| CTRI Number |
CTRI/2026/03/105513 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to evaluate the effect of varunadi kwath decoction Janu Dhara therapy in reducing pain and improving knee function in patients with knee osteoarthritis |
|
Scientific Title of Study
|
Clinical Study on the Effect of Varunadi Kwath Janu Dhara in the Management of
Janu Sandhigat Vata 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 |
Dr Dhanshree keshaorao Sukhsohale |
| Designation |
PG Scholar |
| Affiliation |
Hon shri annasaheb dange ayurved medical college postgraduate and research center ashta |
| Address |
department of panchakarama dhanvantari hospital Hon shri annasaheb dange ayurved medical college postgraduate and research center ashta tal walwa dist sangli 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
7499421079 |
| Fax |
|
| Email |
doctorvaibhaveesukhsohale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shankar Lahuraj Mane |
| Designation |
Professor Department of panchakarma |
| Affiliation |
Hon shri annasaheb dange ayurved medical college postgraduate and research center ashta |
| Address |
4th floor department of panchakarama Hon shri annasaheb dange ayurved medical college postgraduate and research center ashta tal walwa dist sangli 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9922454406 |
| Fax |
|
| Email |
shnkrmane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shankar Lahuraj Mane |
| Designation |
Professor Department of panchakarma |
| Affiliation |
Hon shri annasaheb dange ayurved medical college postgraduate and research center ashta |
| Address |
4th floor department of panchakarama Hon shri annasaheb dange ayurved medical college postgraduate and research center ashta tal walwa dist sangli 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9922454406 |
| Fax |
|
| Email |
shnkrmane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon shri Annasaheb Dange ayurved medical college and research center ashta 416301 Tal walwa Dist Sangli Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Dhanshree Keshaorao Sukhsohale |
| Address |
Department of Panchakarma Hon shri annasaheb dange ayurved medical college and research center ashta 416301 Tal Walwa Dist Sangli Maharashtra India |
| 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 Dhanshree Sukhsohale |
Hon shri annasaheb dange ayurved medical college and research center ashta |
OPD no.9 Panchakarma department Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Center Ashta Sangli
Sangli
MAHARASHTRA |
7499421079
doctorvaibhaveesukhsohale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Center Ashta Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M17||Osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Janu dhara जानू धारा | (Procedure Reference: Charak Sutrasthana 14/39-40, Procedure details: KWATH IS HEATED One liter of the Varunadi kwath is heated approximately up to 45 degree centigrade
KWATH IS POURED
Dhara will be poured at medium speed with the help of varshulika from a height of 9 inch 12 anguli
GENTLE MASSAGE
As the kwath is poured with varshulika on to the patients body therapist gently moves his other palm over the skin following the path of kwath poured This maneuver has the effect of abhyanga
REUSING THE KWATH As the pouring of the kwath is continued the kwath starts
collecting in the vessel kept below the knee joint & the kwath collected that has lost its heat during the procedure before reusing for Janu Dara it should be once again heated This procedure is continued for about 30 minutes)
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1Patient having the signs and symptoms of Janusandhigat vata Sandhishool Sandhishoth Sparshasahtva Akunchanjanyashool Prasaranjanyashool 2Age of patient from 40 to 70 years 3patient will be selected irrespective of gender occupation and habitat 4 patient fit for Janu Dhara |
|
| ExclusionCriteria |
| Details |
Those who do not fit for Janu Dhara
2 Patients below 40 years and above 70 years
3 Any congenital deformity
4 Rheumatoid arthritis
5 Chronic skin disease
6 Gout diabetes mellitus
7 Infectious diseases like osteomyelitis tuberculosis
8 Malignancy primary tumors secondary deposits
9 Pregnant women lactating mothers
10 Patients on NSAIDs regularly and steroid dependent
11 Patients with trauma accident fracture |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 To determine efficacy of Varunadi Kwath Janu Dhara in Janu Sandhigat Vata with special reference to Knee Osteoarthritis |
7 day 14 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2026 |
| 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="6"
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
|
Knee Osteoarthritis is a chronic degenerative disorder characterized by pain stiffness swelling and restricted movement leading to functional impairment In Ayurveda it correlates with Janu Sandhigata Vata presenting with Vatapurna Druti Sparsha Shotha Sparsha Asahatva and Prasarana Akunchana Vedana Swedana is a principal management in Sandhigata Vata described in Charaka Samhita and Yogratnakara as it relieves Stambha Gaurava and Sheeta Parisheka Sweda or Janu Dhara is a localized sudation therapy using warm medicated liquid over the affected joint Varunadi Kwatha having Vata Kapha hara Shothahara and Shoolahara The study aims to evaluate the clinical efficacy of Varunadi Kwatha based Janu Dhara in Janu Sandhigata Vata |