| CTRI Number |
CTRI/2025/07/090237 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of Kanthya Dashemani Churna on
voice quality of Student Singers. |
|
Scientific Title of Study
|
A crossover study to assess the effect of Kanthya Dashemani on the quality of voice in Student Singers. |
| 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 Sonal Mansing Bankar |
| Designation |
PG Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Shalakya Tantra, OPD 3 , Amrita School of Ayurveda, P/O Clappana,Near Vallikkavu Junction
Dist - Kollam
Kollam
KERALA
690525
India |
| Phone |
9850545924 |
| Fax |
|
| Email |
sonalbankar8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K shanti |
| Designation |
Assistant Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Shalakya Tantra, OPD 3, Amrita School of Ayurveda, P/O Clappana,Near Vallikkavu Junction
Dist - Kollam
Kollam
KERALA
690525
India |
| Phone |
9544431891 |
| Fax |
|
| Email |
dr.shantik@ay.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Mansing Bankar |
| Designation |
PG Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
OPD No 3, Department of Shalakya Tantra, Amrita School of Ayurveda, P/O Clappana,Near Vallikkavu Junction
Dist - Kollam
Kollam
KERALA
690525
India |
| Phone |
9850545924 |
| Fax |
|
| Email |
sonalbankar8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda, P/O Clappana, Dist - Kollam, Kerala - India
690525 |
|
|
Primary Sponsor
|
| Name |
Dr Sonal Mansing Bankar |
| Address |
Amrita School of Ayurveda, P/O Clappana, Dist - Kollam, Kerala - India
690525 |
| 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 Sonal Mansing Bankar |
OPD No. 03 (Department of Shalakya Tantra) |
OPD No. 03, Department of Shalakya Tantra, Amrita School of Ayurveda, P/O Clappana, Dist - Kollam, Kerala 690525
Kollam
KERALA |
9850545924
sonalbankar8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Student Singers of both genders within the age group of 18 to 30 years, who sings daily or occasionally without any diagnosed voice disorder.
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kanthya Dashemani Churna, Reference: Charaka Samhita Sutrasthana Chapter number 4 Shloka number 9, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: - | | 2 | Comparator Arm | Procedure | - | Gargling | (Procedure Reference: Ashtanga Hridaya Sutrasthana Chapter number 5 Shloka number 16, Procedure details: Warm Water Gargling Twice daily after food for 15 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Student Singers who sings daily or occasionally without any diagnosed voice disorder and feel voice fatigue after singing.
2. Participants of both genders having GRBAS score in between 36 to 50. |
|
| ExclusionCriteria |
| Details |
1. Participants had past history of neurological or pulmonary disease, head & neck surgery.
2. Participants with smoking or hearing complaints according to questionnaires.
3. Participants who reported cold or allergic respiratory conditions on the day of collection of voice sample.
4. Participants who were unable to perform the emission required to the recording of their voices will also be excluded from the study.
5. Professional singers
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in voice fatigue after the administration of kanthya dashemani churna. |
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective parameters and objective parameters like fundamental frequency, Jitter, shimmer & Hormonic to Noise Ratio (HNR) after the administration of kanthya dashemani churna. |
15 Days |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 3 |
|
Date of First Enrollment (India)
|
07/07/2025 |
| 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 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 crossover trial for comparing and generate efficacy of kanthya dashemani churna on quality of voice in student singers age between 18 to 30 years measured with objective parameters like fundamental frequency (FO), Jitter, Shimmer & Hormonic Noise ratio (HNR) through PRAAT software within 15 days. For comparing warm water gargle will be intervene. Study will be conducted in Department of Shalakya Tantra (Amrita School of ayurveda). Before trial, subjective and objective parameters will be assessed and recorded in case record form. Participants will be grouped into Group A and Group B of 44 participants each (22 Males & 22 Females). Group A will be given Kanthya Dashemani churna and Group B will be advised to do warm water gargle twice daily for 15 days. Then after 1 week of washout period Group A will be advised to do warm water gargle and Group B will be given Kanthya Dashemani Churna twice daily for next 15 days. The primary outcome measures will be improvement in voice fatigue and secondary outcome measures will be improvement in objective parameters like jitter, shimmer, fundamental frequency and hormonic to noise ratio. |