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
|
|
Primary Sponsor
|
Name |
Dr Varsha Sadhale |
Address |
Ayurved seva sanghs Ayurved Mahavidyalay Nashik |
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 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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
Intervention / Comparator Agent
|
|
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 Shareer. There 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 fluid. But 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 . |