| CTRI Number |
CTRI/2026/02/104939 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Ayurvedic Oil Therapy and Traction in Knee Osteoarthritis |
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate the efficacy Janu Dhara and Janu Basti with Parijaat Nirgundi Taila followed by traction in the Management of Janu Sandhigata Vata (Osteoarthritis of Knee) |
| 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 Bhavesh Dendor |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute of Ayurved, Jodhpur |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurved, Jodhpur, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Campus Karwar Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
07023896548 |
| Fax |
|
| Email |
bhaveshdendor98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Professor, Head Of Panchakarma Department |
| Affiliation |
Post Graduate Institute of Ayurved, Jodhpur |
| Address |
Post Graduate Institute of Ayurved, Jodhpur
PG Department of Panchakarma Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Karwar Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Professor, Head Of Panchakarma Department |
| Affiliation |
Post Graduate Institute of Ayurved, Jodhpur |
| Address |
Post Graduate Institute of Ayurved, Jodhpur
PG Department of Panchakarma Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Karwar Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur 342037 Rajasthan INDIA |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved, Jodhpur |
| Address |
PG Department of Panchakarma Post Graduate Institute of Ayurved DSRRAU Jodhpur 342037 Jodhpur RAJASTHAN India |
| Type of Sponsor |
Government medical college |
|
|
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 Bhavesh Dendor |
Post Graduate Institute of Ayurved DSRRAU, Jodhpur |
PG Department of Panchakarma Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Karwar Jodhpur
Jodhpur
RAJASTHAN |
07023896548
bhaveshdendor98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Post Graduate Institute of Ayurved |
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 | | 1 | Intervention Arm | Procedure | - | jAnu-bastiH, जानु-बस्तिः | (Procedure Reference: Charak chikitsa 28/78, Procedure details: 20 patients will be treated with janubasti with Parijaat Nirgundi Taila in which Masha Pishti is prepared by mixing Masha powder with sufficient water to form a thick paste. The patient lies supine with the knee fully extended, & a circular wall of about 4 angula height is made around the knee using the paste. Warm Parijaat Nirgundi Taila is poured into the enclosure up to 2 angula and maintained at a tolerable temperature for 45 minutes, with periodic recycling of the oil.)
(1) Medicine Name: Parijaat Nirgundi Taila, Reference: Raj nighntu 4/156, Route: Topical, Dosage Form: Taila, Dose: 400(ml), Frequency: od, Duration: 15 Days | | 2 | Intervention Arm | Procedure | - | pariSheka, परिषेक | (Procedure Reference: Charak chikitsa 28/78, Procedure details: 20 patients will be treated with janudhara in which Patient is advised to lie down in supine position & to sit comfortably with affected knee joint exposed than Mridu Abhyanga will be done for 5 minutes over affected area, Parijaat Nirgundi Taila Dhara is continuously dropped over with 12 Angula height on the affected joint. Dhara is dropped over both anterior & posterior part of Knee joint.The temperature of oil will be maintained according to patient tolerance power. This procedure will be carried out for 45 minutes with recycle,followed by traction procedure in which a gentle pulling force is applied to the leg to slightly separate the knee joint surfaces, helping to reduce pressure within the joint.)
(1) Medicine Name: Parijaat Nirgundi, Reference: Raj nighntu 4/156, Route: Topical, Dosage Form: Taila, Dose: 1000(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed and confirmed cases of janusandhigata vata (osteoarthritis of knee) as per CRF & on the basis of the sign & symptoms.
Patient between the age group of 20-70 years of either sex.
Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent proforma. |
|
| ExclusionCriteria |
| Details |
Patients suffering from disease like Rheumatoid arthritis, gout.
Patients suffering with other systemic chronic disorders like Malignancy, Cardiac and Renal disease.
Traumatic cases like fracture. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the effect on Assessment of Clinical Photographic changes in x-ray B/L knee joint AP &Lat view. |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see any other effects in Subjective parameters ,drug and procedure. |
45 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="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
|
Study Type - InterventionalNumber Of Patients- 40(20 Patients in each group)Type of study- Open LabelledDuration of study-Group A (JANUDHARA with traction) Total duration of treatment 15days Group B (JANUBASTI with traction) Total duration of treatment 15 days Follow up next 15th 30th days
|