| CTRI Number |
CTRI/2025/05/087443 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [music therapy] |
| Study Design |
Other |
|
Public Title of Study
|
This study aims to develop and test an Indian music therapy module to manage Kapha imbalance |
|
Scientific Title of Study
|
Development and feasibility of Indian music therapy module for kapha imbalance |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
LAKSHMI SURENDRAN |
| Designation |
PHD SCHOLAR |
| Affiliation |
Swami Vivekanand Yoga Anusandhana Samsthana University |
| Address |
941/G, 4th floor, BTM 4th stage, 2nd Block, Bengaluru
Swami Vivekanand Yoga Anusandhana Samsthana University
Yoga and Humanities
Arogyadhama 3rd floor,
Kalluballu post, anekal, swami vivekanda rd, jignai, Karnataka 560105
Bangalore
KARNATAKA
560076
India |
| Phone |
08088340415 |
| Fax |
|
| Email |
lakshmisurendran73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Karuna Nagarajan |
| Designation |
Associate Professor |
| Affiliation |
Swami vivekanada yoga anusandhana samthana UNIVERSITY |
| Address |
Swami vivekanada yoga anusandhana samthana University, Yoga and Humanities dept.,
Kallubalu Post, Jigani, Bengaluru
Arogyadhama building
Yoga and Humanities dept.,Kalluballu post, anekal, swami vivekanda rd, jignai, Karnataka 560105
Bangalore
KARNATAKA
560105
India |
| Phone |
9740499958 |
| Fax |
|
| Email |
karuna.nagarajan@svyasa.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
LAKSHMI SURENDRAN |
| Designation |
PHD SCHOLAR |
| Affiliation |
Swami vivekanada yoga anusandhana samsthana UNIVERSITY |
| Address |
941/G, 4th floor, BTM 4th tsage, 2nd Block, bengaluru
Swami vivekanada yoga anusandhana samsthana UNIVERSITY, yoga and humanities dept,
arogyadhama,
Kalluballu post, anekal, swami vivekanda rd, jignai, Karnataka 560105
Bangalore
KARNATAKA
560076
India |
| Phone |
08088340415 |
| Fax |
|
| Email |
lakshmisurendran73@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swami vivekananda yoga anusandhana samsthana
university,
Kalluballu Post, Anekal, Swami Vivekananda Rd, Jigani, Karnataka, India 560105 |
|
|
Primary Sponsor
|
| Name |
LAKSHMI SURENDRAN |
| Address |
941/G , 4TH floor, btm 4th stage, 2nd block, bangalore
Karnataka, India 560076 |
| Type of Sponsor |
Other [Self-Funded] |
|
|
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 Karuna Nagarajan |
swami vivekanada yoga anusandhana samsthana university |
swami vivekanada yoga anusandhana samsthana university, Yoga and Humanities dept,
Kallubalu post, jigani, 560105
Bangalore
KARNATAKA |
9740499958
karuna.nagarajan@svyasa.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional ethics committee of swami Vivekanada Yoga Anusandhana Samsthana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MUSIC THERAPY |
The validated music therapy module will be used in this study, where the 60 participants will be randomly allotted to Group A (Music) and Group B (Control), for 6 weeks. The music group participants will be given to listen a validated music therapy module for 15 minutes for 4 times in a day (60 minutes). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Women diagnosed with PCOS |
|
| ExclusionCriteria |
| Details |
Other age group
Participants with hearing impairment
Participants already enrolled in any music program
Inability to speak or understand the English language
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kapha Dosha |
Baseline, after 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Predominance in the Kapha Dosha
|
baseline |
| Self-Esteem |
baseline, After 6 weeks |
| music receptivity |
baseline, After 6 weeks |
| PCOS symptom change |
Baseline, After 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/05/2025 |
| 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="5"
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
Modification(s)
|
To assess the feasibility of the validated music therapy module through a randomized controlled trial using a few questionnaires on polycystic ovarian syndrome participants, which is one of the diseases caused by Kapha imbalance. The developed and validated music therapy module may balance Kapha Dosa disrupting women’s health. |