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临床试验/CTRI/2024/11/077223
CTRI/2024/11/077223尚未招募不适用

To Study the Impact of Prakriti on Frequency and Severity of Ardhavbhedaka w.s.r to Migraine in Adults- A Cross Sectional Study

Ch Brahm Prakash Ayurveda Charak Sansthan1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
138
试验地点
1
主要终点
Association between Prakriti and Frequency and Severity of Ardhavbhedaka(Migraine)in Adults.

研究概览

简要总结

ABSTRACT OF THE RESEARCH PROPOSAL

One of the most frequent complaints that people bring to the outpatient department (OPD) and

occasionally the emergency room of a hospital is headache. One of the main symptoms of

Ardhavbhedaka, a kind of Shiroroga, is unilateral headache of variable intensity. Several

Acharyas have said it among the Shirorogas., There is excruciating pain in half of the skull

namely Manya, Shankha,Akshi,Karna,Bhru and Lalaata.The type of discomfort is comparable to

that caused by sharp items such as Arani and Shastra. Pain is a subjective experience that varies

from person to person. Ardhavbhedaka can cause problems like blindness and hearing loss if it is

improperly managed or left untreated (Nayana and Sravana vinasha). Based on the clinical signs

and symptoms, this illness can be linked to migraine, a specific kind of headache. A type of

primary headache known as a migraine is characterized by frequent episodes of pulsating

headaches, usually accompanied by nausea, vomiting, photophobia, and phonophobia, either

with or without an aura..For those in the 30 to 50 year-old age group, migraine is a serious health

concern. With an estimated global frequency of 14.7%, migraine is the third most frequent

medical illness worldwide, according to the World Health Organization. In a 3:1 ratio, females

are typically more impacted than males.Prakriti(body constitution) is an important fundamental

concept of Ayurveda explained by various Acharyas. My research work focuses on determining

the impact of Prakriti on frequency and severity of Ardhavbhedaka w.s.r to migraine in adults.

KEYWORDS: Ardhavbhedaka, Migraine, Shiroroga, Headache, Prakriti

DETALED RESEARCH PROPOSAL

TITLE OF PROJECT

“To Study the Impact of Prakriti On Frequency And Severity of Ardhavbhedaka w.s.r to

Migraine In Adults – A Cross- Sectional Study”

INTRODUCTION

Not much fundamental research has been done with reference to Prakriti and the frequency & severity

of Ardhavbhedaka (Migraine).

In day- to- day life, there are many patients with Ardhashirshoola(unilateral headache) which is

the cardinal symptom of Ardhavbhedaka.. Due to pain, patients could not able to perform their

day to day work properly and want to get rid of this problem permanently.

Prakriti (body constitution) is one of the most important concepts of Ayurveda and it is decided at

the time of conception. Whichever dosha predominates at the time of union of sukra and sonita,

the doshika constitution is determined accordingly.It is an expression of body functions in the form

of morphology, physiology and behaviour of an individual. Prakriti indicates a phenotypic and

genotypic constitution.Prakriti is of seven types, i.e., three according to each dosha, Vataj, Pittaj,

Kaphaj, three according to the combination of two doshas (Dwandwaj) and one due to all the three

doshas together (Samadoshaj). Among these, samadoshaj is considered as an excellent one

because of homeostatic state of dosha. Each prakriti has specific physical and mental

characteristics that totally depend on the involvement of dosha Some are vatal (having the

dominance of vata), pittala (having dominance of pitta) , slesmla (having dominance of

kapha).Vatala, pittala, and slesmala types of individuals are susceptible to vatika, paittika and

slaismika diseases respectively and such diseases in the respective types of individuals become

very severe.

There are 107 Marmas in the human body and the Pradhana Marma is Shiras. Shiras is considered

as “Uttamanga” among all the Angas of the Sharira and it is the Ashraya of the Prana and all Indriyas.

Ardhavbhedaka Roga is one among the various Shirorogas mentioned in Ayurvedic texts.

The word Ardhavbhedaka comprises of two components viz. Ardha and Avbhedaka. Ardha means

half or half side, Ava suggests bad prognosis and Bhedaka means breaking, perforating or bursting out type of pain. Thus, literal meaning of Ardhavbhedaka is perforating or bursting out like pain in

one half of the head (may be right or left).

According to Acharya Sushruta, symptoms of Ardhavabhedaka include

यस्योत्तमाङ्गार्द्धमतीव

सम्भेदतोदभ्रमशूलजुष्टम्।

पक्षाद् दशाहादथवाऽप्यकस्मा त्तस्यार्द्धभेदं त्रितयाद्वयवस्येत्

(Su.Ut27/15).

Severe pain of tearing and pricking nature affects one half of the head and appears periodically in

the form of episodes. Headache appearing in the form of intervals of 10 or 15 days without any

known cause is called Ardhavabhedaka.

OBJECTIVES OF THE STUDY

PRIMARY OBJECTIVES

  1. To assess frequency and severity of Ardhavbhedaka(Migraine) on the basis of MIDAS Score (Migraine Disability

Assessment Score).

  1. To assess Prakriti of the subjects using a validated Prakriti Performa.

SECONDARY OBJECTIVES

  1. To determine the association between Prakriti with frequency & severity of Ardhavbhedaka(Migraine)

  2. To assess the impact of other covariates- age, gender, food habits, sleep pattern with frequency and severity of

Ardhavbhedaka (Migraine)

RESEARCH QUESTION

Is there any impact of Prakriti on frequency & severity of Ardhavbhedaka(Migraine) in adults?

NULL HYPOTHESIS

There is no any impact of Prakriti on frequency & severity of Ardhavbhedaka(Migraine) in adults.

ALTERNATIVE HYPOTHESIS

There is impact of Prakriti on frequency & severity of Ardhavbhedaka(Migraine) in adults.

METHODOLOGY

MATERIAL AND METHODS

The subjects will be randomly selected irrespective of gender or socio- economic condition from

CBPACS OPD.

Diagnostic Criteria

Patients will be diagnosed based on the following signs and symptoms-

  1. Ardhamurdha Vedana

  2. Bhedtodavat Vedana

  3. Bhrama

  4. Manya,Bhru,Shankha,Karna,Akshi,Lalata ardhe Vedana

Clinical manifestations like recurrent attacks of headache,mostly unilateral in nature,variable in

intensity,frequency and duration ,nausea, vomiting ,photophobia, phonophobia and vertigo as per modern

texts are used also for diagnostic purpose.

INCLUSION CRITERIA:

a. Individuals suffering from Ardhavbhedaka irrespective of gender and socio-economic status.

b. Patient having the signs and symptoms of Ardhavbhedaka as mentioned in the classical and

modern literature.

c. Age group 18-50 years

d. Subjects who can give their history and details for assessment on their own.

EXCLUSION CRITERIA

a. Age group below the 18 years and above the 50 years.

b. Patients having history of head trauma.

c. Subjects who cannot give their history and assessment details on their own.

d. Patients suffering from secondary headache caused by meningitis, brain tumour, encephalitis,

cervical spondylitis, uncorrected refractive errors, sinus headache etc.

e. Patients suffering from any chronic illness like hypertension, heart disease, diabetes mellitus, tuberculosis,cancer etc

METHODOLOGY OF THE STUDY

  1. Frequency & severity of Ardhavbhedaka (Migraine) will be

assessed on the basis of MIDAS score.

  1. On the basis of the Inclusion criteria, patients will be selected

from the OPD of CBPACS.

  1. Prakriti will be assessed by using validated Prakriti

Performa by Department of Kriya Sharir, CBPACS

(Self –Assessment Questionnaire To Determine Prakriti)

  1. The impact of other covariates- age, gender, food habits, sleep

pattern with frequency and severity of Ardhavbhedaka (Migraine)

will be assessed.

5.The data will be compiled and the association between Prakriti and

frequency & severity of Ardhavbhedaka (Migraine) will be

analyzed with relevant statistical methods.

  1. The findings will be compiled in the form of the thesis.

STUDY DESIGN-Cross –Sectional Study

DURATION OF STUDY-12 MONTHS

SAMPLE SIZE -138

FOR CALCULATION OF SAMPLE SIZE.

DANIEL FORMULA

N=Z2P(1-P)/D2

N=No. Of Subjects/Sample Size

Z=1.96 (Z Score corresponding to the desired confidence level i.e 1.96 for 95% confidence)

P=Expected prevalence of MIGRAINE=10%

D= 0.05 (Desired margin of error i.e 5%)

By above Formula, Sample Size for Study Comes out to be= 138

STATISTICAL ANALYSIS

Data will be compiled and statistically analyzed to draw specific conclusion and inferences.

Following statistical test may be used in this study-

  1. One- Way ANOVA to establish relationship between Prakriti & MIDAS Score.

  2. Chi-Square Test will be used to find association between Prakriti & frequency and severity

Ardhavbhedaka(Migraine).

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Individuals suffering from Ardhavbhedaka irrespective of gender and socio-economic status b.
  • Patient having the signs and symptoms of Ardhavbhedaka as mentioned in the classical and modern literature.
  • Age group 18-50 years d.
  • Subjects who can give their history and details for assessment on their own.

排除标准

  • Age group below the 18 years and above the 50 years.
  • Patients having history of head trauma.
  • Subjects who cannot give their history and assessment details on their own.
  • Patients suffering from secondary headache caused by meningitis, brain tumour, encephalitis, cervical spondylitis, uncorrected refractive errors, sinus headache etc.
  • Patients suffering from any chronic illness like hypertension, heart disease, diabetes mellitus, tuberculosis,cancer etc.

结局指标

主要结局

Association between Prakriti and Frequency and Severity of Ardhavbhedaka(Migraine)in Adults.

时间窗: At baseline

次要结局

  • There may be variations in Frequency & Severity of Ardhavbhedaka(Migraine) on the basis of other covariates like age, gender,food habits, sleep pattern of the subjects.(10 months)

研究者

发起方
Ch Brahm Prakash Ayurveda Charak Sansthan
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Shalini Prakash

Ch Brahm Prakash Ayurveda Charak Sansthan

研究点 (1)

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