| CTRI Number |
CTRI/2024/12/078486 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of listening classical music on serum total cholesterol, serum cortisol and blood sugar level in healthy young adults. |
|
Scientific Title of Study
|
A study of serum total cholesterol, serum cortisol and blood sugar level changes after listening classical music in 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 |
Ahmad Sameer Khan |
| Designation |
Junior Resident |
| Affiliation |
G.S.V.M. Medical College, KANPUR. |
| Address |
Department of Physiology,
G.S.V.M. Medical College, Kanpur.
208002 Uttar Pradesh, India.
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7985695765 |
| Fax |
|
| Email |
ask.ask397@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jalaj Saxena |
| Designation |
Professor |
| Affiliation |
G.S.V.M. Medical College, Kanpur |
| Address |
Department of Physiology,
G.S.V.M. Medical College, Kanpur .
208002, Uttar Pradesh India.
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9450131597 |
| Fax |
|
| Email |
drjalajsaxena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jalaj Saxena |
| Designation |
Professor |
| Affiliation |
G.S.V.M. Medical College, Kanpur. |
| Address |
Department of Physiology,
G.S.V.M. Medical College,Kanpur
208002 Uttar Pradesh, India.
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9450131597 |
| Fax |
|
| Email |
drjalajsaxena@gmail.com |
|
|
Source of Monetary or Material Support
|
| G.S.V.M. Medical College, Kanpur. |
|
|
Primary Sponsor
|
| Name |
Ahmad Sameer Khan |
| Address |
Department of Physiology, G.S.V.M. Medical College, Kanpur. 208002 Uttar Pradesh, India. |
| 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 |
| Ahmad Sameer Khan |
G.S.V.M. Medical College Kanpur 208002. Uttar Pradesh, India. |
Room number 1, Haematology laboratory, Department of Physiology.
Kanpur Nagar
UTTAR PRADESH |
07985695765
ask.ask397@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical College Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Young adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Music will not played for the control group |
| Intervention |
Double arm study with control group |
Indian classical music (Rag todi) will be played for 20 minutes for 6 days in a week for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Healthy male and female participants with age between 18 - 25 years |
|
| ExclusionCriteria |
| Details |
Any known chronic disease
History of any kind of hormonal intake
Participants on any type of long medication
Participants with any known hearing loss
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Indian classical music (Rag todi) on the serum cholesterol, serum cortisol and blood sugar levels. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of Indian classical music (Rag todi) on anxiety( STAI scale) |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
31/01/2025 |
| 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="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
|
This study is aim to see the effect of Indian classical music ( Rag Todi) on serum total cholesterol, serum cortisol and blood sugar level changes. Also see the effect of Indian classical music (Rag todi) on anxiety (STAI scale ) |