aswagandha shatavari ksheer pak in the management of Janu sandhigata vata w.s.r. to osteoarthritis of knee joint

National institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年1月9日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Relief in WOMAC osteoarthritis Index

研究概览

简要总结

The trial is a open label randomized clinical trial. The primary aim of the trial is to compare the efficacy of Janu pichu (in this therapy medicated oil soaked in cotton is sustained externally on specific area of knee joint in certain amount for certain period) with the efficacy of Matra basti ( a form of oily enema) in the management of  Janusandhigatavata  w.s.r. to osteoarthritis of knee joint. Total 30 patient will be taken for trial. The patient will be randomly divided into two groups of 15 patients each. In group A Janu pichu with ksheerbala taila( oil) will be done for 10 days and oral medication of Ashwagandha Shatavari Ksheer pak will be given for 30 days in the dose of 10g twice in a day.In group B Matra basti will be done with Ksheerbala taila in the dose of 60 ml for 10 days and oral medication of Aswagandha shatavari ksheer pak will be given for 30 days in the dose of 10g twice in a day. The primary outcome will be the improvement in WOMAC osteoarthritis index.The patient will be assessed after two months  of treatment.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
30.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • (1)Patients with the clinical features of Janu-Sandhigata Vata (Osteoarthritis of knee joint).
  • (2)Patients fit for Basti and Svedana.
  • (3)Patients with radiological findings of Osteoarthritis along with clinical features.

排除标准

  • (1)Patients having developed deformity.
  • (2)Patients with severe form of systemic disorders.
  • (4)Associated with simple or compound fractures.
  • (5)Patients unfit for Basti and Svedana.

结局指标

主要结局

Relief in WOMAC osteoarthritis Index

时间窗: 2month

次要结局

  • (1)Radiological improvement in osteoarthritis((2)Improvement in clinical symptoms of osteoarthritis)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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