| CTRI Number |
CTRI/2025/04/085962 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Observational Study on Manasa Prakruti and Mental Wellbeing |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY TO EXPLORE THE RELATIONSHIP BETWEEN MANASA PRAKRUTI & PSYCHOLOGICAL PARAMETERS |
| 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 KALPTARU ROY |
| Designation |
PG SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVED AND RESEARCH |
| Address |
DEPARTMENT OF KRIYA SHARIR PARUL INSTITUTE OF AYURVED AND RESEARCH PARUL UNIVERSITY LIMDA WAGHODIA VADODARA GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
8962594016 |
| Fax |
|
| Email |
kalptaruroy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MARIYA HUSAIN |
| Designation |
PROFESSOR |
| Affiliation |
PARUL INSTITITE OF AYURVED AND RESEARCH |
| Address |
DEPARTMENT OF KRIYA SHARIR PARUL INSTITUTE OF AYURVED AND RESEARCH PARUL UNIVERSITY LIMDA WAGHODIA VADODARA GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
8329771085 |
| Fax |
|
| Email |
drmariya24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MARIYA HUSAIN |
| Designation |
PROFESSOR |
| Affiliation |
PARUL INSTITITE OF AYURVED AND RESEARCH |
| Address |
DEPARTMENT OF KRIYA SHARIR PARUL INSTITUTE OF AYURVED AND RESEARCH PARUL UNIVERSITY LIMDA WAGHODIA VADODARA GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
8329771085 |
| Fax |
|
| Email |
drmariya24@gmail.com |
|
|
Source of Monetary or Material Support
|
| KHEMDAS HOSPITAL PARUL UNIVERSITY VADODARA INDIA 391760 |
|
|
Primary Sponsor
|
| Name |
DR KALPTARU ROY |
| Address |
DEPARTMENT OF KRIYA SHARIR PARUL INSTITUTE OF AYURVED AND RESEARCH, PARUL UNIVERSITY VADODARA GUJARAT 391760
PARUL UNIVERSITY VADODARA GUJARAT |
| 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 |
| DR KALPTARU ROY |
KHEMDAS HOSPITAL |
Room no. 201,1st floor, department of Kriya Sharir,PARUL UNIVERSITY VADODARA GUJARAT
Vadodara
GUJARAT |
8962594016
kalptaruroy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIAR-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY HUMAN INDIVIDUAL |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers willing to provide consent to participate in the study.
Volunteers in an Age group ranging from 18 to 30 years.
Volunteers of both genders irrespective of religion, caste, and creed |
|
| ExclusionCriteria |
| Details |
Those who are suffering from chronic illnesses
Suffering or with a history of any psychological disorders like Schizophrenia, Psychosis, etc.,
Subjects suffering from congenital, anatomical deformities
Subjects suffering from any major systemic diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the association between Manasa Prakruti types and psychological well-being. |
1.8 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyze the correlation between Manasa Prakruti and specific psychological traits. |
1 DAY |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
16/05/2025 |
| 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="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
This observational study aims to investigate the relationship between Guna Pradhana Manasa Prakruti (Satwika, Rajasika, Tamasika) and psychological parameters such as depression, anxiety, and stress. Rooted in Ayurvedic principles, the research hypothesizes that individuals with different mental constitutions (Manasa Prakruti) exhibit varied susceptibility to psychological conditions. A total of 300 healthy volunteers aged 18–30 years from Parul University will be assessed using Ayusoft software for Manasa Prakruti and DASS-42 scale for psychological parameters. The study seeks to support a personalized, preventive, and integrative approach to mental health through the lens of Ayurveda. |