| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cognitively Healthy Individuals |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| 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. |