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临床试验/CTRI/2024/05/067821
CTRI/2024/05/067821尚未招募2/3 期

A Clinico Comparative Study Between Virechana Karma And Matra Basti In The Management Of Pakshaghata W.S.R. To Hemiplegia An Open Labelled Randomized Comparative Clinical Trial

Government Akhandanand Ayurved College And Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月1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
20
试验地点
1
主要终点
To improve the disability produced by Pakshaghata.

研究概览

简要总结

RESEARCH QUESTION:

                Is Virechana karma as effective as Matra Basti in the management of Pakshaghata ?

HYPOTHESIS:

Null Hypothesis [ H0]: There is no significant difference in the effect between Virechana Karma and Matra Basti in the management of Pakshaghata.

Alternative Hypothesis:

[ H1]: The effect of Virechana Karma is more significant than the effect of Matra Basti in the management of Pakshaghata.

[ H2]: The effect of Matra Basti is more significant than the effect of Virechana Karmain the management of Pakshaghata.

AIM:

To evaluate and compare the effect of Virechana karma and Matra Basti in the management of Pakshaghata.

 OBJECTIVES:

· To study the  complete aetiopathology, symptomatology and progress of Pakshaghata according to Ayurveda as wells as modern science.

·  To Study  Virechana karma as per ayurvedic texts.

·  To Study Basti karma  as per ayurvedic texts.

To observe and analyse the effect of Virechana karma and Matra Basti in the management of Pakshaghata.

DIAGNOSTIC CRITERIA:

Subjective criteria

Vama paksha or dakshina paksha chesta nivrutti (Diminished movements).

Vak stambh (Impaired speech).

Pada sankocha (contracture of lower limb).

Hasta sankocha (contracture of upper limb).

Gamane kashtata (difficulty in walking).

 Objective criteria

· Examination

·         NIH STROKE SCALE

·         Neurological Examination(Higher Mental Functions,Cranial Nerves,Motor Functions,Sensory Function,Gait,etc) will be done before and after treatment.

   Â· Investigations

Following investigations will be carried out before and after treatment.

v  Hematological examination – CBC WITH ESR.

v  Bio-chemical examination –Electrolyte, RBS, Urine Routine & Microscopy

v  Lipid profile (If Required)

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex with age between more than 18 to less then 60 years.
  • Patient having signs and symptoms of Pakshaghata fulfilling diagnostic criteria.
  • Patients who are Yogya for Virechana Karma and Basti Karma.
  • Mild to moderate hypertensive shall be considered.
  • Chronicity of disease limits upto 5 year.

排除标准

  • Patient having age less then 18 and more than 60 years.
  • Patients who are Ayogya for Virechana Karma and Basti Karma.
  • Uncontrolled hypertension.
  • Patients of Intracranial infection on the basis of previously done Investigation.
  • Intracranial space occupying lesions and trauma on the basis of previously done Investigation.
  • Patients with altered sensorium.
  • Chronicity of disease limits more than 5 year.

结局指标

主要结局

To improve the disability produced by Pakshaghata.

时间窗: follow up will be done weekly for 1 month.

次要结局

  • To improve quality of life of patient(follow up will be done weekly for 1 month.)

研究者

发起方
Government Akhandanand Ayurved College And Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Yagnitsinh Viharia

Government Akhandanand Ayurved College Ahmedabad Gujarat India 380001

研究点 (1)

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