| CTRI Number |
CTRI/2025/04/085248 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
19/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Raga Therapy] |
| Study Design |
Other |
|
Public Title of Study
|
Benefits Of Indian Classical Ragas On , Blood Pressure, And Reaction Time in Adults. |
|
Scientific Title of Study
|
Impact Of Indian Classical Ragas On Heart Rate, Blood Pressure, And Audio-Visual Reaction Time on Young Adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aryan Malaviya |
| Designation |
MBBS Student |
| Affiliation |
Manipal Tata Medical College |
| Address |
Department of Physiology
Manipal Tata Medical College
Kadani Road, Baridih, Jamshedpur
Purbi Singhbhum JHARKHAND 831017 India |
| Phone |
8318645907 |
| Fax |
|
| Email |
aryanmalaviya26@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
VINAY A V |
| Designation |
Professor |
| Affiliation |
Manipal Tata Medical College |
| Address |
Department of Physiology
Manipal Tata Medical College, Kadani road, Baridih, Jamshedpur
Purbi Singhbhum JHARKHAND 831017 India |
| Phone |
9880966679 |
| Fax |
|
| Email |
vinay.av@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
VINAY A V |
| Designation |
Professor |
| Affiliation |
Manipal Tata Medical College |
| Address |
Department of Physiology
Manipal Tata Medical College, Kadani road, Baridih, Jamshedpur
Purbi Singhbhum JHARKHAND 831017 India |
| Phone |
9880966679 |
| Fax |
|
| Email |
vinay.av@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiology
Manipal Tata Medical College, Jamshedpur, East Singhbhum District, Jharkhand, India-831017 |
|
|
Primary Sponsor
|
| Name |
Aryan Malaviya |
| Address |
Department of Physiology
Manipal Tata Medical College, Kadani road, Baridih, Jamshedpur
East singhbhum district, Jharkhand, India-831017 |
| 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 Vinay A V |
Manipal Tata Medical College |
Department of physiology
Manipal Tata medical College, Kadani Road, Baridih, Jamshedpur Purbi Singhbhum JHARKHAND |
9880966679
vinay.av@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manipal Tata Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Must listen to various Ragas |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Classical Ragas |
Listening to classical Ragas for 10 minutes |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.MBBS Students
2.Age group between 18 to 25 years.
3.Volunteers willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1.Individuals suffering from fever, cough, vomiting, or other illness affecting their daily routine.
2.Individuals with a history of daily alcohol intake, tobacco chewing, and smoking.
3.Individuals on any medications like anti-depressants, antipsychotics, and psychotropic drugs.
4.Individuals suffering with any neurological, psychiatric, CVD, or metabolic diseases
5.Individuals with sleep disturbances and disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Impact of Raga Bhiravi and raga Bhupali on Heart rate and blood pressure and audiovisual reaction time |
Blood Pressure and Audiovisual reaction time will be assessed before and immediately after listening to the classical ragas for 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
04/05/2025 |
| 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="0" Months="6" 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
|
Nature has bestowed upon mankind with innumerable sounds, vibrations and energies. Our Indian Classical Music is one of the byproducts of this gift of nature. Raga is a combination of notes in an ascending or descending order.1 Every raga has a unique essence, feeling(rasa), and emotional content(bhava).2 Listening to the right raga at the right time is said to smoothen the natural transitions and attune the body and mind to the circadian cycle.3 Music has been reported to decrease blood pressure, heart rate (HR), respiration rate, anxiety and pain with improved quality of sleep, pre competition stress in athletes etc. in many research studies.4 The vagus nerve, cranial nerve X, is located near the eardrum and responds to musical vibrations by triggering the body to relax. This pathway may explain the study observations which found lower systolic blood pressure after listening to slow, classical music.5 Reaction time measurement is an indirect index of processing capability of central nervous system and simple means of determining sensory motor association and performance of an individual.6 Cognitive disorders, like Alzheimer’s disease, Attention deficit disorder, Dementia, Epilepsy-related cognitive dysfunction all deals with slow Reaction time. So Indian classical music can be used in disorder that is characterized by perception, information processing, or motor problems. Indian ragas could be a safe alternative for many medical interventions.7 Diverse ragas exhibit varying impacts on our physiological systems, yet this research specifically examines the influence of Raga Bhairavi and Bhupali. In the literature, Raga Bhairavi has been known to induce calmness and spiritual well-being significantly.2 The Raga Bhupali, equivalent to the Lydian mode of Western music instills the shringara rasa or aesthetic mood of love within the listener.3 It is a great raga to bring us back to a calm state.7 Although music is predominantly utilized for religious, enjoyment or entertainment purposes, it is gradually emerging as a promising non-pharmacological intervention for improving health outcomes in both healthy and diseased populations, especially in those with cardiovascular diseases.8 This study was envisioned to assess the impact of classical ragas on cardiovascular and cognitive function, for the probable utilization of these ragas as adjuvant therapy in regulating cardiovascular and cognitive parameters. |