| CTRI Number |
CTRI/2025/10/096546 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
NIL |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of an AI Based Tool for Early Diagnosis and Prediction of Diseases |
|
Scientific Title of Study
|
Clinical Validation Of Cure Catalyst -AI Diagnostic And Predictive Tool |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRBhavana Doshi |
| Designation |
Professor & Head |
| Affiliation |
KLES Dr.Prabhakar Kore Hospital |
| Address |
KLES Dr.Prabhakar Kore Hospital & MRC
Nehru Nagar
Belagavi
J.N.Medical College
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9422306523 |
| Fax |
|
| Email |
bhavs1982@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRBhavana Doshi |
| Designation |
Professor & Head |
| Affiliation |
KLES Dr.Prabhakar Kore Hospital |
| Address |
KLES Dr.Prabhakar Kore Hospital & MRC
Nehru Nagar
Belagavi
J.N.Medical College
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9422306523 |
| Fax |
|
| Email |
bhavs1982@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupinder Kaur |
| Designation |
Chief Medical Officer |
| Affiliation |
Superceuticals Private Limited |
| Address |
Plot No 19
Infocity 2
Sector 33
Gurgaon
Gurgaon
HARYANA
122002
India |
| Phone |
9833001174 |
| Fax |
|
| Email |
drkaur@superceuticals.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Superceuticals Private Ltd |
| Address |
Plot no 19
Infocity2
Sector 33
Gurgaon |
| Type of Sponsor |
Other [Company owned] |
|
|
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 BHAVANA DOSHI |
KLES Dr Prabhakar Kore Hospital And MRC |
KLES DR PRABHAKAR KORE HOSPITAL NEHRU NAGAR
BELGAVI 590010
Belgaum
KARNATAKA |
9422306523
000
bhavs1982@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comitee Of KLE Academy Of Higher Education And Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting the visible dermatological conditions e.g
rashes
lesions
pigmentation disorders
inflammatory and non inflammatory diseases |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic accuracy Sensitivity Specificity Predictive value of cure catalyst AI compared to dermatological assessment |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
10/12/2025 |
| 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="0"
Months="11"
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 clinical study aims to validate the performance of Cure Catalyst ,an AI -powered diagnostic and predictive tool for dermatological conditions .The tool leverages machine learning algorithm to analyze skin images and patient data for accurate and early detection of common dermatological disorders . |