| CTRI Number |
CTRI/2025/01/079192 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to observe the Influence of Inter-Individual Variability in Body Constitution (Prakriti) on Cognitive Functions. |
|
Scientific Title of Study
|
Cross sectional Study on Association between Inter-Individual Variability in Body Constitution (Prakriti) and Cognitive Functions. |
| 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 Sadavrat Amlani |
| Designation |
Post Doctoral Fellowship in Integrative Mental Health and Neurosciences |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Integrative Medicine, National Institute of Mental Health and Neurosciences Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
7619961428 |
| Fax |
|
| Email |
sadavrat.amlani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishore kumar Ramakrishnan |
| Designation |
Professor of Ayurveda |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Integrative Medicine, National Institute of Mental Health and Neurosciences Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9845829174 |
| Fax |
|
| Email |
ayurkishore@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kishore kumar Ramakrishnan |
| Designation |
Professor of Ayurveda |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Integrative Medicine, National Institute of Mental Health and Neurosciences Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9845829174 |
| Fax |
|
| Email |
ayurkishore@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Integrative Medicine, National Institute of Mental Health and Neurosciences,Hosur Road, Bengaluru (Karnataka)-560029 |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Integrative Medicine National Institute of Mental Health and Neurosciences,Hosur Road, Bengaluru (Karnataka)-560029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Sadavrat Amlani |
Room No. G-13,Dept. of Integrative Medicine NIMHANS |
Hosur Road Hombegowda Nagar Bangalore
Bangalore
KARNATAKA |
7619961428
sadavrat.amlani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee for Research in AYUSH and integrative Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age group 18 years to 30 years |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | NIL | |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Human Volunteers (screening will be done by using Kessler Psychological Distress Scale (K10)) |
|
| ExclusionCriteria |
| Details |
1) Healthy Human Volunteers below 18 years or above 30 years of age. 2) Healthy volunteers having any Neuro-psychiatric disorder history. 3) Healthy volunteers with Alcohol dependency or any other addiction will be excluded from study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Digits Forward and Backward subtests.
2. Spatial Span Test (Corsi Block Test).
3. Trail Making Test (TMT) part A & B.
4. Stop Signal Task.
5. Rey Auditory Verbal Learning Test (RAVLT).
6. Rey Osterrieth Complex Figure (ROCF)Test. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mini Mental Status Examination for Attention, Memory & Intelligence |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
01/02/2025 |
| 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="8"
Days="0" |
|
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
|
1) Primary screening of participants will be done by using Kessler Psychological Distress Scale (K10) and eligibility will be assessed by Inclusion criteria. 2) Prakriti analysis of participants will be done using Brief Prakriti Inventory software. 3) Participants will be divided into 3 groups based on their prakriti-: Group A (Vata prakriti predominant, n=60); Group B (Pitta prakriti predominant, n=60) and Group C (Kapha prakriti predominant, n=60). 4) Application of following Cognitive Functions tests on participants using PEBL (Psychology Experiment Building Language) software and RED Cap software: 1. Digits Forward and Backward subtests:- for Attention and Verbal Working Memory. 2. Spatial Span Test (Corsi Block Test):- for Visual Working Memory. 3. Trail Making Test (TMT) part A & B:- for Processing speed and Set Shifting. 4. Stop Signal Task:- for Inhibitory Control (Response inhibition). 5. Rey Auditory Verbal Learning Test (RAVLT):- for New Learning and Recall (Auditory verbal). 6. Rey Osterrieth Complex Figure (ROCF)Test:- for New Learning and Recall (Visual). Based on the scores of these tests, different parameters used in these tests will be analysed to find any association between Prakriti and Cognitive Functions, through Statistical software/SPSS.
|