| CTRI Number |
CTRI/2025/06/089689 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Effectiveness of Yog nidra on Raja guna in Sleep Deprived Working Young professional |
|
Scientific Title of Study
|
A Single arm Clinical study for Status of Raja Guna in sleep deprived working young professional with special reference to intervention of Yog nidra |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajkumar Jaiswal |
| Designation |
MD Scholar |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Department of kriya sharir MAMS Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8208724265 |
| Fax |
|
| Email |
rajjaiswal262@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranita joshi |
| Designation |
Hod |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Department of kriya sharir MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9822229579 |
| Fax |
|
| Email |
pranitaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajkumar Jaiswal |
| Designation |
MD Scholar |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Department of kriya sharir MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8208724265 |
| Fax |
|
| Email |
rajjaiswal262@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of kriya sharir MAMs Sumatibhai shah Ayurved Mahavidyalaya Hadapsar pune pin-411028 Maharshtra india |
|
|
Primary Sponsor
|
| Name |
Dr Rajkumar S Jaiswal |
| Address |
Department of kriya sharir MAMS Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune pin-411028 Maharshtra india |
| Type of Sponsor |
Other [(Principal Investigator 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 Rajkumar jaiswal |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Sane Gurui Aroya Kendra Hadapsar |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Sane Gurui Aroya Kendra Bulding ,Opd no 2 Malwadi Hadapsar Pune 411028
Pune
MAHARASHTRA |
8208724265
rajjaiswal262@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Sane Gurui Aroya Kendra Malwadi Hadapsar Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy individuals and Volunteer having sleep less than 5 hrs |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Yog nidra | (Procedure Reference: Bihar School of yoga, munger bihar, Procedure details: After obtaining a formal permission from the person,self introduction will be given & the purpose of study will be explained.
Recorded audio clip of Yog nidra session 30 minutes daily for 3 days in a week for 1 month)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Apparently healthy individuals will be included in the study of age between 20-35, Volunteer willing for participation in the project, Volunteer having sleep less than 5 hrs, Youth having deprived sleep cycle more than 6 months |
|
| ExclusionCriteria |
| Details |
Volunteer not willing to participate in the study, volunteer having major disease or chronic illness or have undergone major surgery or having any complications , Volunteer who does not have deprived sleep cycle, Volunteer having Diabetes, congenital heart disease or any chronic disease or on any medications are excluded |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Observe the status of raja guna in sleep deprived working young professional |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the effect of yog nidra adminstered in 1 month on rajas guna in sleep deprived working young professional |
1 month |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
07/07/2025 |
| 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="2"
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
|
This is an Clinical Study to asses the Status of raja guna in sleep deprived working young professional. In this study Apparently healthy individual having sleep less than 5 hrs for 6 month will be included and their status of raja guna will be assessed and along with Yog nidra Will be given. |