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临床试验/CTRI/2025/03/082002
CTRI/2025/03/082002尚未招募不适用

A clinical trial to compare the effect of vasayuktha vachadi upanaha with mahanarayana taila yuktha vachadi upanaha in the management of primary OA knee

Dr Amrutha Mohanan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
TUG T test

研究概览

简要总结

Osteoarthritis(OA) is by far the most common form of arthritis which shows a strong association with

ageing & is a major cause of pain & disability in the elderly. It is the most frequent joint disease

with a prevalance of 22% to 39% in India. As per Ayurveda OA knee is considered as Janu

Sandhigata vata which is a type of VataVyadhi affecting the Sandhi. Pathologically,it maybe defined

as a condition of synovial joints characterized by focal loss of articular hyaline cartilage with

proliferation of new bone& remodelling of joint contour. Swedana is the prime modality of treatment

for many diseases especially Vata &Kapha predominant diseases. Sthambhagna, Gouravaghna

,Sheetaghna are the main properties of Swedana. . Charaka has included Swedana karma under

Shadupakrama,where it is described as a principal method of treatment. Since degenerative OA can be

considered as Kevala Vatika associated with majja dhatu kshaya&shleshaka kapha kshaya ;Upanaha

which is an ideal tropical treatment in which Swedana is done by Bandhana is also indicated for

kevala vatika Condition.Even though it is effective with medium like taila ,for reducing pain only,by

looking forward for Majja dhatu &shleshaka kaphakshaya in Janusandhigata vata we can think about

usage of Vasa as a medium of application in Upanaha which is not studied yet properly.Hence,the

objectives of this study is to find the effect of Vachadi Upanaha with vasa in comparison with taila in

the Management of OA Knee. Vasa ,one among the important Chatusneha dravya ,which is not

commonly used as that of Taila &Ghritha is used here to compare Efficacy. The study is comparative

clinical trial with control group.Cases will be diagnosed based on the Kellagran-Lawrence radiological

scale of OA knee&also data is collected via observation,clinical case performa and xray. Participants

irrespective of sex, aged 45 – 65 years registered in OPD and IPD of Government Ayurveda college

Panchakarma Hospital, Thiruvananthapuram satisfying the inclusion criteria will be subjected to

consecutive sampling and the total of 30 participants will be selected for the study,where the trial

group will receive vachadi Upanaha with vasa and control group will receive the same with

Mahanarayana Taila.

Key words:Osteoarthritis, Upanaha,Vasa. Mahanarayana taila

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
45.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Participants irrespective of gender among age group 45-65years of age 2.Radiological changes as per grade 1 to 3 of kellgren-Lawrence radiological scale 3.Participants willing to give informed consent.

排除标准

  • 1 Known case of RA and other type of arthritis.
  • 2 Congenital abnormalities 3 Participants with h/o any trauma fractured joint surgical diagnostic intervention with reference to the affected joint 4 Participants with uncontrolled diabetes mellitus FBS 160mg/dl and Hypertension,160/100mmhg severe liver and renal disorder Malignancy 5 Known case of dermatological disorders 6 Body mass index BMI40kg/m2.

结局指标

主要结局

TUG T test

时间窗: Intervention done for 14 days | Assessment will be done on 0th day,15th day,28th day

WOMAC osteoarthritis index

时间窗: Intervention done for 14 days | Assessment will be done on 0th day,15th day,28th day

Range of movements using goniometry

时间窗: Intervention done for 14 days | Assessment will be done on 0th day,15th day,28th day

safety by event evaluation scale

时间窗: Intervention done for 14 days | Assessment will be done on 0th day,15th day,28th day

次要结局

未报告次要终点

研究者

发起方
Dr Amrutha Mohanan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Amrutha Mohanan

Government Ayurveda College Thiruvananthapuram

研究点 (1)

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