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临床试验/CTRI/2025/01/079603
CTRI/2025/01/079603尚未招募2/3 期

An open label randomized clinical study to compare efficacy of Janu Basti with Sahacharadi Taila and Kubj Prasarini Taila in the management of Janusandhigata vata w.s.r to Osteoarthritis (O.A) knee Joint

Dr. Pradeep Kumar Madhur1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月8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
100
试验地点
1
主要终点
To compare the efficacy of Janu Basti with Sahacharadi Taila and Kubj prasarini Taila in the

研究概览

简要总结

This study is a open label randomized clinical trial enrolling 100 subjects divided equally into 2 groups. Patients fulfilling the inclusion criteria will be enrolled for study. Group A will be given Sahacharadi Taila Janubasti and Group B will be given Kubj Prasrini Taila Janubasti. Both group will be given Janubasti for 7 days. The efficacy of the treatment will be evaluated on basis of various assessment criteria like Janusandhishoola (joint pain), Janusandhi shotha (Joint swelling), Aakunchana Prasarana vedana (Painful joint movements), Sandhigraha (Joint Stiffness), Sparshasahyata (tenderness), Sandhisphutana (Crepitation). The result will be assessed with regards to imrovement recorded in clinical findings. Assessment will be done by adopting proper statistical tools. The primary outcome of trial will be to evaluate efficacy of Janubasti with Sahacharadi Taila and Kubj prasarini taila and to compare both the drugs.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
35.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients having signs and symptoms of Janusandhigatavata.
  • Janusandhi shoola/joint pain b.
  • Janusandhi Shotha/joint swelling c.
  • Aakunchana prasaran Vedana/ painful joint movements.
  • Sandhigraha/ joint stiffness e.
  • Sparshasahyata/tenderness f.
  • Sandhisphutana/crepitation
  • X-Ray of Knee Joint showing degenerative changes of O.A. knee joint.

排除标准

  • Patients who are below 35 and above 70 years of age.
  • Patients with known case of diabetes, Psoriatic arthritis, Systemic Lupus Erythematous (SLE), Housemaid’s knee, Polymyalgia, Rheumatoid arthritis, Gout, Tuberculosis and Patient with trauma will be excluded.

结局指标

主要结局

To compare the efficacy of Janu Basti with Sahacharadi Taila and Kubj prasarini Taila in the

时间窗: baseline (visit 1) to end of treatment

management of Janusandhigatavata w.s.r. to Osteoarthritis (O.A.) Knee joint

时间窗: baseline (visit 1) to end of treatment

次要结局

  • 1. To evaluate the efficacy of Sahacharadi Taila in Janusandhigatavata(2. To evaluate the efficacy of Kubj prasarini Taila in Janusandhigatavata)

研究者

发起方
Dr. Pradeep Kumar Madhur
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Pradeep Kumar Madhur

Shubhdeep Ayurved Medical College and Hospital

研究点 (1)

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