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CTRI Number  CTRI/2024/11/077223 [Registered on: 22/11/2024] Trial Registered Prospectively
Last Modified On: 20/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding the Role of Body Constitution (Prakriti) in Migraine Patients 
Scientific Title of Study   To Study the Impact of Prakriti on Frequency and Severity of Ardhavbhedaka w.s.r to Migraine in Adults- A Cross Sectional Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalini Prakash 
Designation  Assistant Professor  
Affiliation  Ch Brahm Prakash Ayurveda Charak Sansthan  
Address  Room No.-333,3rd Floor, Division-Institute Block,PG Department of Kriya Sharir
Ch Brahm Prakash Ayurveda Charak Sansthan, Khera Dabar,Najafgarh,Delhi-110073 Room No.-333,3rd Floor, Division -Institute Block,PG Department of Kriya Sharir
South West
DELHI
110073
India 
Phone  9818180526  
Fax    
Email  drshaliniprakash007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhishek Gupta 
Designation  POST GRADUATE SCHOLAR 
Affiliation  Ch Brahm Prakash Ayurveda Charak Sansthan  
Address  Room No.-333,3rd Floor, Division-Institute Block,PG Department of Kriya Sharir
Ch Brahm Prakash Ayurveda Charak Sansthan, Khera Dabar,Najafgarh,Delhi Room No.-333,3rd Floor, Division-Institute Block,PG Department of Kriya Sharir
South West
DELHI
110073
India 
Phone  8802230661  
Fax    
Email  gupta.abhi311095@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhishek Gupta 
Designation  POST GRADUATE SCHOLAR 
Affiliation  Ch Brahm Prakash Ayurveda Charak Sansthan  
Address  Room No.-333,3rd Floor, Division-Institute Block,PG Department of Kriya Sharir
Ch Brahm Prakash Ayurveda Charak Sansthan, Khera Dabar,Najafgarh,Delhi Room No.-333,3rd Floor, Division-Institute Block,PG Department of Kriya Sharir
South West
DELHI
110073
India 
Phone  8802230661  
Fax    
Email  gupta.abhi311095@gmail.com  
 
Source of Monetary or Material Support  
Ch Brahm Prakash Ayurveda Charak Sansthan ,Khera Dabar ,Najafgarh , India, New Delhi-110073 
 
Primary Sponsor  
Name  Ch Brahm Prakash Ayurveda Charak Sansthan  
Address  Khera Dabar Najafgarh Delhi-110073  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shalini Prakash   Ch Brahm Prakash Ayurveda Charak Sansthan   Room No-333,3rd Floor,Division-Institute Block, PG Department of Kriya Sharir, Khera Dabar,Najafgarh, New Delhi-110073
South West
DELHI 
9818180526

drshaliniprakash007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ch Brahm Prakash Ayurveda Charak Sansthan   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association between Prakriti and Frequency and Severity of Ardhavbhedaka(Migraine)in Adults.  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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
 à¤¯à¤¸à¥à¤¯à¥‹à¤¤à¥à¤¤à¤®à¤¾à¤™à¥à¤—ार्द्धमतीव
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).
2. 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.

2. On the basis of the Inclusion criteria, patients will be selected
from the OPD of CBPACS.

3. Prakriti will be assessed by using validated Prakriti
Performa by Department of Kriya Sharir, CBPACS
(Self –Assessment Questionnaire To Determine Prakriti)

4. 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.

6. 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).

 
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