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CTRI Number  CTRI/2025/03/081844 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 26/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating the efficacy of medicated oil bandage and medicated oil gauze application in Knee Osteoarthritis. 
Scientific Title of Study   Efficacy of Janu Patch and Janu Pichu Bandhana in Janu Sandhigata Vata: A Non-Inferiority 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 Somnath Meher 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital 
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  7008089150  
Fax    
Email  somnathsomu3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr B A Lohith 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital 
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9886749168  
Fax    
Email  drlohithpk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr B A Lohith 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital 
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9886749168  
Fax    
Email  drlohithpk@gmail.com  
 
Source of Monetary or Material Support  
SDM College of Ayurveda and Hospital, Thanniruhalla, Hassan 573201 
 
Primary Sponsor  
Name  SDM College of Ayurveda and Hospital 
Address  Thanniruhalla, Hassan 573201 
Type of Sponsor  Private medical college 
 
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 
Dr Somnath Meher  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA & HOSPITAL   OPD and IPD under all the departments of Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital, Thanniruhalla, Hassan 573201
Hassan
KARNATAKA 
7008089150

somnathsomu3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL  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: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Janu Patch (Procedure Reference: -, Procedure details: Janu Patch is prepared with absorbing luke warm Mahanarayana Taila with polyethylene absorbent and applied to affected knee joint for 8hrs per day.)
(1) Medicine Name: Mahanarayana Taila , Reference: Bhaishajya Ratnavali Vatarogadhikara Prakaranam, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-Janu Pichu Bandhana (Procedure Reference: -, Procedure details: Janu Pichu Bandhana is done with absorbing cotton gauze with luke warm Mahanarayana Taila and applied all around the affected knee joint and bandaged for 8hrs per day.)
(1) Medicine Name: Mahanarayana Taila , Reference: Bhaishajya Ratnavali Vatarogadhikara Prakaranam, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects with features of Sandhigata Vata in unilateral or bilateral Janu Sandhi.
2. Subjects willing to sign consent form.
3. Subjects fit to undergo Janu Patch and Janu Pichu Bandhana. 
 
ExclusionCriteria 
Details  1. Subjects with any other systemic disorders like HIV, HBsAg.
2. Traumatic cases like fracture.
3. Diagnosed cases of Vatarakta and Amavata. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Subjective Parameters
1. Sandhi Shotha
2. Sandhi Shoola
3. Sandhi Graha
4. Akunchana Prasaranayoh Vedana
5. Sandhi Sphutana
6. Sparsha Asahyatwa

Objective Parameters
1. Range of movement: measured using goniometer
2. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
 
7days 
 
Secondary Outcome  
Outcome  TimePoints 
To improve lifestyle.  15 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 2 
Date of First Enrollment (India)   18/03/2025 
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="2"
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  

In India, Osteoarthritis affects approximately 15 million adults annually, with a prevalence ranging from 22% to 39%. This degenerative joint condition is the most common form of arthritis which causes pain, swelling, and stiffness, significantly impacting a person’s ability to move freely. It affects the entire joint, including surrounding tissues, and is most prevalent in the knees, hips, spine, and hands. Factors contributing to its development includes a history of joint injury or overuse, older age, and being overweight. Notably, 73% of subjects with osteoarthritis are older than 55 years, and 60% are female. In Ayurveda, the disease Sandhigata Vata resembles with Osteoarthritis, which is described under Vata Vyadhi. The knee is the most frequently affected joint, followed by the hip and the hand. The treatment approach for Sandhigata Vata involves specific therapeutic methods, including Snehana (oleation), Upanaha (local poultice), Agnikarma (thermal cauterization), Bandhana (bandaging), and Mardana (massage).

Janu Pichu Bandhana, an external therapeutic procedure where Snehana and Bandhana is done concurrently. It is derived from Shiro Pichu which falls under the category of Moordhni Taila treatments. Among these Moordhni Taila, Pichu is particularly more effective compared to abhyanga (oil massage) and seka (pouring of medicated liquids). Here an effort has been made to modify the conventional Janu Pichu Bandhana in the form of Janu Patch to make it more convenient for application and also to see the effectiveness of Janu Patch with that of Janu Pichu Bandhana. If this Janu Patch demonstrates positive effect on Sandhigata Vata, then it may potentially replace the conventional Janu Pichu Bandhana.

Mahanarayana Taila is derived from a blend of potent herbs and processed in Tila Taila, this therapeutic oil can be used in various ways and offers multifaceted benefits for Vata Rogas. Mahanarayana Taila exhibits Brimhana properties, pacifies Vata dosha, acts as Balya and provides relief from Amaya. Hence, all these positive outcomes make it the gold standard dravya for managing Janu Sandhigata Vata.

Although Janu Pichu Bandhana is widely practiced, there is no sufficient research has been done on this procedure. Thus, for current study Janu Pichu Bandhana and development of Janu Patch is taken for managing Janu Sandhigata Vata.

 
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