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CTRI Number  CTRI/2020/03/024358 [Registered on: 30/03/2020] Trial Registered Prospectively
Last Modified On: 26/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of symptoms of knee joint pain with its structural and functional changes 
Scientific Title of Study   A cross sectional study to evaluate the structural and functional changes in janu sandhi (knee joint) with special reference to symptoms of –sandhigata vata i.e. osteoarthritis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Varsha Sadhale 
Designation  Assistant Professor and PhD scholor 
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik 
Address  Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik Ganeshwadi Panchavati Nashik

Nashik
MAHARASHTRA
422003
India 
Phone  02532513112  
Fax    
Email  shravanigirishkulkarni@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pramod Budruk 
Designation  Professor  
Affiliation  JJ Magdum Ayurved Medical College Jaisingpur 
Address  JJ Magdum Ayurved Medical College Jaisingpur Dist Sangali

Sangli
MAHARASHTRA
416101
India 
Phone    
Fax    
Email  pramodbudruk@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pramod Budruk 
Designation  Professor  
Affiliation  JJ Magdum Ayurved Medical College Jaisingpur 
Address  JJ Magdum Ayurved Medical College Jaisingpur Dist Sangali

Sangli
MAHARASHTRA
416101
India 
Phone    
Fax    
Email  pramodbudruk@rediffmail.com  
 
Source of Monetary or Material Support  
self 
 
Primary Sponsor  
Name  Dr Varsha Sadhale 
Address  Ayurved seva sanghs Ayurved Mahavidyalay Nashik 
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 Varsha Sadhale  Arogyashala Rugnalay Nashik  OPD No 6 Shalyatantra OPD
Nashik
MAHARASHTRA 
9822173345

shravanigirishkulkarni@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ho. Annasaheb Dange Ayurved Medical college Institutional ethical commiittee  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  OPD and IPD prediagnosed patients of sandhigata vata. 
 
ExclusionCriteria 
Details  Patients non willing .
patients having any other serious illness. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Positive corelation of Ayurvedic and Modern methods of diagnosis of Knee osteoarthritis  2 Years 
 
Secondary Outcome  
Outcome  TimePoints 
development of score based scale to know the stage of sandhigata vata.  two years 
 
Target Sample Size   Total Sample Size="310"
Sample Size from India="310" 
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)   01/04/2020 
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="1"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Prevalence of joint diseases is increasing in the society due to sedentary life style , stress  and strain in day today life. Osteoarthritis is the second most common joint disease with an  incidence rate of 22 percent to 39 percent in India. It is more common in women than men, increases dramatically with age, the prognosis worsens and finally the person ends up with joint replacement. Such chronic patients mainly approach Ayurveda to receive treatment so as to avoid the surgical interventions and to improve quality of life. Structural as well functional aspects of joints should be explored to understand the patho-physiology of joint diseases so as to decide the treatment plan. The anatomy of joint is not much explored in Ayurveda ShareerThere are mainly two types of joints i.e. cheshtavant (movable) and sthira (immovable) joints mentioned in classical textsFurther classification of joints enumerates eight types of sandhi. The eight types are namely kora, ulukhala ,samudga, pratara ,tunnasevani, vayastund, mandal,  and shankhavart. The presence of Shleshmadhara kala and shleshak kapha at all the sandhi is enumerated by Sushrutacharya..This kala along with Shleshak kapha helps  in smooth functioning of all joints . Kala are explained as limiting membranes between dhatu and ashay which is formed in intra-uterine life. Kleda between dhatu and Ashay becomes pakva and gets transformed into mucoid , tendinous and membranous structure which is known as kala..From the previous available studies it is proved that Shleshmadhara kala can be compared with synovial membrane and shleshak kapha with the synovial fluidBut this shareer about sandhi and kala explained in Ayurveda Texts is not applied in clinical practice. In various joint diseases the structural and functional changes are observed in relation to joints which affects the further prognosis of disease. In this study patients of sandhigata vata  are examined to observe such changes at various stages. Sandhigata vata mentioned by Charakacharya in chikitsasthan 28th chapter and Madhavnidan can be compared with osteoarthritis as per available literature.Understanding the pathogenesis of osteoarthritis is very important for deciding treatment plan, monitoring treatment efficacy and predicting disease outcome. Ayurveda’s approach varies from that of modern science in diagnosis of disease. Anuman Praman  is mainly used in Ayurveda  i.e. Symptomatology based on vitiation of dosha helps in accurate diagnosis of disease condition. But in modern science main emphasis is given on Pratyaksha pramana. MRI, Radiograph, Ultra sonography, Histopathological studies are used mainly to detect the structural changes in Osteoarthritis which is characterized by degenerative changes in the bones, cartilage, menisci, ligaments, and synovial tissue. Hence in this study pre diagnosed patients of sandhigata vata (osteoarthritis) having symptoms such as sandhishula (pain), sandhi shoth (inflammation), Aatop (crepitus), and Sandhigraha (stiffness)  will be selected and an attempt will be made to understand the structural changes observed in knee joint osteoarthritis with special emphasis on shleshmadhara kala along with the functional changes based on range of motion and correlation of this will be established with the symptoms .


 
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