| CTRI Number |
CTRI/2022/09/045983 [Registered on: 28/09/2022] Trial Registered Prospectively |
| Last Modified On: |
11/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to validate smart breath analyzer as a screening tool for diabetic, hepatic, renal, lung, lipid and other
metabolic disorders |
|
Scientific Title of Study
|
Early identification of metabolic function derangements such as diabetes, liver, renal issues by Humors’ smart breath analyzer and its validation as a screening tool among diseased and healthy controls |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suchita Kanaldekar |
| Designation |
Chief Scientific Officer |
| Affiliation |
Humors Tech Pvt Ltd. |
| Address |
Humors Tech
#60, 3rd Floor Wind Nal Tunnel Road, Murugeshpalya, Bangalore. 560017. Karnataka
#60, 3rd Floor Wind Nal Tunnel Road, Murugeshpalya, Bangalore. 560017. Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
|
| Fax |
|
| Email |
suchita@humorstech.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suchita Kanaldekar |
| Designation |
Chief Scientific Officer |
| Affiliation |
Humors Tech Pvt Ltd. |
| Address |
Humors Tech
#60, 3rd Floor Wind Nal Tunnel Road, Murugeshpalya, Bangalore. 560017. Karnataka
#60, 3rd Floor Wind Nal Tunnel Road, Murugeshpalya, Bangalore. 560017. Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
|
| Fax |
|
| Email |
suchita@humorstech.com |
|
Details of Contact Person
Public Query
|
| Name |
Suchita Kanaldekar |
| Designation |
Chief Scientific Officer |
| Affiliation |
Humors Tech Pvt Ltd. |
| Address |
Humors Tech
#60, 3rd Floor Wind Nal Tunnel Road, Murugeshpalya, Bangalore. 560017. Karnataka
#60, 3rd Floor Wind Nal Tunnel Road, Murugeshpalya, Bangalore. 560017. Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
|
| Fax |
|
| Email |
suchita@humorstech.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Humors Tech Pvt Ltd |
| Address |
Humors Tech Pvt Ltd
#60, 3rd Floor Wind Nal Tunnel Road, Murugeshpalya, Bangalore - 560017 Karnataka |
| Type of Sponsor |
Other [Health Technology Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ambanna Gowda |
Citizen Hospital |
#14, 2n main, Dispensary Road,
Kalasipalya, Bangalore 560002
Bangalore
KARNATAKA |
9845270377
dr.ambanagowda@gmail.com |
| Dr Vishal Gupta |
Dr. Vishal Gupta Clinic |
Dr. Vishals Clinic, 101/1 Patel Marg, Jaipur
Jaipur
RAJASTHAN |
9001468743
abhilashasuwalka@gmail.com |
| Dr Manoj Kumar Singh |
Flores Hospital |
G350, Pratap Vihar Rd., G Block
Sector-11 Pratap Vihar, Ghaziabad ,
Uttar Pradesh-201009
Ghaziabad
UTTAR PRADESH |
9825469717
manojsinghdr@gmail.com |
| Dr Shashi Prakash Maurya |
Human Care Hospital |
1B, Kanpur Rd. Barigawa Rd, Near
Phoenix Mall, Lucknow, Uttar Pradesh-
226012, India.
Lucknow
UTTAR PRADESH |
9415005158
drspmauryaa@gmail.com |
| Dr Nayanabai Shabadi |
JSS Hospital and Medical College |
Dept. of Community
Medicine, JSS Medical
College, S.S.Nagar,
Bannimantap, Mysuru –
570 015.
Mysore
KARNATAKA
Mysore
KARNATAKA |
8105828888
nayanabaishabadi@jssuni.edu.in |
| Dr Harsh Mittal |
Panchsheel Hospital Pvt. Ltd. |
C-3/63-A,64-A, Yamuna Vihar, Delhi-110053
North East
DELHI |
9560506410
harshmittal86@gmail.com |
| Dr Santosh Saklecha |
Santosh Hospital |
6/1,Promenade Rd, Near Coles Park, Frazer Town, Bengaluru, Karnataka 560005
Bangalore
KARNATAKA |
9845306703
ssaklecha@gmail.com |
| Dr Dipti Gupta |
Tulsi Multispecialty Hospital |
B-1, Loni Rd., West Jyoti Nagar,
Shahdara, Delhi-110094
North East
DELHI |
9811676049
drdipti16@gmail.com |
| Dr Meghana Murthy |
Vagus Super Speciality Hospital |
6, 7 & 8. 18th Cross, 4th Main Rd., Malleswaram, Bengaluru-560055
Bangalore
KARNATAKA |
7259214727
meggydoc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Panchsheel Hospital Ethics Committee |
Approved |
| Royal Pune Independent Ethics Comittee, Office No. 13, Srv. No. 81/A, Anupam Arcade, Opposite Snake Park, Katraj, Pune, Maharashtra - 411046 India |
Approved |
| Santosh Hospital-Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
None |
| Patients |
(1) ICD-10 Condition: E888||Other specified metabolic disorders, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participant must either be a completely healthy individual as confirmed by blood examination or a known case of diseases in focus such as diabetes, kidney issue, liver issue, lung issue and lipid issue with relevant diagnostics reports tested within 15 days of participation in the study.
a. Patients that are known case of Diabetes tested for FBS or RBS within 15 days of participation
b. Patients that are known case of kidney related disease tested for RFT within 15 days of participation
c. Patients that are known case of liver related disease tested for LFT within 15 days of participation
d. Patients that are known case of lung related disease tested by spirometry within 15 days of participation
e. Patients that are known case of lipid related disease tested for lipid profile within 15 days of participation.
2. All genders, ethnicity
3. Age Group: 18 to 75years
4. Participant who has given informed consent for participating in this study
5. Participant must be fully vaccinated for COVID
6. Participant must use smart breath analyzer at fasting condition. If not fasting, there should be a minimum gap of 1 hour between consuming water and testing, and 3-4 hours between consuming food and testing. |
|
| ExclusionCriteria |
| Details |
1. Individual less than 18 or above 75years of age
2. Pregnant and lactating females
3. Known case of ongoing illness such as
a. Cancer
b. AIDS
c. COVID
d. Cough, Fever
e. TB
f. Chickenpox
g. Influenza
h. Mumps
i. Tonsil
4. Individual who has not given informed consent for this study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Development and validation of IoT & Deep tech enabled smart breath analyzer for accurate and early screening of metabolic derangements such as diabetes, kidney issues, liver issues lung and lipid issues.
2. AI and ML based affordable, non-invasive and effective option for prophylaxis and healthcare.
3. Effective and early screening of underlying health issues in an individual to enable timely preventive action. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Measurement of Total cholesterol
Triglycerides
HDL
VLDL
LDL
Cholesterol/ HDL Ratio
LDL/HDL Ratio
Liver Function
Kidney Function
Blood sugar
and compare with levels of critical compounds
measured by smart breath analyzer device. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
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)
|
03/10/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, multicentric, non-treatment study to build and validate a portable, non-invasive smart breath analyzer that can screen underlying health issues using exhaled breath. The study will be conducted with healthy participants and participants with known cases of diabetes, kidney related issues, liver related issues, lung related issues and lipid related issues as confirmed by pathology reports. In phase 1, 500 apparently healthy individuals with normal levels of fasting and postprandial blood sugar, renal function test, liver function test, lung function test and lipid profile will be recruited in the study. In phase 2 of the study, 500 patients of type 2 diabetes, liver function, renal function, lung function and lipid profile derangements each diagnosed by 10% increment above the normal values will be enrolled. In phase 3 of the study, validation of breath analyzer as a screening tool for early identification of type 2 diabetes, liver, renal, lung, lipid and other metabolic function derangements will be done by randomly assigning healthy and diseased participants for exhaled breath sample analysis with estimation of levels of various compounds present in the given breath sample. This innovative study will be based on principle of exhaled breath analysis where parts per million and parts per billion level of volatile organic compounds and gases present in a human’s breath will be measured. Further powerful AI based algorithms will be generated that can effectively screen unhealthy biomarker levels in an individual, enabling timely preventive action to manage underlying health issues. |