| CTRI Number |
CTRI/2025/07/091043 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Diagnosis of Osteoarthritis by using AI |
|
Scientific Title of Study
|
Utilizing Artificial intelligence for diagnostics in Sandhivata (Osteoarthritis) – An Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR JAGDEEP ARYA |
| Designation |
PG SCHOLAR |
| Affiliation |
PT. KHUSHILAL SHARMA GOVT. AYURVEDA COLLEGE AND HOSPITAL BHOPAL |
| Address |
ROG NIDAN DEPARTMENT SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH ROG NIDAN DEPARTMENT SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH Bhopal MADHYA PRADESH 462003 India |
| Phone |
9770842839 |
| Fax |
|
| Email |
jagdeep839sen@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR RITA SINGH |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
PT. KHUSHILAL SHARMA GOVT. AYURVEDA COLLEGE AND HOSPITAL BHOPAL |
| Address |
ROG NIDAN DEPARTMENT SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH ROG NIDAN DEPARTMENT SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH Bhopal MADHYA PRADESH 462003 India |
| Phone |
8435990799 |
| Fax |
|
| Email |
vd.ritu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR JAGDEEP ARYA |
| Designation |
PG SCHOLAR |
| Affiliation |
PT. KHUSHILAL SHARMA GOVT. AYURVEDA COLLEGE AND HOSPITAL BHOPAL |
| Address |
ROG NIDAN DEPARTMENT SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH 462003 ROG NIDAN DEPARTMENT SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL 462003 Bhopal MADHYA PRADESH 462003 India |
| Phone |
9770842839 |
| Fax |
|
| Email |
jagdeep839sen@gmail.com |
|
|
Source of Monetary or Material Support
|
| PT KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE & INSTITUTE BHOPAL MADHYA PRADESH |
|
|
Primary Sponsor
|
| Name |
PT KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE INSTITUTE BHOPAL |
| Address |
ROOM NO 6 ROG NIDAN DEPARTMENT SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH 462003 INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 JAGDEEP ARYA |
PT KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE & INSTITUTE BHOPAL |
ROOM NO 6 ROG NIDAN DEPARTMENT SCIENCE HILLS BEHIND MANIT NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH 462003 INDIA Bhopal MADHYA PRADESH |
9770842839
jagdeep839sen@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 |
OSTEOARTHRITIS OF KNEE |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
41.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants fulfilling the diagnostic criteria.
2.Participants of either sex between the age group of 41 – 70 years.
3.Participants willing to give written informed consent for the participation in the proposed research works. |
|
| ExclusionCriteria |
| Details |
1.Participants not fulfilling the inclusion criteria.
2.Pregnant and lactating women.
3.Participants suffering from serious systemic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
At the end of study, stages of Sandhivata (Osteoarthritis) can be diagnosed in a more accurate way with
the help of AI tool which will be further helpful in treatment approach. |
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AT THE END OF THE STUDY STAGES OF OSTEOARTHRITIS(SANDHIVATA) CAN BE DIAGNOSED IN A MORE ACCURATE WAY WITH THE HELP OF AI TOOL WHICH WILL BE FURTHER HELPFUL IN TREATMENT APPROACH |
18 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
23/07/2025 |
| 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
|
1. Imaging is useful in monitoring and predicting the prognosis of Sandhivata (Osteoarthritis).
Human may lack preci in evaluating X-Ray and diagnose the exact stage of Sandhivata
(Osteoarthritis). Accurate Artificial Intelligence based predictive model made with the help of
Imaging technique (X-Ray) can be used for early diagnosis of Sandhivata (Osteoarthritis). 2. Keeping in view of above the present study entitled - UTILIZING ARTIFICIAL
INTELLIGENCE FOR DIAGNOSTICS IN SANDHIVATA (OSTEOARTHRITIS) – AN
OBSERVATIONAL STUDY will be carried out to see the diagnostic performance of AI
algorithms in detection and classification of Sandhivata (Osteoarthritis) using imaging
technique. |