FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062936 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 20/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Determine prakriti in patient of knee pain  
Scientific Title of Study   Assessment of Prakriti in Sandhigat vata w.s.r. to preventive concept– 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 M.B.Gaur 
Designation  Director -Principal, Professor, Head of Department  
Affiliation  CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN 
Address  Room No.334, 3rd floor,PG dept. of kriya sharir, CBPACS, KHERA Dabar,Najafgarh,Southwest New Delhi South West DELHI 110073 India

South West
DELHI
110073
India 
Phone  9968838331  
Fax    
Email  manubhaigaur@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arati Ashok Nirmale 
Designation  PG Scholar (Dept. of kriya sharir) 
Affiliation  CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN 
Address  Ch.brahm prakash ayurveda charak Sansthan, khera dabar ,Najafgarh,Southwest New Delhi South West DELHI 110073 India

South West
DELHI
110073
India 
Phone  9518394243  
Fax    
Email  shaliniadh2596@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arati Ashok Nirmale 
Designation  PG Scholar (Dept. of kriya sharir) 
Affiliation  CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN 
Address  Ch.brahm prakash ayurveda charak Sansthan, khera dabar ,Najafgarh,Southwest New delhi South West DELHI 110073 India

South West
DELHI
110073
India 
Phone  9518394243  
Fax    
Email  shaliniadh2596@gmail.com  
 
Source of Monetary or Material Support  
Ch. brahm prakash ayurved charak sansthan 
 
Primary Sponsor  
Name  Ch brahm prakash ayurveda charak Sansthan  
Address  Khera dabar, najafgarh, New Delhi 
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 Arati Ashok Nirmale  Ch. brahm prakash ayurved charak sansthan  CBPACS,PG dept. of kriya sharir, institute block, 3rd floor, khera dabar, southwest, new delhi KHERA DABAR,N ajafgarh,northwest NEW DELHI South West DELHI
South West
DELHI 
9518394243

shaliniadh2596@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-CBPACS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Diagnosed cases of osteoarthritis irrespective of gender and socio-economic status
2. Age group 40- 60 years old.
3. Subjects who can give their history and details for assessment on their own. 
 
ExclusionCriteria 
Details  1. Age below the 40 years and above the 60 years.
2.Subjects who cannot give their history and assessment details on their own.
3,Subjects who are bed –ridden.
4.Subjects suffering from carcinomatous or other infectious disorders. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess prakriti in patient of sandhigata vata (osteoarthritis) by using WOMAC SCALE of 100 sample size.
 
12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
It will help in determining daily regimen & dietary recommendations.
It will help in preventative care of sandigata vata / osteoporosis patients
 
1 month 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/03/2024 
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="0"
Months="6"
Days="5" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Introduction-
Prakriti is one of the most important concepts and it is decided at the time of conception.
Whichever dosha predominantes at the time of union of sukra and sonita, the doshika constitution
is determined accordingly.1
It is an expression of body functions, in the form of morphology,
physiology, behaviour of an individual. Prakriti indicates toward phenotypic and genotypic
constitution.2Prakriti 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 which
totally depend on the involvement of dosha.3 Prakriti means a normal or naturals state and there
should not be any dominance of doshas in the bodies of individuals. So such individuals as are
having the dominance of one or the other of the doshas cannot be described to have the normal
states of their body.4 Thus to use the correct term, they 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.5
In ayurveda all arthritic diseases are included in relation with asthi dhatu pradoshaj vikaraj
according to ayurveda we can correlate osteoarthritis with it as sandhigat vata osteoarthritis is by
far the most common form of arthritis .it is strongly associated with ageing and is a major cause
of pain and disability in older people. Pathologically ,it may be defined as a condition of synovial
joints characterized by focal loss of articular hyaline cartilage with proliferation of new. bone and
remodel ing of joint contour inflammation is not a prominent clinical feature. OA and
preferentially targets certain small and large joints but it Is not a disease or a single condition it
is best viewed as the dynamic repair process of synovial joints that may be triggered by a variety
of insults ,some but not all of which result in symptomatic joint failure. There are actually two
types of osteoarthritis; primary and secondary .These two forms of OA have the same symptoms
but, different causes .both primary and secondary OA involve the breakdown of cartilage in . joints
,which causes bones to rub together .osteoarthritis is the second most common rheumatologic
problem and it is the most frequent joint disease with a prevalence of 22%-39% in India OA is
more common in women than men .Nearly 45% of women over the age of 65 years have symptoms
while 70% of those over 65 years show radiological evidence of OA. This is because of the genetic predisposition of Indians towards knee arthritis, and a lifestyle that results in overuse of the knee
joints. The main challenges in treating joint replacements are the financial incapacity of patients
and deficient awareness among the people about health insurance. Among the chronic rheumatic
diseases hip and knee osteoarthritis is the most prevalent and is leading cause of pain and disability
in most countries world wide,its prevalence increases with age and generally affects women more
frequently than men. Determining region specific OA prevalence and risk factor profiles will
provide important information for planning future cost effective preventive strategies and health
care services.
Research question
Is there any association between Prakriti and osteoarthritis
Hypothesis
Null hypothesis
There is no co-relation between Prakriti and osteoarthritis
Alternative hypothesis
 There is co-relation between Prakriti and osteoarthritis
Lacunae in existing knowledge
Not much fundamental research has been done with reference to Prakriti and osteoarthritis
Manifestation of osteoarthritis in different Prakriti has not been studied in much detail before.
 Study on osteoarthritis its symptoms and prevalence rate has been done.
 Previous work done: -
• Efficacy of leech therapy in the management of osteoarthritis.(RAI PK
AYU,2011)
• Clinical study of Agnikarma and pachatikta guggul in the management of
sandhivata (SHARMAAV AYU 2016)
• Clinical evaluation of Boswellia errata(shallaki)resin in the management of
sandhivata .GUPTA PK 2011
• Clinical evaluation of nirgundi taila in the management of sandhivata
 DAS B Anc sci life 2003
Outcome of the study-
By this study after assessment of prakriti in sandhigat vata we can design lifestyle and
treatment protocols and preventive measures could be taken if prevalence of sandhigata
vata studied in different prakriti subjects
NEED OF THE STUDY: -
•Rise in environmental and genetic changes, which are implicated in the pathogenesis of
Sandhigata vata further indicates its increasing prevalence and incidence in coming future.
• By assessing the Prakriti of individuals suffering from sandhigata vata we can design lifestyle 
and treatment protocol accordingly.
• By assessing Prakrit; disease outcome and severity can be predicted.
• Preventive measures could be taken if prevalence of sandhigata vata isstudied in different
constitution subjects.
 Aim & objectives -
 Aim-To assess Prakriti in sandhigata vata w.s.r to preventive concept.
Objectives –
• To determine sandhigata vata based on the diagnosis as mentioned in different 
classical text and osteoarthritis diagnosis on the basis WOMAC score.
• Prakriti will be assessed by using a validated Dr. (Prof.) Kishor Patwardhan BHU
Prakriti Performa
• To determine the co-relation between Prakriti and osteoarthritis, .
Inclusion criteria:
1. Diagnosed cases of osteoarthritis irrespective of gender and socio-economic status
2. Age group 40- 60 years old.
3. Subjects who can give their history and details for assessment on their own.
Exclusion criteria:
1. Age below the 40 years and above the 60 years.
2.Subjects who cannot give their history and assessment details on their own.
3,Subjects who are bed –ridden.
4.Subjects suffering from carcinomatous or other infectious disorders.
 
Close