| CTRI Number |
CTRI/2025/05/087460 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare effects of ketakimooladi oil and Til oil local massage in treatment of Knee osteoarthritis |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON THE EFFICACY OF JANUABHYANGA BY KETAKIMOOLADI TAIL AND TILA TAIL IN JANUSANDHIGAT VATA WSR 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 |
DrSupriya Shrikant Tiwari |
| Designation |
Post graduate resident |
| Affiliation |
APMs Ayurveda Mahavidyalay Sion |
| Address |
Department of Panchkarma , Second floor ,APMs Ayurved Mahavidyalay , near Sion railway station , Sion , Mumbai , 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8788440478 |
| Fax |
|
| Email |
stiwarisupriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRajendra Govind More |
| Designation |
Head of Department , Panchkarma department |
| Affiliation |
APMs Ayurveda Mahavidyalay ,Sion, Mumbai |
| Address |
Department of Panchkarma , Second floor ,APMs Ayurved Mahavidyalay , near Sion railway station , Sion , Mumbai , 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9967520554 |
| Fax |
|
| Email |
rushir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRajendra Govind More |
| Designation |
Head of Department , Panchkarma department |
| Affiliation |
APMs Ayurveda Mahavidyalay ,Sion, Mumbai |
| Address |
Department of Panchkarma , Second floor ,APMs Ayurved Mahavidyalay , near Sion railway station , Sion , Mumbai , 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9967520554 |
| Fax |
|
| Email |
rushir@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Seth R V Ayurveda Hospital |
| Address |
Near Sion railway station Sion Mumbai, maharashtra, india - 400022. |
| Type of Sponsor |
Other [Ayurvedic government aided] |
|
|
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 Supriya Tiwari |
Seth R.V. Ayurvedic Hospital |
OPD no 1, Dept. of panchakarma, Near sion railway station, sion, mumbai.
Mumbai
MAHARASHTRA |
8788440478
stiwarisupriya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurveda Mahavidyalay, Sion , IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M15-M19||Osteoarthritis. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tila tail, Reference: Charak Sutrasthan adhyay 27 shlok 285 to 288, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ketakimooladi Taila, Reference: Gadnigraha kaychikitsa bhag adhyay 19 shlok 181, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with the signs and symptoms of Janusandhigata vata supplemented with that
of Osteoarthritis of knee are the main criteria for the diagnosis.
1) Patient of both genders
2) Patient in the age group above 18 years and below 70 years.
3) Radiological evidences of Osteoarthritis of knee joint.
4) Pain and restricted movement of the knee joint.
5) Presence of crepitus, pain and swelling of knee joint.
6) Patients with radiological findings of Osteoarthritis based on grade 0 to 4 on
Kellgren and Lawrence system of classification of Knee OA 2 along with clinical
features. |
|
| ExclusionCriteria |
| Details |
1) Patients suffering from Rheumatoid arthritis, Rheumatic fever, Rheumatic Heart
disease, Gouty arthritis, Psoriatic arthritis, sciatica
2) Patient with congenital or acquired abnormality related to joint.
3) Patients associated with simple or compound fracture, associated with trauma
,ligament tear .
4) K/C/O Immuno compromised patients
5) Patient suffering from Infective conditions like Hepatitis B, HIV, TB, and carcinoma
etc.
6) Patient undergoing steroid therapy.
7) Patient having joint deformity
8)Pregnant women and lactating mother . |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| sandhishoola |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| atop, aakunchan - prasaran vedana, sandhishotha |
7 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/06/2025 |
| 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="2" |
|
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
|
“Sandhigatvaat” is one of the most common vata vyadhi which is a joint disorder common amongst elderly and obese persons.It is firstly described in ayurvedic texts as “sandhigatanila”2
specific symptoms being –
-Prasarana akunchanyoh savedana,Sandhishoola ,Sandhishotha,Vata purna druti sparsh ,Hanti sandhigatah It is a subset of vata vyadhi as vitiated vata gets lodged in janu sandhi and produce symptoms of sandhigat vata such as pain in joints , crepitus in joints ,swelling on palpation, stiffness of joint, restriction of movements of joint Hence, textual line of treatment of vata vyadhi can be followed in janu sandhigat vata as it is localised form of vata vyadhi . “Snehana” is the main line of treatment for vatavyadhi as it is almost pollary opposite of vata Sneha diminishes anila that is vata ,softens body and breaks any dosha sanga if present as in jaanusandhigat vata dosha sanga resides in jaanu sandhi ,it has the capability of going into minute channels of the body where doshas resides in leena form . |