| CTRI Number |
CTRI/2025/07/090701 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Jivha Pareeksha Toungue Examination in Amvata Rheumatoid Arthiritis and its comparision with healthy individual through artificial intelligence |
|
Scientific Title of Study
|
Standardisation of Jivha Pareeksha Toungue Examination in Amvata Rheumatoid Athiritis with the help of Machine Learning A Cross Sectional Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 00 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshita Saxena |
| Designation |
Md Scholar |
| Affiliation |
Pandit Khushilal Sharma goverment Ayurveda Colllege and Inastitute Bhopal |
| Address |
Pg Deaprtment of Rog Nidan Evam vikruti vigyan Pandit Khushilal Sharma goverment Ayurveda Colllege and Inastitute Behind Manit Nehru Nagar Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
08982256432 |
| Fax |
|
| Email |
saxenaharshita51297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Jain |
| Designation |
Associate professor of roga nidana evum vikruti vigyan department |
| Affiliation |
Pandit Khushilal Sharma goverment Ayurveda Colllege and Inastitute Bhopal |
| Address |
Deaprtment of Rog Nidan Evam vikruti vigyan Room no.6 Pandit Khushilal Sharma goverment Ayurveda Colllege and Inastitute Behind Manit Nehru Nagar Bhopal India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9827730455 |
| Fax |
|
| Email |
Rajeshjain1075@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshita Saxena |
| Designation |
Md Scholar |
| Affiliation |
Pandit Khushilal Sharma goverment Ayurveda Colllege and Inastitute Bhopal |
| Address |
Pg Deaprtment of Rog Nidan Evam vikruti vigyan Pandit Khushilal Sharma goverment Ayurveda Colllege and Inastitute Behind Manit Nehru Nagar Bhopal
MADHYA PRADESH
462003
India |
| Phone |
08982256432 |
| Fax |
|
| Email |
saxenaharshita51297@gmail.com |
|
|
Source of Monetary or Material Support
|
| No Sponsor |
| PT khushilal sharma GOVT. AUTO AYURVEDA COLLEGE AND INTSTITUTE BHOPAL |
|
|
Primary Sponsor
|
| Name |
Pandit khushilal Sharma Govt Autonmous Ayurveda Institute Bhopal MP |
| Address |
Science hills behind MANIT .KOLAR Nehru Nagar Bypas 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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Harshita Saxena |
Dr harshita Saxena |
Pg Departement of Roga nidana evum vikruti vigyan Goverment Ayurveda College and Institute bScience Hills Behind Manit Nehru Nagar Bhopal
Bhopal
MADHYA PRADESH |
08982256432
saxenaharshita51297@gmail.com |
| Dr Harshita Saxena |
PT KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE & INSTITUTE BHOPAL |
DEPARTMENT OF ROGA NIDANA ROOM NO 6 SCIENCE HILLS BEHIND MANIT .KOLAR NEHRU NAGAR BYPASS ROAD , BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH |
08982256432
saxenaharshita51297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Pandit Khushilal Sharma goverment Ayurveda College Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M259||Joint disorder, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cases of Amavata Rheumatoid Arthritis as described in Modern Medicine as
well Ayurveda lectures
Clinically Healthy individual of either sex having age between twenty one to sixty years
Patients and Healthy volunteers willing to give written informed consent for the
participation in the proposed Research work |
|
| ExclusionCriteria |
| Details |
Patients and Clinically Healthy Individuals not fulfilling inclusion criteria
Pregnant woman and lactating mother
Patients suffering any other chronic diseases
Patient with oral infection eg candida etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that at the end of the study we would be able to explore that Tongue examination is useful in diagnosing Rheumatoid arthritis.
|
It is expected that at the end of the study we would be able to explore that Tongue examination is useful in diagnosing Rheumatoid arthritis.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| |
|
It is expected that at the end of the study we would be able to explore that Tongue examination is useful in diagnosing Rheumatoid arthritis.
|
It is expected that at the end of the study we would be able to explore that Tongue examination is useful in diagnosing Rheumatoid arthritis.
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
25/07/2025 |
| 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="18"
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
|
The patient examination is the preliminary step for initiating diagnosis and management For clinical examination various methods like Ashtasthan Pariksha Shadvidh Pariksha and Dashvidh Pariksha etc has been explained one Among these methods of examination Ashtasthan Pariksha Eightfold examination is very popular and scientific method of clinical assessment of patient and their prognosis two Jivha Pariksha Tongue examination stands on fourth place in Ashtasthan Pariksha Eightfold examination The examination of Tongue examination includes shape size colour moisture and coating of tongue The pathological investigations at regular interval are very expensive and is out of reach from common man Jivha Pariksha Tongue examination is very cheap method of clinical examination which can helps diagnosis as well as prognosis of disease The rapid development of machine learning technologies has gradually extended from the general field to all walks of life and intelligent tongue diagnosis is the product of miraculous connection between his new discipline and traditional disciplines With the rapid development of society and the continuous collision between traditional and modern sciences more and more tongue diagnostic researchers full of curiosity have carried out active exploration Tongue diagnosis is an important means to obtain disease information because of the abundant superficial vascular tissue the tongue can transmit many useful signals in real time which may indicate important medical information In this point as the only noninvasive method to explore organs in vivo |