| CTRI Number |
CTRI/2025/09/094716 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Diagnostic Preventive Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Establishing relationship in Between manas prakriti i.e.mental constitution with physiology of heart via ecg and evaluate the effect of medication on manas prakriti |
|
Scientific Title of Study
|
Analysis of manas prakriti with special reference to ECG and effect of Meditation on it. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashutosh Kumar |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurvedic college and Hospital KadamKuan patna Bihar |
| Address |
Government Ayurvedic college and Hospital patna, Kadamkuan 800003 Bihar At post Mahuawa police station chiraiya Dist. East champaran pincode 845415 Patna BIHAR 800003 India |
| Phone |
9852030672 |
| Fax |
|
| Email |
ashutoshkumargupta9852@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Simant Sourav |
| Designation |
Associate professor & HOD Department of Kriya sharir |
| Affiliation |
Government Ayurvedic college and Hospital KadamKuan patna Bihar |
| Address |
Government Ayurvedic college and Hospital patna, Kadamkuan 800003 Bihar
Patna BIHAR 800003 India |
| Phone |
7060197269 |
| Fax |
|
| Email |
drsimant.sourav@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Simant Sourav |
| Designation |
Associate professor & HOD Department of Kriya sharir |
| Affiliation |
Government Ayurvedic college and Hospital KadamKuan patna Bihar |
| Address |
Government Ayurvedic college and Hospital patna, Kadamkuan 800003 Bihar
Patna BIHAR 800003 India |
| Phone |
7060197269 |
| Fax |
|
| Email |
drsimant.sourav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic college and Hospital Kadamkuan patna
Pincode-800003 City patna State Bihar |
|
|
Primary Sponsor
|
| Name |
Ashutosh Kumar |
| Address |
Budhhamurti,kadamkuan, patna 800003, Bihar |
| 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 Ashutosh kumar |
Government ayurvedic College and hospital, patna bihar 800003 |
1st floor near principal office Department of kriya sharir and Physiology laboratory Patna BIHAR |
9852030672
ashutoshkumargupta9852@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurvedic Collage and Hospital Patna Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening and observation of heart physiology via ECG. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | satvAvajaya-cikitsA, सत्वावजय-चिकित्सा | (Procedure Reference: meditation as medicine a book by Dharma singh Khalsa,M.D. And Cameron stauth foreword by Joan Borysenko, Ph.d, Procedure details: Duration-3 months
frequency-10-15min/day
technique-focus on breathing
)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
Only healthy individual |
|
| ExclusionCriteria |
| Details |
Those with age less than 20 years and more than 30 years
Female individual |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Thesis would aim to elucidate how do you know different Manas prakriti types correlate with physiology of heart via ECG and to what extent the practice of meditation influences Manas dosha Guna and physiology of heart via ECG. |
Its 90 days trial.The Thesis would aim to elucidate how do you know different Manas prakriti types correlate with physiology of heart via ECG and to what extent the practice of meditation influences Manas dosha Guna and physiology of heart via ECG. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
improvement in overall behavior
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/09/2025 |
| 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="3" 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 - NO
|
|
Brief Summary
|
CVD is the leading cause of death all over the world and accounts for 30% of death worldwide Evidences shows effectiveness of healthy dietary patterns and life styles for prevention of CVD.
As per Ayurveda, Aahar and lifestyle pattern of an individual are decided by Manas prakriti of the individual, meditation tends to improve the Sattvu contained of Manas by decreasing the proportion of Rajas and Tamas.
When Manas Prakriti of an individual improves the lifestyle and dietary pattern improves, hence the health of the heart improves and incidence of the CVD decreases. Heart functioning can be monitored by ECG. Meditation may be an effective tool to reduce Rajas and Tamas Doshas and to maintain ECG with in normal limit. Hence the topic was selected for analysis. |