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临床试验/CTRI/2024/05/066642
CTRI/2024/05/066642尚未招募2/3 期

A Comparative Clinical Study to Evaluate the Efficacy of Masooradi Yoosha in Janusandhigata Vata with special reference to Knee Osteoarthritis

National Institute of Ayurveda Jaipur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月3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
60
试验地点
1
主要终点
Change in Knee injury and Osteoarthritis Outcome Score KOOS

研究概览

简要总结

Need of study:

Osteoarthritis is the second most common Rheumatological problem and it is the most frequent joint disease with a prevalence of 22% to 39% in India. Most cases of OA have no known cause and are referred to as primary OA. Primary osteoarthritis is mostly related to aging. It can present as localized, generalized, or as erosive OA. Secondary osteoarthritis is caused by another disease or condition.

OA is more common in women than men, but the prevalence increases dramatically with age (4). Nearly, 45% of women over the age of 65 years have symptoms while radio-logical evidence is found in 70% of those over 65 years.

A comprehensive evaluation of three research indicated that the Mediterranean diet is good for osteoarthritis and joint health. Such type of diets reduces inflammation, prevents weight gain, and improves health for osteoarthritis sufferers.

Aim and Objectives:

Aim:   To study the effects of Masooradi Yoosha in patients of JanuSandhigata Vata (Knee Osteoarthritis).

Objectives:  To compare the effects of Masooradi Yoosha with Abha Guggulu and Dashmool Kwath in patients of Janu Sandhigata Vata  (Knee Osteoarthrit)

Research Question:

1.What is the effect of Masooradi Yoosha in the patients of  Janusandhigata Vata  disease (Knee Osteoarthritis) ?

  1. Whether the Masooradi Yoosha has any augmenting effect when used with Ayurvedic drugs for treatment of Janu Sandhigata Vata (Knee osteoarthritis)?

Null Hypothesis: There is no effect of Masooradi Yoosha in patients of Janu Sandhigata Vata (Knee Osteoarthritis)

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Patients willing to sign consent form for the clinical trial Patients between to age group of 40-70 years irrespective of sex and socioeconomic status Clinical diagnosis of primary osteoarthritis of the knee based on clinical and radio graphic criteria ACR clinical classification criteria for osteoarthritis of the knee Patients having chronicity less than 10 years.

排除标准

  • Patients having severe joint deformities Patients suffering from paralysis whole body paralysis.
  • Patients having any type of arthropathy other than osteoarthritis such as neoplasm of spine ankylosing spondylitis Traumatic arthritis pyogenic osteomyelitis gout Patients having associated cardiac disease tuberculosis malignancy Chronicity of Sandhigata Vata of more than 10 years.

结局指标

主要结局

Change in Knee injury and Osteoarthritis Outcome Score KOOS

时间窗: at baseline and after every 2 weeks

Assessment Criteria:

时间窗: at baseline and after every 2 weeks

It will be done on the basis of changes in before treatment and after treatment KOOS score.

时间窗: at baseline and after every 2 weeks

次要结局

未报告次要终点

研究者

发起方
National Institute of Ayurveda Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ravi Kumar

National Institute of Ayurveda Jaipur Rajasthan

研究点 (1)

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