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CTRI Number  CTRI/2026/01/102499 [Registered on: 30/01/2026] Trial Registered Prospectively
Last Modified On: 30/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical Study to Validate Proper Signs of Steam Therapy in Knee Osteoarthritis Patients. 
Scientific Title of Study   Clinical validation of Samyak Swedana Lakshana in Patients with Janu Sandhigata Vata (Knee Osteoarthritis): A single arm clinical study 
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 Manisha Sunil Ghuge 
Designation  PG Scholar MD Panchakarma 
Affiliation  MES Ayurved Mahavidyalaya 
Address  Second Floor, Panchakarma Department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt-Lote, Taluka Khed, District Ratnagiri, Maharashtra 415722, India.

Ratnagiri
MAHARASHTRA
415722
India 
Phone  9322928059  
Fax    
Email  manishaghuge07061999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sachin Vasant Utpat 
Designation  Professor and Department of Panchakarma 
Affiliation  MES Ayurved Mahavidyalaya 
Address  Second Floor, Panchakarma Department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt-Lote, Taluka Khed, District Ratnagiri, Maharashtra 415722, India.

Ratnagiri
MAHARASHTRA
415722
India 
Phone  8411972626  
Fax    
Email  svu.phl@mespune.in  
 
Details of Contact Person
Public Query  
Name  Dr Manisha Sunil Ghuge 
Designation  PG Scholar MD Panchakarma 
Affiliation  MES Ayurved Mahavidyalaya 
Address  Second Floor, Panchakarma Department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt-Lote, Taluka Khed, District Ratnagiri, Maharashtra 415722, India.

Ratnagiri
MAHARASHTRA
415722
India 
Phone  9322928059  
Fax    
Email  manishaghuge07061999@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Manisha Sunil Ghuge 
Address  MES Ayurved Mahavidyalaya,Ghanekhut Lote,Khed,Rantagiri 415722 India 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Drmanisha sunil ghuge   Dr.manisha sunil ghuge   Second Floor, Panchakarma Department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt-Lote, Taluka Khed, District Ratnagiri, Maharashtra 415722, India.
Ratnagiri
MAHARASHTRA 		 9322928059

manishaghuge07061999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MES Ayurved Mahavidyalaya  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: JANUBEDAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nADIsvedaH, नाडीस्वेदः (Procedure Reference: ch.su.14, Procedure details: Purvakarama- 1.Apply local Abhyanga (e.g.Til Taila) for 5–7 minutes 2.Prepare Dashamoola Kwatha or prescribed decoction in Swedana Yantra. 3.Check steam flow & maintain a tolerable temperature (40–45°C). 4.Ensure therapy room is warm, free from draught, & all materials (towel, cotton pads, protective sheets) are ready. Pradhan Karam- 1.Position patient with knee exposed & relaxed. 2.Direct the Nadi (tube) towards the knee joint, keeping ~10–12 inches distance. 3.Release steam gradually and move nozzle in a circular/sweeping motion around the knee, avoiding prolonged focus on one spot. 4.Continue for 5-7 minutes or until Samyak Swedana Lakshana appear:- Relief in stiffness (Stambha) Relief in pain (Shula) Feeling of lightness (Laghuta) Mild perspiration at the site 5.Monitor patient’s comfort throughout the session. Stop if burning, dizziness, or intolerance occurs. Paschan Karma- 1.Wipe knee gently with a dry towel. 2.Allow patient to rest in a warm environment for 15–20 minutes. 3.Provide lukewarm water to drink. )
(1) Medicine Name: 1.Tila Taila 2.Dashmul bharad, Reference: su.su.38/66, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 5(g), Frequency: od, Duration: 7 Days
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age group 40 to 70 years.
2.Patient having sign and symptoms of janusandhigata vata according to classics
a)Sandh shoola
b)Sandhi shoth
c)Vatapurnadruti sparsh
d)Prasarana Aakunchana vedana

3.Patient willing and able to participate in study, irrespective of any gender,occupation,religion,economic status.

4.Radiological degenrative changes in knee joints
5.Patients who are ready to switch over to ayurved medicine
6.Patients who will fulfill the criteria and take regular medicines with regular medicines with regular follow up 
 
ExclusionCriteria 
Details  1.Patient who can’t answer the questionaries.
2.Patient who are not fit for swedana.
3.Diagnosed patient and cancer, neurological disorder,cardiovascular disease, Paralysis etc.
4.Patient with Rheumatoid Arthritis,Rheumatic fever,Rheumatic Heart disease, Arthritis and Infective Arthritis,Koch’s disease.
5.Patient who will not issue written consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To validate classical signs of samyak swedana in patient with Janusandhigatavata through a structured Ayurvedic assessment and correlate them with clinical improvements in pain,stiffness and joint function  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess therapeutic efficacy of swedana in term of shoola prashmana(pain relief),stambhaghnata(reduction in stiffness),mardavajanana(improvement in softness).
2.To correlate subjective improvement with objective assessment like VAS,ROM,WOMAC,TUG and Digital skin Analyzer.
3.To study swedana procedure in detail.
 		 7 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   16/02/2026 
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  
This study aims to evaluate the effectiveness of Nadi Swedana (steam therapy) in patients suffering from knee osteoarthritis, which is described in Ayurveda as Janu Sandhigata Vata. Modern lifestyle factors often increase Vata dosha, leading to knee pain, stiffness, swelling, and difficulty in movement. Swedana is an important Ayurvedic therapy used to relieve these symptoms, but its proper effect is confirmed only when specific signs called Samyak Swedana Lakshanas appear, such as relief from pain and stiffness, lightness, and softness in the joint.
In this single-arm clinical study, 60 patients aged 40–70 years with knee osteoarthritis will receive Nadi Swedana using herbal steam. The study will observe classical Ayurvedic signs of proper swedana and correlate them with modern assessment tools like pain scales, joint movement, walking tests, and questionnaires. The purpose is to scientifically validate traditional Ayurvedic concepts and assess the safety and effectiveness of Swedana therapy in knee.
 
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