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CTRI Number  CTRI/2018/08/015237 [Registered on: 08/08/2018] Trial Registered Prospectively
Last Modified On: 19/11/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Device validation study 
Study Design  Other 
Public Title of Study   A clinical validation of respiratory medical device and its correlation with clinical tests and diagnosis 
Scientific Title of Study   Respiratory sound analysis and correlation with clinical tests and clinical diagnosis 
Trial Acronym  Salcit Study 
Secondary IDs if Any  
Secondary ID  Identifier 
SALCIT/2018/001  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sai Praveen Haranath 
Designation  Consultant Intensivist and Consultant Pulmonologist 
Affiliation  Apollo Hospitals 
Address  Apollo Hospitals Jubilee Hills Hyderabad

Hyderabad
ANDHRA PRADESH
500096
India 
Phone    
Fax    
Email  indialungdoc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Narayana Rao Sripada 
Designation  Chief Executive Officer 
Affiliation  SALCIT TECHNOLOGIES PRIVATE LIMITED 
Address  Flat No 2408 Sai Dream Castle Apartment Nizampet Road KUKATPALLY Hyderabad Telangana

Hyderabad
ANDHRA PRADESH
500090
India 
Phone  919945399533  
Fax    
Email  svnnrao@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Narayana Rao Sripada 
Designation  Chief Executive Officer 
Affiliation  SALCIT TECHNOLOGIES PRIVATE LIMITED 
Address  Flat No 2408 Sai Dream Castle Apartment Nizampet Road KUKATPALLY Hyderabad Telangana

Hyderabad
ANDHRA PRADESH
500090
India 
Phone  919945399533  
Fax    
Email  svnnrao@gmail.com  
 
Source of Monetary or Material Support  
SALCIT TECHNOLOGIES PRIVATE LIMITED, Flat No 2408, Sai Dream Castle Apartment, Nizampet Road,KUKATPALLY, Hyderabad, Telangana, 500090 
 
Primary Sponsor  
Name  SALCIT TECHNOLOGIES PRIVATE LIMITED 
Address  Flat No 2408, Sai Dream Castle Apartment, Nizampet Road,KUKATPALLY, Hyderabad, Telangana, 500090 
Type of Sponsor  Other [IT COMPANY WHICH IS INTO HEALTH CARE SERVICES] 
 
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 Sai Praveen Haranath  Apollo Hospital  Room No 9054, Pulmonology Department, Basement 01, Main block, Apollo Hospitals, Jubilee Hills
Hyderabad
ANDHRA PRADESH 
919866415551

indialungdoc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-Clinical Studies (IEC-CS)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Written signed and dated informed consent (patient or LAR)
2. Either gender with age 18 years and above.
3. Subjects suffering with CRD’s, Pulmonary Tuberculosis, CHF and Pulmonary Fibrosis.  
 
ExclusionCriteria 
Details  1. Subjects who require ventilation, flow of oxygen must be excluded from the study.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Test the hypothesis that the sound characteristics differ for various CRDs. Sound characteristics can be used in determining severity of inflammation.
2.Test the hypothesis that sound characteristics have correlation with clinical test like spirometry and associated parameters, bed side lung function tests and clinical diagnosis. 
For each subject minimum of 5 records are required for in-patients.
2 records on the first and second day of admission.
2 records during course of treatment (after first or second day and prior to discharge)
1 record during discharge (or during stable state)
For each outpatient a minimum of 2 records will be attempted.

 
 
Secondary Outcome  
Outcome  TimePoints 
Test the hypothesis that sound characteristics have correlation with clinical test like spirometry and associated parameters, bed side lung function tests and clinical diagnosis.  For each subject minimum of 5 records are required for in-patients.
2 records on the first and second day of admission.
2 records during course of treatment (after first or second day and prior to discharge)
1 record during discharge (or during stable state)
For each outpatient a minimum of 2 records will be attempted. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/09/2018 
Date of Study Completion (India) 09/07/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a validation study to analyze the data delivered by the study device and correlate with clinical tests and diagnosis. This study will analyze the respiratory sounds characteristics of the patients suffering from various chronic respiratory diseases, pulmonary tuberculosis, and congestive heart failure. 
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