| CTRI Number |
CTRI/2025/03/082762 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
AN OBSERVATIONAL STUDY TO ANALYSE KEVALAVATA AND SAMSRSHTA/AVRUTA VATA LAKSHANA IN KNEE JOINT DISORDERS |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY TO ANALYSE KEVALAVATA AND SAMSRSHTA/AVRUTA VATA LAKSHANA IN JANUSANDHIGATA VATA |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anushree S Rao |
| Designation |
2 nd Year PG Scholar samhita siddhanta |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan |
| Address |
Depth of Samhita Siddhanta 3rd floor
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
8762129113 |
| Fax |
|
| Email |
anualankar99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrinath M Vaidya |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan |
| Address |
Dept of Samhita Siddhanta
3rd floor
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
8762129113 |
| Fax |
|
| Email |
dr.shrinathvaidya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anushree S Rao |
| Designation |
2 nd Year PG Scholar samhita siddhanta |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan |
| Address |
Depth of Samhita Siddhanta 3rd floor
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
8762129113 |
| Fax |
|
| Email |
anualankar99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College and hospital Hassan 573201 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan |
Sri Dharmasthala Manjunatheshwara College and hospital Hassan 573201 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anushree S Rao |
Sri Dharmasthala Manjunatheshwara Ayurveda hospital hassan |
3rd floor
Dept of ayurveda Samhitha and Siddhanta
Hassan
KARNATAKA |
8762129113
anualankar99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College Of Ayurveda hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient of either gender with janusandhigata vata lakshana within 5 years of its manifestation
2.subjects of janusandhigata vata ages 40-70 |
|
| ExclusionCriteria |
| Details |
1. Subject suffering from Janusandhigata Vata with bony deformity fracture and external injuries
are excluded
2. Subject suffering from diseases like Amavata, Vatarakta are excluded.
3. Subjects who are undergoing steroids or hormonal treatment or who have previously undergone
such treatments.
4. Subjects with Juvenile musculoskeletal diseases.
5. Subjects suffering from uncontrolled type2 DM and other endocrine diseases and on its
treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The findings are expected to enhance diagnostic precision and support personalized treatment planning for Janusandhigata Vata. |
8months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study’s secondary outcome is to analyze & categorize the clinical features of Janusandhigata Vata into two subtypes—Kevala Vata (where Vata is predominantly involved) & Samsrshta/Avruta Vata (where Vata is compounded by other doshas). |
1 week |
|
|
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)
|
28/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/03/2025 |
| 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 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 observational study investigates Janusandhigata Vata by differentiating between its two clinical manifestations—Kevala Vata (pure Vata involvement) and Samsrshta/Avruta Vata (Vata complicated by other doshas). It aims to deepen the understanding of the underlying pathogenesis of Vata disorders affecting the joints, as described in classical Ayurvedic texts. A specially designed proforma, based on extensive literature review, is used to document clinical signs and symptoms. Data will be collected from 100 subjects (aged 40–70) selected from both OPD and IPD settings at SDM hospital and analyzed using appropriate statistical tools |