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CTRI Number  CTRI/2026/01/100790 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 16/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of Dementia Risk among Cognitively Healthy Adults with Different Deha Prakriti Using a Cognitive Risk Prediction Too 
Scientific Title of Study   Cross-Sectional study to Predict Dementia Risk among Cognitively Healthy Different Deha Prakriti Individuals with special reference to CogniPredict Tool. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Adinath Bhanudas Sawrate 
Designation  B.A.M.S PG Scholar 
Affiliation  Government Ayurved College, Nagpur 
Address  Government Ayurved College and Hospital Hospital, Raje Raghuji Nagar, Sakkardara square, Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  9503391514  
Fax    
Email  sawrateadinath5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Suwarna Dipak Vyas 
Designation  Associate Professor 
Affiliation  Government Ayurved College, Nagpur 
Address  Department of Kriya Sharir, Government Ayurved College and Hospital, Raje Raghuji Nagar, Sakkardara square, Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  9423404273  
Fax    
Email  dr.suwarnadvyas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Adinath Bhanudas Sawrate 
Designation  B.A.M.S PG Scholar 
Affiliation  Government Ayurved College, Nagpur 
Address  Government Ayurved College and Hospital Hospital, Raje Raghuji Nagar, Sakkardara square, Nagpur
Government Ayurved College and Hospital, Raje Raghuji Nagar, Sakkardara square, Nagpur
Nagpur
MAHARASHTRA
440024
India 
Phone  9503391514  
Fax    
Email  sawrateadinath5@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved College and Hospital,Nagpur 
 
Primary Sponsor  
Name  Adinath Bhanudas Sawrate 
Address  Government Ayurved College and Hospital, Raje Raghuji Nagar, Sakkardara, Nagpur 440024 
Type of Sponsor  Other [Self] 
 
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 
Adinath Bhanudas Sawrate  Government Ayurved College and Hospital, Nagpur and its periphery  Geriatric OPD NO. 02, ground floor
Nagpur
MAHARASHTRA 
9503391514

sawrateadinath5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics Committee Government Ayurved College, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Cognitively Healthy Individuals 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Individuals of age group of 45-60 yrs.
2.Participants who are cognitively healthy with no prior diagnosis of dementia.
3.Individuals willing to participate.
 
 
ExclusionCriteria 
Details  1.Individuals with History of neurological or psychiatric disorders (e.g., stroke, schizophrenia, epilepsy)
2.Diagnosed cases of mild cognitive impairment or dementia.
3.Individuals with severe systemic illness or chronic conditions affecting cognitive functions.
4.Individuals with Currently using psychoactive medications or cognitive-enhancing drugs.
5.Individuals addicted to alcohol or tobacco products.
6.Individuals with History of Covid-19.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To predict risk of dementia among cognitively healthy different Deha Prakriti individuals with special reference to Cognipredict Tool.

 
One Time Assessment
 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the risk factors for dementia among different Deha Prakriti individuals.
 
One Time Assessment 
To provide risk levels [normal/mild/severe] for different risk factors.
 
One Time Assessment 
To study the concept of Prakriti & dementia from available Samhitas & published literature.
 
One Time Assessment 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   19/02/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Dementia is a major public health problem characterized by progressive decline in cognitive functions, leading to functional impairment and loss of independence. Early identification of individuals at increased risk, prior to the onset of clinical dementia, is important for preventive and risk-reduction strategies. Ayurveda describes Deha Prakriti (Vata, Pitta, Kapha) as constitutional phenotypes influencing physical, physiological and psychological characteristics, which may be associated with variability in cognitive health.

This cross-sectional observational study aims to assess the predicted risk of dementia among cognitively healthy individuals aged 45–60 years with different Deha Prakriti types. A total of 120 participants will be recruited using a convenient sampling method. Deha Prakriti assessment will be carried out using the CCRAS Prakriti Parikshan proforma. Dementia risk prediction will be performed using the CogniPredict tool after screening for existing cognitive impairment using the CIBS Dementia-9 scale.

The primary outcome is the predicted dementia risk score across different Deha Prakriti groups. Secondary outcomes include identification of risk factor profiles and categorization of dementia risk levels. The study may contribute to early risk stratification and integrative preventive approaches for dementia.

 
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