跳至主要内容
临床试验/CTRI/2024/06/069268
CTRI/2024/06/069268尚未招募Phase 3 4

An Open Labelled Randomised Controlled Clinical Study to evaluate the efficacy of Ksheerbala Tail Nasya and Ashwagandha Tail Nasya in the management of cervical spondylosis

Institute for Ayurved Studies & Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月3日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Reduction in scoring pattern of subjective parameters of Cervical Spondylosis like Pain, Stiffness, Tenderness, Headache, Vertigo, Tingling sensation and Sensory loss.

研究概览

简要总结

Cervical pain is experienced by all most all individuals in their life span and disturbs the routine. Cervical spondylosis is due to a degeneration at the level of Cervical spine or an inflammatory reaction in association with an early degenerative change at that level. In Ayurvedic context, sign and symptoms of Cervical spondylosis is best correlates with asthi-majjagat vata. As Cervical spondylosis is one of the conditions occurring at manya pradesh, hence it is urdhwajatrugata vikara so nasya is the choice of treatment. As it is a degenerative disorder so brhimhana, vatashamaka and dhatuposhak ausdhi will be admisinistered. As bala and ashwagandha possess madhur, snigdha and dhatuposhak properties the efficacy of ksheerbala tail nasya in Cervical spondylosis is proved in previous research work. No work is done yet on ashwagandha tail nasya in Cervical spondylosis so this comparative study is selected for research.

Aim: To evaluate the efficacy of ashwagandha tail nasya in management of Cervical spondylosis.

Objective: To evaluate efficacy of ashwagandha tail nasya in comparison with ksheerbala tail nasya in management of Cervical spondylosis.

Methodology: Total 60 patients of Cervical spondylosis will be selected randomly and divided in to 2 groups i.e. Group A (ksheerbala tail nasya) and group B (ashwagandha tail nasya). Nasya will be given for 7 sittings between 7-21 days in dose of 8 bindu in each nostril. And observation will be done on basis of before and after subjective and objective parameters.

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
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1 Patients willing to sign the consent form.
  • 2 Patients aged between 25 and 55 yrs of either sex.
  • 3 Patients having signs and symptoms of cervical spondylosis exceeding not more than 3 years with or without radiological changes.
  • 4 Patients fit for Nasya Karma.

排除标准

  • 1 Patients having age below 25 and above 55 yrs of either sex.
  • 2 Patients with chronicity of more than 3 years.
  • 3 Patients unfit for Nasya karma.
  • 4 Patients not willing for the Nasya karma.
  • 5 Patients diagnosed with Myelopathy or stenosis of Spinal Canal, and other related conditions like Ankylosing spondylitis.
  • 6 Patient diagnosed with Tuberculosis of spine, spinal tumors, Vascular lesions, Neoplasms, history of trauma, fractures and surgical history.
  • 7 Patients having any other systemic disorders like cardiac disease, renal diseases and hypertension or endocrinal disorders.
  • 8 Pregnant or lactating mothers.

结局指标

主要结局

Reduction in scoring pattern of subjective parameters of Cervical Spondylosis like Pain, Stiffness, Tenderness, Headache, Vertigo, Tingling sensation and Sensory loss.

时间窗: On 1st, 8th, 15th day of treatment

Reduction in scoring pattern of objective parameters of Cervical Spondylosis like ROM of neck flexion, extension, lateral rotation, lateral flexion, Reflexes, Muscle power strength.

时间窗: On 1st, 8th, 15th day of treatment

次要结局

  • To relief the pain and discomfort of patients suffering from Cervical Spondylosis(On 1st, 8th, 15th day of treatment)

研究者

发起方
Institute for Ayurved Studies & Research
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Surbhi

Institute for Ayurved Studies and Research

研究点 (1)

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