| CTRI Number |
CTRI/2026/01/101610 [Registered on: 20/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to Assess the Relationship Between Prakriti and Severity of Knee Osteoarthritis |
|
Scientific Title of Study
|
A Clinical Correlation Study Between Prakriti And Functional Severity In Patients Of Sandhigata Vata (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 |
DR PIYUSH SHARMA |
| Designation |
2nd Year PhD Scholar |
| Affiliation |
Shree Swaminarayan Ayurvedic College |
| Address |
Post Graduate Department Of Roga Nidan Evam Vikriti Vigyan
Shree Swaminaraan Ayurvedic College
Gandhinagar
GUJARAT
382725
India |
| Phone |
7018908821 |
| Fax |
|
| Email |
sharmapiyush185@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ROHIT GOKARN |
| Designation |
Principal |
| Affiliation |
Shree Swaminarayan Ayurvedic College |
| Address |
Post Graduate Department Of Rasashastra and Bhaishajya Kalpana Shree Swaminarayan Ayurvedic College
Opp Kalol GIDC Saij Ahmedabad Mehsana Highway AT and PO Ta Saij Kalol
Gandhinagar
GUJARAT
382725
India |
| Phone |
9449231730 |
| Fax |
|
| Email |
rohitgokarn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PIYUSH SHARMA |
| Designation |
2nd Year PhD Scholar |
| Affiliation |
Shree Swaminarayan Ayurvedic College |
| Address |
Post Graduate Department Of Roga Nidan Evam Vikriti Vigyan
Shree Swaminaraan Ayurvedic College
Gandhinagar
GUJARAT
382725
India |
| Phone |
7018908821 |
| Fax |
|
| Email |
sharmapiyush185@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Premswarup Swami Ayurvedic Multi Speciality Hospital Kalol |
| Address |
Shree Swaminarayan Ayurvedic College And Hospital Ahemdabad Mahesana Highway AT and PO Saij Ta Kalol District Gandhinagar Gujrat 382725 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 |
| Prof Rajesh Kumar |
Shiva Ayurvedic Medical College And Hospital |
Department of Roga Nidan Evam Vikriti Vigyan Room No 6 Luhanoo Kanetain Chandpur PO Tehsil Sadar 174004
Bilaspur
HIMACHAL PRADESH |
9805092581
shivabams@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Swaminarayan University Kalol |
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 |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 40–80 years.
Clinically diagnosed cases of Sandhigata Vata as per Ayurvedic and modern diagnostic criteria.
Participants willing to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Patients suffering from Rheumatoid Arthritis & Gout.
Patients with severe comorbidities that may affect the study outcomes.
Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association (correlation) between Prakriti type and functional severity in Sandhigata Vata (Osteoarthritis), measured using WOMAC total score and VAS pain score. |
Baseline / Single assessment at enrollment (Day 0). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between Prakriti type and WOMAC subscales (Pain, Stiffness, Physical Function). |
Baseline / Day 0 |
| Comparison of mean WOMAC and VAS scores among Vata, Pitta and Kapha dominant Prakriti groups. |
Baseline / Day 0 |
| Correlation between Prakriti type and clinical severity indicators (walking difficulty / gait impairment as per assessment tool used in protocol). |
Baseline / Day 0 |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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 is an observational cross sectional analytical study to assess the association between Prakriti type and functional severity in patients of Sandhigata Vata Osteoarthritis A total of 300 patients diagnosed with Sandhigata Vata Osteoarthritis will be enrolled from the OPD and IPD. Prakriti assessment will be done using a validated Prakriti assessment questionnaire Functional severity will be assessed using WOMAC score and pain intensity will be assessed using Visual Analogue Scale The study hypothesis is that functional severity and pain in Sandhigata Vata Osteoarthritis vary significantly among different Prakriti types The findings of this study may help in identifying Prakriti based risk patterns and developing preventive and personalized management strategies in Ayurveda |