| CTRI Number |
CTRI/2024/10/075205 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to find out the effect of ujjayi and bhramari pranayama on voice quality of learning singers. |
|
Scientific Title of Study
|
A clinical trial to evaluate the effect of ujjayi and bhramari pranayama on voice quality of prospective vocalist. |
| 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 B M S V Maheshwari |
| Designation |
Pg scholar |
| Affiliation |
Sri dharmasthala manjunatheshwara collage of ayurveda hospital and research center kuthpady udupi |
| Address |
Department of P.G studies in swathavritta sri dharmasthala manjunatheshwara collage of ayurveda hospital and research center kuthpady udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8123855666 |
| Fax |
|
| Email |
maheshwaribm1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay B Negalur |
| Designation |
Head of deparment |
| Affiliation |
Sri dharmasthala manjunatheshwara collage of ayurveda hospital and research center kuthpady udupi |
| Address |
Department of P.G studies in swathavritta sri dharmasthala manjunatheshwara collage of ayurveda hospital and research center kuthpady udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9480046879 |
| Fax |
|
| Email |
drvijaynegalur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay B Negalur |
| Designation |
Head of deparment |
| Affiliation |
Sri dharmasthala manjunatheshwara collage of ayurveda hospital and research center kuthpady udupi |
| Address |
Department of P.G studies in swathavritta sri dharmasthala manjunatheshwara collage of ayurveda hospital and research center kuthpady udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9480046879 |
| Fax |
|
| Email |
drvijaynegalur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri dharmasthala manjunatheshwara collage of ayurveda hospital and research center kuthpady udupi karnataka india 574118 |
|
|
Primary Sponsor
|
| Name |
Dr B M S V Maheshwari |
| Address |
sri dharmasthala manjunatheshwara collage of ayurveda hospital and research center kuthpady udupi karnataka india 574118 |
| 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 B M S V Maheshwari |
Sri dharmasthala manjunatheshwara collage of ayurveda hospital and research center kuthpady udupi |
Department of P.G studies in swathavritta sri dharmasthala manjunatheshwara collage of ayurveda hospital and research center kuthpady udupi
Udupi
KARNATAKA |
8123855666
maheshwaribm1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE-HUMAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:yoga and pranayama(Ujjayi pranayama and Bhramari pranayama will be demonstrated each 9 cycles of early morning practice for 30 days) , Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects are selected irrespective of gender for the study.
2.Prospective vocalist with less than one year of singing practice.
3.Native speakers of kannada.
4.Age 20 to 35 years. |
|
| ExclusionCriteria |
| Details |
1.Known case of chronic respiratory disorders.
2.Hearing disorders.
3.Acute and chronic vocal disorders.
4.Any systemic illness which interferes the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the voice quality of prospective vocalist
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
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)
|
01/11/2024 |
| 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
|
This study is a clinical trail to evaluate the effect of Ujjayi and Bhramari pranayama on voice quality of prospective 30 healthy vocalist. The voice of the 30 healthy vocalists will be assessed using PRAAT , CSL and VOXplot software with standard vocal tasks on day 0 of the study by maintaing all the standard operative procedures of voice recording. Ujjayi pranayama and Bhramari pranayama will be demonstrated each 9 cycles of early morning practice advised for 30 days (from day 1 to day 30). On Day 30, after the practice the voice will be re-recorded with same vocal tasks and standard operative procedures being maintained. The recorded voice samples were saved in the WAV format and were subjected for voice analysis using software PRAAT, CSL and VOXplot at All India Institute of Speech and Hearing center, Mysuru .The study will be conducted at sri dharmasthala manjunatheshwara college of ayurveda, hospital and research center, Kuthpady, Udupi, India. The primary outcome measures will be assessed based on improvement in the voice quality of prospective vocalist by changes in objective parameters like mean fundamental frequency of phonation and speech, fundamental frequency range, jitter, shimmer, HNR, NHR, measurement of long term average speech spectrum(LTAS), singing power ratio, acoustic voice quality index(AVQI) from PRAAT, CSL and VOXplot software ,Improvement in subjective parameters like GRBAS scale, Improvement in perceived phonatory effort(PPE),perceived vocal tiredness(PVT),vocal tract discomfort scale (VTDS). Hence an effort has been planned through this clinical trail to evaluate the effect of ujjayi and bhramari pranayama on voice quality of prospective vocalist. |