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临床试验/CTRI/2019/07/020129
CTRI/2019/07/020129尚未招募2 期

COMPARITIVE CLINICAL STUDY TO EVALUATE THE EFFECTIVENESS OF JANU BASTI WITH CONVENTIONAL METHOD AND JANU AVAGAHA WITH MODIFIED INSTRUMENT IN THE MANAGEMENT OF JANUSANDHIGATA VATA

Sri DharmasthalaManjunatheshwara College of Ayurveda and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年7月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Signs and symptoms of Janusandhigata Vata (Osteoarthritis of Knee joint) will be assessed by giving suitable scoring at three intervals namely before, 4th day and 8th day i.e. after completion of treatment.

研究概览

简要总结

This study is an open label, doublearm, prospective, comparative clinical study to know the effectiveness of

A.   JanuBasti using Murchitatila taila with conventional method, 45 minutes once in aday for 7 consecutive days in 20 patients

B.    JanuAvagaha using Murchitatila taila with modified Janu Avagaha instrument for 45minutes once in a day for 7 consecutive days for 20 patients

that will be conducted in India. The primaryoutcome measures will be WOMACOsteoarthritis Index, Range of movement- Measured using Goniometer, Swelling(Sotha),tenderness will be evaluated on the basis of standard criteria of RitchieArticular Index, Crepitus, Walking velocity, pain during movement (AkuncanaPrasaraneVedana)at 8 days.

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
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Subjects diagnosed as per the criteria for Janusandhigata vata (Osteoarthritis of knee joint)
  • Persistent pain for 3 months prior to recruitment
  • Moderate‑to‑severe pain on walking
  • Either gender in age group 40 – 70 years
  • Fully ambulant, literate and willing to participate in the study.
  • Subjects of either gender, irrespective of socio-economic status.

排除标准

  • Acute knee pain
  • Secondary OA
  • Major medical or psychiatric disorders.
  • Congenital bone deformity
  • Grade 4 Joint deformity35
  • History of HIV, HbSAg, Carcinoma and Tuberculosis
  • Pregnant women.

结局指标

主要结局

Signs and symptoms of Janusandhigata Vata (Osteoarthritis of Knee joint) will be assessed by giving suitable scoring at three intervals namely before, 4th day and 8th day i.e. after completion of treatment.

时间窗: before, 4th day and 8th day i.e. after completion of treatment

The disease activity of the patient will be assessed by WOMAC Osteoarthritis Index, Range of movement- Measured using Goniometer

时间窗: before, 4th day and 8th day i.e. after completion of treatment

次要结局

  • Swelling, tenderness will be evaluated on the basis of standard criteria of Ritchie Articular Index, Crepitus, Walking velocity, pain during movement(before, 4th day and 8th day i.e. after completion of treatment)

研究者

发起方
Sri DharmasthalaManjunatheshwara College of Ayurveda and Hospital
申办方类型
Private medical college

研究点 (1)

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