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临床试验/CTRI/2025/02/081304
CTRI/2025/02/081304尚未招募3 期

A Randomized Open Label Controlled Clinical Study to Evaluate the Efficacy of Ajmodadadi Vataka in the Management of Vishwachi w.s.r. to Cervical Spondylosis

Jammu Institute of Ayurveda and Research Jammu1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月7日最近更新:

试验速览

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

研究概览

简要总结

Today we are living in 21st century, a century of workaholic generation, a generation which is mostly dependent on technology and spend the most time of their day in using gadgets, mobiles, working on computers, long hour of travelling and busy work schedules of corporate world. Due to this hectic, unoriented and fast life style people are not able to follow basic physical, dietary as well as mental healthy habits. These unhealthy habits increasing degenerative disease (Dhatukshaya) of spine especially of cervical region.

Vishwachi, which is one of the Vata Nanatmaja Vatavyadhi. It affects the neck and upper extremities leading to decreased efficacy with dysfunctioning of neck & extremities with signs and symptoms like Ruka, Toda, Stambha, Karmakshaya 1and Chestapaharana of Bahu2 as explained by different Acharya’. Dalhana also opines that the condition resembles Gridhrasi which affects the lower limb, and of two types, Vataja and Vata Kaphaja3

Vishwachi affects from Bahuprustha (the back aspect of the upper limb) to Talapratayangulinam because of Vata Dosha in all the Kandra (Tendon) of the Hasta (Arm) and Bahu (upper arm or shoulder), Bahu Chestha Apaharani (dysfunction of arm and shoulder). So radiating pain and restricted movement is main symptom of Vishwachi. It means the condition in which Vata dosha gets aggravated from the posterior part of fingers and anterior part of Prakoshtha and Kandara ,which reduces the motor neuron functions of the hand ,is called Vishwachi. It occurs due to variations in Ahara and Vihara like Vataprokopa Ahara and Vihara as Rukshahara,Ativyama,Vegadharana are the causative factors for Vishwachi.4-6

Vishwachi is similar to that of Cervical Spondylosis which is degenerative condition (Dhatukshaya) of the cervical spine. Further chronic stage of this condition which leads to cervical radiculopathy.

Shamana Ausadhi is mentioned in our classical text for the management of Vishwachi. In the present Ajmodadi Vataka which is mentioned in Bhavaprakash used as Shamana Ausadhi, is taken to assess its efficacy on Vishwachi w.s.r to Cervical Spondylosis and compared with the effect of Trayodasang Guggulu. Most people with spondylotic changes of the cervical spine on radiographic imaging remain asymptomatic, with 25% of individuals under the age of 40, 50% of individuals over the age of 40, and 85% of individuals over the age of 60 showing some evidence of degenerative changes. The most frequently affected levels are C6-C7, followed by C5-C6. Symptomatic cervical spondylosis most commonly presents as neck pain. In the general population, the point prevalence of neck pain ranges from 0.4% to 41.5%, the 1-year incidence ranges from 4.8% to 79.5%, and lifetime prevalence may be as high as 86.8%. According to the Global Burden of Disease 2015, low back and neck pain remain the leading cause of years lived with disability (YLD) and the fourth leading cause of disability-adjusted life.7-9

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

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

入选标准

  • Patients with age group between 20 to 70 years.
  • Patients with either gender irrespective of caste, creed and religion.
  • Patient representing signs and symptoms of Vishwachi who are willing to participate in study.

排除标准

  • Patients having the history of systematic disease like Diabetes Mellitus, Hypertension, Tuberculosis and other chronic diseases.
  • Impaired Renal function and abnormal liver function.
  • History of major trauma causing cervical vertebra fracture, traumatic injury of cervical spine, cervical myelopathy.
  • Patient suffering from neoplastic and infective disorders.
  • Pregnant and lactating women.

结局指标

主要结局

Range of Motion of Neck

时间窗: Baseline

Lhermitte Test

时间窗: Baseline

Spurling Test

时间窗: Baseline

Subjective Parameters

时间窗: Baseline

Ruk - Pain

时间窗: Baseline

Toda - Pricking Sensation

时间窗: Baseline

Gourawa

时间窗: Baseline

Arochaka - No desire to eat

时间窗: Baseline

Spandana

时间窗: Baseline

Objective Parameters

时间窗: Baseline

次要结局

  • Objective Parameters

研究者

发起方
Jammu Institute of Ayurveda and Research Jammu
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr. Kusum Verma

Jammu Institute of Ayurveda and Research Jammu

研究点 (1)

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