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CTRI Number  CTRI/2023/11/059699 [Registered on: 09/11/2023] Trial Registered Prospectively
Last Modified On: 08/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Administration of medicated oil as nasal drops to assess the improvement in voice quality of singers. 
Scientific Title of Study   A Randomized controlled clinical trial to assess the effect of Snehana Nasya on voice parameters of 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.Athira Venugopal 
Designation  PG Scholar 
Affiliation  Rajiv Gandhi University ofHealth Science,Bangalore 
Address  Department of PG Studies in Panchakarma, 3rd Floor,Room no 4 Alvas Ayurveda Medical College Vidyagiri, Moodbidri

Dakshina Kannada
KARNATAKA
574227
India 
Phone  8970695299  
Fax    
Email  athirapalliyath@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Rohini purohit 
Designation  Assisstant Professor MD.AYU 
Affiliation  Rajiv Gandhi University of Health Sciences Bangalore 
Address  Department of PG Studies in Panchakarma, 3rd Floor,Room no 4 Alvas Ayurveda Medical College Vidyagiri, Moodbidri

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9481845928  
Fax    
Email  dr.rohiniayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.Athira Venugopal 
Designation  PG Scholar 
Affiliation  Rajiv Gandhi University of Heath Sciences Banglore 
Address  Department of PG Studies in Panchakarma, 3rd Floor,Room no 4 Alvas Ayurveda Medical College Vidyagiri, Moodbidri

Dakshina Kannada
KARNATAKA
574227
India 
Phone  8970695299  
Fax    
Email  athirapalliyath@gmail.com  
 
Source of Monetary or Material Support  
Department of PG Studies in Panchakarma, 3rd Floor,Room no 4 Alvas Ayurveda Medical College Vidyagiri, Moodbidri  
 
Primary Sponsor  
Name  DrAthira Venugopal 
Address  Department of PG Studies in Panchakarma 3rd Floor Room no 4 Alvas Ayurveda Medical College Vidyagiri, Moodbidri  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Athira Venugopal  Alvas Ayurveda Medical College and Hospital   Department of PG Studies in Panchakarma, 3rd Floor,Room no 4
Dakshina Kannada
KARNATAKA 		 8970695299

athirapalliyath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Clinical Ethics Committee Alvas Ayurveda Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy female singers Swastha 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-aBya~ggaH अ"ंग svedanam eेदनम् nasyam/ nastam नUम्/ नFम kavalaH कवल dhUmapAnam धूमपानम (Procedure Reference: Ashtangahridaya, Procedure details: The subject should have to lie down in supine position.Face massage is done with ksheerabala thaila & swedana(sudation) is done. 4 ml of lukewarm Ksheerabala thaila is to be taken in a gokarna & instilled to each nostrils one after the other. After treatment medicated smoke inhalation is done.Patient is made to wash hands & face in leukewarm water.))
(1) Medicine Name: Ksheerabala taila, Reference: Ashtangahridaya, Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Duration: 7 Days
2Comparator ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:no intervention.only song practice will be doing in both group., Pathya/Apathya:, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Singers who had training for atleast 1 year.
2.Individuals not suffering from systemic disease.
3.Individuals who are fit for the treatment  
 
ExclusionCriteria 
Details  1. Individuals suffering from systemic illness.
2.Professional singers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Betterment of voice parameters
2. Evaluate the effect of medicated nasal drops 		 treatment done for 7 days. Assessment is done on 0th 8th 15th 22nd 28th day 
 
Secondary Outcome  
Outcome  TimePoints 
1. betterment in cepstral analysis.
2. improvement in peak flow rate 		 22nd and 28th day 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/11/2023 
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   It is a randomized controlled clinical trial to essess the effect of  Snehana Nasya (medicated nasal drops) on voice parameters of singers.60 healthy female singers are divided into 2 equal groups. One interventional group and one controll group(where no treatment done) .7 days of treatment is done and assessment is done on 0th day(before treatment), 8th day ,15th day, 22nd day, 28th day.Trial will be done at  OPD of Alvas Ayurveda Medical College, moodbidri. 
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