| CTRI Number |
CTRI/2025/04/084976 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
tool development and validation |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Diagnostic Tool for Janu Sandhigatavata |
|
Scientific Title of Study
|
Development and Validation of Diagnostic Tool for Janu Sandhigatavata with Special Reference to Knee Osteoarthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemlata Shete |
| Designation |
PhD scholar |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya |
| Address |
Roganidana Department
Ground floor
Roganidana department
KAHER Shri BMK Ayurveda Mahavidyalaya, Shahpur, Belagavi
Roganidana Department
Ground floor
Roganidana department
KAHER Shri BMK Ayurveda Mahavidyalaya, Shahpur, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8217623771 |
| Fax |
|
| Email |
hemalata.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Suhas Kumar Shetty |
| Designation |
PhD Guide |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya |
| Address |
Kayachikitsa Department
second floor
Kayachikitsa department
KAHER Shri BMK Ayurveda Mahavidyalaya, Shahpur, Belagavi
Kayachikitsa Department
second floor
kayachikitsa department
KAHER Shri BMK Ayurveda Mahavidyalaya, Shahpur, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9449603234 |
| Fax |
|
| Email |
drsuhasshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hemlata Shete |
| Designation |
PhD scholar |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya |
| Address |
Roganidana Department
Ground floor
Roganidana department
KAHER Shri BMK Ayurveda Mahavidyalaya, Shahpur, Belagavi
Roganidana Department
Ground floor
Roganidana department
KAHER Shri BMK Ayurveda Mahavidyalaya, Shahpur, Belagavi
KARNATAKA
590010
India |
| Phone |
8217623771 |
| Fax |
|
| Email |
hemalata.kaher@kleayurworld.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr Hemlata Shete
Associate professor
Department of Roganidana
KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Self] |
|
|
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 Gajendra |
KLE Ayurveda Hospital |
OPD no 7, Diagnostic wing, KLE ayurveda Hospital , Shahpur, Belagavi
Belgaum
KARNATAKA |
99648 33033
kleayurvedahospital@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Ethical Committee (Human) for PhD Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting with the classical symptoms of sandhivata |
|
| ExclusionCriteria |
| Details |
Developed as a complication of systemic disease like Thyroid Asthma Malignancies Liver disorders Uncontrolled hypertension uncontrolled diabetes mellitus & Chronic renal failure.
No Trauma infections and tumours
Patients with classical symptoms of Amavata and vatarakta
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Developing Ayurveda standardized diagnostic methods and tools, particularly for disease diagnosis and clinical practice and ensure the reliability and validity of Ayurvedic clinical practices.
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Understand determinants(nidana) of Janu sandhi gata vata |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
10/05/2025 |
| 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="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
Modification(s)
|
•The majority of ayurvedic clinical studies conducted today use generic instruments that are based on references from traditional texts, even if they haven’t been properly validated. Additionally, given that the pathological concepts of Ayurveda are based on the functional derangements of dosha, there are also no established goldstandards like histopathology, for validating these tools. Hence,there is a need for developing and validating diagnostic tools for diseases enumerated in Ayurveda, to standardise the clinical approach, even when attempting for a patient-centric, individualised diagnosisCurrently, no diagnostic tools are available for an ayurvedist to identify this clinical entity and many a time, the situation is overlooked. Hence, developing a comprehensive clinical profile and a diagnostic tool is the need of the hour for offering precise clinical solutions. the study aims To develop and validate diagnostic tool for Janu sandhigatavata as per principles and practice of Ayurveda and the objectives are 1.To Diagnose sandhigata vata using ayurvedic and modern diagnostic tool. 2.To develop and validate diagnostic tool/process for Janu sandhigatavata (Knee Osteoarthritis).The study employs a mixed-methods approach to develop and validate a diagnostic tool for Janu Sandhigatavata. Conducted in four phases, it begins with defining diagnostic criteria and formulating questionnaire items through literature reviews, expert surveys, and focus group discussions. Phase II involves pre-testing the tool for respondent friendliness, face/content validity, and translation equivalence. Phase III focuses on refining the tool through expert input and domain reduction. Phase IV assesses the tool’s reliability (inter-rater and internal consistency) and clinical validity against expert panel diagnoses using statistical methods like Kappa statistics and Cronbach’s alpha. Additionally, an analytical study of Janu Sandhigatavata determinants will be conducted on 140 participants, adhering to strict inclusion and exclusion criteria. Ethical approval, informed consent, and Good Clinical Practice guidelines will ensure compliance with ethical standards. Statistical analyses include chi-square tests, regression, and descriptive statistics, with significance set at 5%. The study will be completed within 3–4 years at KAHER’s Ayurveda Mahavidyalaya, Belagavi. Version II : Protocol/Synopsis version II was submitted to the university Dept of Academic affairs on January 2026, |