| CTRI Number |
CTRI/2025/01/079798 [Registered on: 30/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Methodological study design |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Intelligence and Decision-Making Abilities in Adults Using a New Evaluation Tool" |
|
Scientific Title of Study
|
DEVELOPMENT AND VALIDATION OF AN ASSESSMENT TOOL FOR EVALUATING BUDDHI IN ADULTS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMRUTA VEDPATHAK |
| Designation |
PhD Scholar |
| Affiliation |
G J PATEL INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH |
| Address |
DEPARTMENT OF KRIYA SHARIR G J PATEL INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH CENTRE NEW VALLABH VIDYANAGAR ANAND GUJARAT
DEPARTMENT OF KRIYA SHARIR G J PATEL INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH CENTRE NEW VALLABH VIDYANAGAR ANAND GUJARAT
Anand
GUJARAT
388120
India |
| Phone |
9284373383 |
| Fax |
|
| Email |
vdamrutaved@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SARITA S BHUTADA |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
G J PATEL INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF KRIYA SHARIR G J PATEL INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH CENTRE NEW VALLABH VIDYANAGAR ANAND GUJARAT
DEPARTMENT OF KRIYA SHARIR GROUND G J PATEL INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH CENTRE NEW VALLABH VIDYANAGAR ANAND GUJARAT
Anand
GUJARAT
388120
India |
| Phone |
9422348655 |
| Fax |
|
| Email |
sarita.bhutada@cvmu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
AMRUTA VEDPATHAK |
| Designation |
PhD Scholar |
| Affiliation |
G J PATEL INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH |
| Address |
DEPARTMENT OF KRIYA SHARIR G J PATEL INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH CENTRE NEW VALLABH VIDYANAGAR ANAND GUJARAT
DEPARTMENT OF KRIYA SHARIR G J PATEL INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH CENTRE NEW VALLABH VIDYANAGAR ANAND GUJARAT
Anand
GUJARAT
388120
India |
| Phone |
9284373383 |
| Fax |
|
| Email |
vdamrutaved@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amruta Vedpathak Self Funded Project PhD Scholar DEPARTMENT OF KRIYA SHARIR G J PATEL INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH CENTRE NEW VALLABH VIDYANAGAR ANAND GUJARAT india 388120 |
|
|
Primary Sponsor
|
| Name |
Amruta vedpathak |
| Address |
ASSISTANT PROFESSOR of kriya sharir department ground floar LRP AYURVEDA MEDICAL COLLEGE sangli road Urun Islampur tq-walawa dist-Sangli maharashtra 415409 india |
| 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 |
| Amruta |
LRP AYURVEDA MEDICAL COLLEGE & HOSPITAL |
kriya sharir department ground floar LRP AYURVEDA MEDICAL COLLEGE HOSPITAL sangli road Urun Islampur tq-walawa dist-Sangli maharashtra 415409 india
Sangli
MAHARASHTRA |
9284373383
vdamrutaved@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics CommitteeG.J Patel institute of Ayurvedic studies and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Good Physical and Mental Health status |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Participants must express a genuine interest in the study and be willing to complete the assessment tool, |
|
| ExclusionCriteria |
| Details |
Severe cognitive impairment volunteers will be excluded.
Psychiatric Disorder volunteers will be excluded.
Neurological Condition volunteers will be excluded.
Concurrent Participants will be excluded. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Standedized tool will be available For the assessment of Buddhi in Adults specifically tailaired on ayurvedic principles |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| new scale development on ayurveda principles |
3 years |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
07/02/2025 |
| 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="3"
Months="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vdamrutaved@gmail.com].
- For how long will this data be available start date provided 01-02-2025 and end date provided 25-03-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
To develop and validate the Buddhi assessment scale in adults on the Ayurvedic principles |