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临床试验/CTRI/2024/03/064210
CTRI/2024/03/064210尚未招募1 期

Effect Of Rasnadi ghrita Anuvasana Basti In The Management Of Kati Graha (W.S.R. To Lumbar Spondylosis) – A Randomized Controlled Clinical Trial

Shri B M Kankanawadi Ayurveda Mahavidyalaya1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Changes in Range of Motion

研究概览

简要总结

As per the API, the incidence of low back pain (LBP) in the world is so severe that it is the 2nd most common reason why a patient visits the hospital. Although LBP has become more prominent in the case of young adults nowadays due to the current lifestyle, altered circadian rhythm along with the sedentary lifestyle and food intake: if we consider the older age group the incidence of the disease is so severe that around 85% of the population aged >40 suffer from LBA at any stage of their lives. [1]

Among these ‘LUMBARSPONDYLOSIS’ comes under the congenital LBA, which covers degenerative diseases and osteoarthritic changes in the lumbar spine. Spondylosis occurs in 6-10% of the general population and has been found to be as high as 25-60% in athletes. The prevalence of radiographic spondylosis increases with age. It is present in only a small percentage of the population in the first few decades of life, but it is common by the age of 65yr. In those with low back pain, prevalence ranges from 7-75%, depending on the diagnostic criteria.[2]

In the contemporary medical system, the treatment protocol includes medications like muscle relaxants, NSAIDs, corticosteroids, and other pain relievers, which can provide quick but temporary relief to patients.

On the other hand, for chronic cases, surgical treatments are advised, through which anatomical corrections are done for the management of the disease. For some patients, it acts like a boon by giving them permanent pain relief, but in another aspect, some patients even after the successful surgery could not recover. Even after performing such an invasive and expensive line of care, patients sometimes end their lives with a number of complications too.[3]

  As the disease also involves the older age group i.e., patients aged >60 too, the surgical approach becomes a more tough choice for the surgeon; since it has to be performed under anesthetizing the patient for >5hr, which may lead to further complications. Patients with other neurological disorders are also avoided from the surgery and have to be unwillingly dependent on the used corticosteroids and the practiced NSAIDs for pain relief. [4]

Whereas, the Ayurvedic approach to the disease is holistic. Snehana Chikista is considered to be the Best Ayurvedic remedy for dhatukshyajanya vatavyadhi, as it reduces the vitiated vata dosha which further reduces the rukshsta, kharata, parushata by providing snigdhata, shlaksanata and mruduta to the affected body organs.[5]

Snehana can be given by different procedures like- Snehaana, Abhyanga, Shirobasti, And most importantly Anuvasan basti. For the purpose of Snehana as mentioned by the Acharya Charak chatuhsneha can be used i.e. Ghrita, Taila, Vasa, And Majja . But when we consider the vata; Taila is mentioned as the best due to its vatahara properties. That is the reason why in the previously conducted studies oils like Mahanarayn taila, Balaaswagandha taila, Brihat saindhavadya taila, and Sahacharadi taila are used the previously conducted studies. [6]

Since the taken disease is a degenerative and vata vitiated disorder as per Ayurveda the cause of the disease is due to the vitiation of vata and dhatu kshyaya, which can be managed by uttarotara dhatu poshana, Acharya Charak in the context of Ghrita explains it as “YOGAVAHI” having the properties like Pitta - Anilahara.

    In the context of Anuvasan Basti; both Acharya Charak and Sushruta explained like it can be administrated daily in individuals, accustomed to daily exercise, have high digestive power, those who are Ruksha, and have Vata dominating disease in the inguinal, pelvis region, udawarta, and other Vatik disorders. In these individuals, the Sneha gets absorbed as rapidly as the water is absorbed when poured on the sand.[7]

In the experimental group “RASNADI GHRITA” is taken which has mostly vatahara drugs which would do the actions of reducing vata along with nourishing the dhatus. As a result of which the degenerative changes can be dealt with by providing uttarotara dhatu poshana.

As the drug contains drugs like Rasna which is having Vata-kapha hara actions and drugs like dashamoola which acts as an anti-inflammatory as well as having vata kapha hara actions, the trial drug may show more efficacy in treating the disease.

In the phalashrurti of the drug, A.H. “KASA CHIKISTA” adhyaya Acharya Vagbhatta clearly explains the drug can be used for Vata-predominant diseases such as pana, navana, along with basti.[8]

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

入选标准

  • Patients with signs and symptoms of kati graha.
  • VAS Scale: 3-
  • Patient X-RAY showing degenerative changes.
  • Patient fit for Basti.
  • Patient ready to give consent for the study.

排除标准

  • Patients with a recent history of Spinal Surgery Patients with established Tumors or Malignancy Patients with diagnosed T.B. of bone Pregnant and lactating mother Patients who are not fit for basti.

结局指标

主要结局

Changes in Range of Motion

时间窗: 0th day and 11th day

Changes in Oswestry Low Back Disability Questionnaires

时间窗: 0th day and 11th day

Changes in VAS Scale

时间窗: 0th day and 11th day

次要结局

  • NOT APPLICABLE(NOT APPLICABLE)

研究者

发起方
Shri B M Kankanawadi Ayurveda Mahavidyalaya
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Bagmibidbatta Ghadei

KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya

研究点 (1)

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