| CTRI Number |
CTRI/2025/08/092281 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Raga Todi and Raga Bhimpalasi on Anxiety in Medical students. |
|
Scientific Title of Study
|
A Comparative study of the Effect of Raga Todi and Raga Bhimpalasi in Anxiety Levels in Medical students. |
| 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 Sneha Shinde |
| Designation |
MD Scholar |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri,Pune-411018 |
| Address |
Department of Kriya Sharir Fourth floor , Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9834190646 |
| Fax |
|
| Email |
vd.snehashinde1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaya Nyahalse |
| Designation |
Associate professor |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri,Pune-411018 |
| Address |
Department of Kriya Sharir Fourth floor, Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7709082385 |
| Fax |
|
| Email |
jiya.nyahalse11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijaya Nyahalse |
| Designation |
Associate professor |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri,Pune-411018 |
| Address |
Department of Kriya Sharir Fourth Floor , Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7709082385 |
| Fax |
|
| Email |
jiya.nyahalse11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd No. 7 , Department of Swasthvritta and yoga , Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune- 411018 |
|
|
Primary Sponsor
|
| Name |
Dr. Sneha Shinde |
| Address |
Dr. D. Y. Patil College of Ayurved and Research Centre,Sant Tukaram Nagar, Pimpri,Pune-411018 |
| 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 Sneha Shinde |
Dr. D. Y. Patil Ayurved Hospital Pimpri, Pune |
Opd No. 7 , Department of Swasthvritta and yoga , Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA |
09834190646
vd.snehashinde1111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intuitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Medical Students having anxiety |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: For Group 2 audio of Raga Bhimpalasi in early afternoon i.e. between 12pm – 3 pm for 15 mins daily for 30 days. , Ritucarya: NIL, Acara Rasayana:NIL, Other:NIL, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: For Group 1 audio of Raga todi in late morning period i.e between 7:00 am - 10:00am for 15 mins daily for 30 days., Ritucarya: NIL, Acara Rasayana:NIL, Other:NIL, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Participants having Minimum score 18 of Anxiety levels as per Hamilton anxiety Scale.
Voluntarily participation in the clinical trial and agreeing to follow study procedures.
|
|
| ExclusionCriteria |
| Details |
Individuals diagnosed with psychiatric disorder.
Taking medications that may alter mental status.
Participants who are already practicing yoga, pranayama, meditation, or any other relaxation techniques.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Raga Todi shows significant effect on reducing Anxiety levels than Raga Bhimpalasi.
Raga Bhimpalasi shows significant effect on reducing Anxiety levels than Raga Todi. |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
23/08/2025 |
| 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="6"
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
|
Selection of participants will be done according to the inclusion criteria. Informed consent will be taken from the participants after giving them proper information about the study. Randomization will be done by lottery method . Baseline Assessment of Anxiety of the participants using Hamilton Anxiety scale will be conducted on the day 0 , before the intervention, to record the initial Anxiety levels. The audio of Raga Todi in late morning period i.e. between 7:00am- 10:00am for Group 1 and Raga Bhimpalasi in early afternoon i.e. between 12:00pm-3:00 pm for Group 2, will be provided to listen to for 15 mins daily for next 30 days. Post assessment of the participants using Hamilton Anxiety scale will be done after 30 days of intervention to evaluate changes in Anxiety levels. Data analysis, Observation, Results and Conclusion will be drawn.
|