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CTRI Number  CTRI/2025/02/080779 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 17/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Effect of Brihatyadi Upanaha Sweda in the Management of Janu Sandhigatavata 
Scientific Title of Study   Single Arm Clinical study to access the Efficacy of Brihatyadi Upanaha Sweda in the Management of Janu Sandhigatavata 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tejaswini Suresh Taksande 
Designation  PG Scholar 
Affiliation  LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur, Sangli  
Address  OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur, Sangli, Maharashtra 415409 India

Sangli
MAHARASHTRA
415409
India 
Phone  7350405455  
Fax    
Email  dr.tejaswini4@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonal Shah 
Designation  HOD and Professor 
Affiliation  LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur, Sangli  
Address  OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur, Sangli, Maharashtra 415409 India

Sangli
MAHARASHTRA
415409
India 
Phone  7972759476  
Fax    
Email  drsonalshah2014@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sonal Shah 
Designation  HOD and Professor 
Affiliation  LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur, Sangli  
Address  OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur, Sangli, Maharashtra 415409 India

Sangli
MAHARASHTRA
415409
India 
Phone  7972759476  
Fax    
Email  drsonalshah2014@gmail.com  
 
Source of Monetary or Material Support  
LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur Sangli 415409  
 
Primary Sponsor  
Name  Tejaswini Suresh Taksande 
Address  OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center, Urun Islampur, Sangli 415409  
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 
Dr Tejaswini Suresh Taksande  LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur, Sangli  OPD No 1 Kayachikitsa Department Sangli Maharashtra
Sangli
MAHARASHTRA 
7350405455

dr.tejaswini4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical commitee LRP Ayurvedic medical college and hospital and PCT and RC Approved  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-upanAhaH (niragniH), उपनाहः (निरग्निः) (Procedure Reference: Su.Chikitsasthana.4/16, Procedure details: 1. Poorva Karma 2. Pradhana Karma 3. Paschat Karma Upanaha will be advised to remove after 4 hours of duration. )
(1) Medicine Name: Bhrihatyadi Upanaha Sweda, Reference: Su.Sutrasthana.38/31-32, Route: Topical, Dosage Form: Churna/ Powder, Dose: 1(NA), Frequency: od, Duration: 1 Weeks
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients in age group of 50 to 70 years.
2. Patients satisfying the diagnostic criteria. needed for diagnosis of Janu Sandhigatavata.
3. Suitable patients for Swedana theraphy. 
 
ExclusionCriteria 
Details  1. Patient with k/c/o Amavata, Vatarakta.
2. Patient with k/c/o Auto immune disease i.e., Ankylosing Spondylitis.
3. Patient with total knee joint replacement.
4. Patient having skin allergies/disease. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of Brihatyadi Upanaha Sweda in the management of Janu Sandhigatavata.  21 Days
 
 
Secondary Outcome  
Outcome  TimePoints 
1) To study Sandhigatavata in detail as per Ayurvedic aspect.
2) To study the role of Upanaha Sweda in Janu Sandhigatavata in detail.
3) To study probable mode of action of Upanaha Sweda, its effect & adverse effect if any. 
12 Months 
 
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/ Phase 3 
Date of First Enrollment (India)   03/03/2025 
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="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  
Sandhigatavata is one of the non-threatening diseases affecting the mobility of multiple joints. Even though multiple joints are affected, knee joints are more prone for damage, since they are weight bearing joints. Mobility is the important feature of life, which is dependent on the structural as well as functional character of the body. As the age advances, though the proper nourishment is available, the body loses its qualitative capacity of the structure and functions. 
In Ayurveda, Sandhigatavata is not described as a separate disease. It is mentioned by the Acharyas as one of the Vatavyadhi. When age gets older & older undergoes kshaya, which results in Vataprakopa & makes people more prone to a wide range of disease.
Sandhigatavata is characterized by symptoms like Sandhishotha (Joint swelling), Vatapurna Druti Sparshah (which is palpable as an air-filled bag) and Prasaaran-Aakunchanayo Pravruttischa Vedana (painful joint movement).
Aggravation of Vayu in the joint gives rise to oedema, which on palpation appears as an air-filled bag and pain while making efforts for flexion & extension of the joint.
Sandhigatavata is one of the most common Vatavyadhi, which can be correlated with Osteoarthritis, the Prevalence Rate of Osteoarthritis is total 14.8% in which Knee Osteoarthritis Prevalence Rate is 10.8%.
Sandhigatavata is the most prevalent type of articular disorder, which restricts daily activities, due to painful joint movements that make the patient disabled. Specially Janu Sandhigatavata is one among the few encounted disease in the hospitals with higher prevalence in India.
Sushruta has mentioned Upanaha Sweda in Vataroga. In case of Sankuchita (Contracture), Rujartha (Acute Pain), & Stabdhagatra (Stiffness) Upanaha Sweda is indicated.
Upanaha Sweda is one of the types of Swedana which is safe procedure and it can gives good result in Janu Sandhigatavata, due to its Vataghna properties and also due to its Ushna and Snigdha guna it acts against Vata guna like Ruksha, Khara, and Laghu.
The toxic metabolic products are eliminated, as a result of the elevated temperature through increased blood flow & perspiration.
Upanaha Sweda has been used as the therapy modality. Because of its composition with several drugs that have different properties; it quickly relieves pain and stiffness. Therefore, Upanaha Sweda plays a specific role in the management of Janu Sandhigatavata without affecting the body’s systemic health.
 
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