| CTRI Number |
CTRI/2025/09/094939 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of yoga nidra in exam going students anxiety in various manas prakriti |
|
Scientific Title of Study
|
The Effect of Yoga Nidra on Exam Going Students Anxiety in Relation to Manas Prakriti |
| 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 Prabhanshu Gupta |
| Designation |
PhD Scholar kriya sharir department |
| Affiliation |
Bharati Vidyapeeth college of Ayurveda |
| Address |
Screening OPD of kriya Sharir Bharati Vidyapeeth college of Screening Opd Ayurveda Dhankawadi Pune-43
Screening OPD of kriya Sharir
Bharati Vidyapeeth college of Ayurveda Dhankawadi Pune-43
Pune
MAHARASHTRA
411043
India |
| Phone |
7000078165 |
| Fax |
|
| Email |
Prabhanshugupta313@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Ghate |
| Designation |
Associate Professor deapramtent of kriya sharir |
| Affiliation |
Bharati Vidyapeeth college of Ayurveda |
| Address |
Bharati Vidyapeeth college of Ayurveda Dhankawadi Pune-43
Bharati Vidyapeeth college of Ayurveda Dhankawadi Pune-43
Pune
MAHARASHTRA
411043
India |
| Phone |
7276862884 |
| Fax |
|
| Email |
umesh.ghate@bharatividhyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabhanshu Gupta |
| Designation |
PhD Scholar |
| Affiliation |
Bharati Vidyapeeth college of Ayurveda |
| Address |
Bharati Vidyapeeth college of Ayurveda Dhankawadi Pune-43
Bharati Vidyapeeth college of Ayurveda Dhankawadi Pune-43
Pune
MAHARASHTRA
411943
India |
| Phone |
7000078165 |
| Fax |
|
| Email |
Prabhanshugupta313@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidhyapeeth college of ayurved Pune-043 |
|
|
Primary Sponsor
|
| Name |
DrPrabhanshu Gupta |
| Address |
Bharati Vidyapeeth (Deemed To Be University), College of Ayurveda, Pune-Satara Road, Dhanakwadi, Pune-43 |
| 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 Prabhanshu Gupta |
Bharati Vidyapeeth Ayurved hospital Pune -83 |
Screening OPD kriya sharir department Bharati Vidyapeeth Ayurved hospital Pune -83
Pune
MAHARASHTRA |
7000078165
Prabhanshugupta313@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Moderate and severe anxiety individuals |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mantra-cikitsA, मन्त्र-चिकित्सा | (Procedure Reference: Kumar K. Yoga nidra and its impact on student’s well being. Yoga Mimamsa. 2004 Apr 1;36:31–5. , Procedure details: Anxiety levels of students will be assessed with the help of Hamilton anxiety scale before Term 1st examination.
Students with moderate & severe anxiety levels (Hamilton anxiety score between 18-56) will be taken 60 days prior to Term 2nd examination & assessment of Manas Prakriti will be done with the help of AYUSOFT C-DAC.
To measure pre interventional physiological indicators of anxiety parameters will be assessed with the help of EEG brain wave pattern, Nadi parameters will be assessed with the help of Nadi tarangini & serum cortisol level will be assessed by collecting blood sample.
They will be suggested to practice yoga nidra with the given audio clip for 30 minutes at 8:30-9:00 am for 15 days.
After completion of the intervention, reassessment will be done using AYUSOFT C-DAC Hamilton Anxiety Scale, EEG, Nadi Tarangini & Serum Cortisol Level within the next week.
Follow up was taken on 30th day.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Students appearing for term examination will be recruited for the study.
volunteers with moderate to severe anxiety levels (hamilton anxiety scale between 18-56). |
|
| ExclusionCriteria |
| Details |
individuals with previous history of psychological illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Yoga Nodra will Reduce hamilton anxiety scores. |
Anxiety levels of students will be assessed with the help of Hamilton anxiety scale before Term 1st examination.
• Students with moderate and severe anxiety levels (Hamilton anxiety score between 18-56) will be taken 60 days prior to Term 2nd examination and assessment of Manas Prakriti will be done with the help of AYUSOFT C-DAC.
To measure pre interventional physiological indicators of anxiety parameters will be assessed with the help of EEG brain wave pattern, Nadi parameters will be assessed with the help of Nadi tarangini and serum cortisol level will be assessed by collecting blood sample.
After completion of the intervention, reassessment will be done using AYUSOFT C-DAC Hamilton Anxiety Scale, EEG, Nadi Tarangini and Serum Cortisol Level within the next week.
Follow up was taken on 30th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Improvement in anxiety associated symptoms as described in classical Ayurvedic texts.
• Nadi Tarangini Parameters: Improved Nadi characteristics suggesting better autonomic balance & reduced physiological stress responses after Yoga Nidra.
• Serum Cortisol Levels: Significant reduction in serum cortisol, indicating decreased stress levels after consistent Yoga Nidra practice
• Academic Performance: Improved concentration, cognitive function, & academic scores observed, particularly in students with reduced anxiety.
• Positive correlation between reduced anxiety & improved academic outcomes.
• Yoga Nidra is expected to promote Satva while reducing Rajas–Tamas, thereby alleviating anxiety, enhancing resilience, & stabilizing EEG, Nadi Tarangini, & cortisol levels.
|
AFTER 30 days reassesment will be done |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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)
|
01/10/2025 |
| 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
Modification(s)
|
Years="3"
Months="0"
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
|
· Anxiety levels of students will be assessed with the help of Hamilton anxiety scale before Term 1st examination. · Students with moderate and severe anxiety levels (Hamilton anxiety score between 18-56) will be taken 60 days prior to Term 2nd examination and assessment of Manas Prakriti will be done with the help of AYUSOFT C-DAC. To measure pre interventional physiological indicators of anxiety parameters will be assessed with the help of EEG brain wave pattern, Nadi parameters will be assessed with the help of Nadi tarangini and serum cortisol level will be assessed by collecting blood sample. Practice yoga nidra with the given audio clip for 30 minutes at 8:30-9:00 am for 15 days
After completion of the intervention, reassessment will be done using AYUSOFT C-DAC Hamilton Anxiety Scale, EEG, Nadi Tarangini and Serum Cortisol Level within the next week.
|