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CTRI Number  CTRI/2022/11/047471 [Registered on: 21/11/2022] Trial Registered Prospectively
Last Modified On: 19/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   ROLE OF JANUDHARA KARMA WITH TIL TAIL (SESAME OIL) IN THE MANAGEMENT OF JANU-SANDHIVATA (KNEE OSTEOARTHRITIS) 
Scientific Title of Study   A CLINICAL STUDY OF JANUDHARA KARMA WITH TIL TAIL (SESAME OIL) IN THE MANAGEMENT OF JANU-SANDHIVATA (KNEE 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 GYAN PRAKASH SHARMA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Dr.SR Rajasthan Ayurved University Jodhpur 
Address  DSRRAU,UPGIASR, JODHPUR
PG DEPARTMENT OF PANCHAKARMA
Jodhpur
RAJASTHAN
342017
India 
Phone  9829798701  
Fax    
Email  atreyagyan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Brahmanand Sharma 
Designation  Associate Professor 
Affiliation  DSRRAU Jodhpur 
Address  PG Department of Kayachikitsa University Post Graduate Institute of Ayurved Studies and Research
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur
Jodhpur
RAJASTHAN
342037
India 
Phone  9460318138  
Fax    
Email  bkmudgal9@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR GYAN PRAKASH SHARMA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Dr.SR Rajasthan Ayurved University Jodhpur 
Address  DSRRAU,UPGIASR, JODHPUR
PG DEPARTMENT OF PANCHAKARMA
Jodhpur
RAJASTHAN
342017
India 
Phone  9829798701  
Fax    
Email  atreyagyan@gmail.com  
 
Source of Monetary or Material Support  
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur 
 
Primary Sponsor  
Name  Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur 
Address  Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur Pin 342037 
Type of Sponsor  Research institution and hospital 
 
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 
Gyan Prakash Sharma  Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, University Hospital Of Ayurved  Room no 11, Center of Excellence PG Department of Panchkarma, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar Nagaur Road Jodhpur PIN-342037
Jodhpur
RAJASTHAN 
9829798701

atreyagyan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
dsrrau  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-tailadhArA, तैलधारा (Procedure Reference: Ayurveda, Procedure details: 30 minutes per day)
(1) Medicine Name: Tila Taila, Reference: Ayurveda, Route: Topical, Dosage Form: Taila, Dose: 1000(ml), Frequency: sos, Duration: 63 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients Fulfilling The Diagnostic Criteria of Sandhigata-vata
2.Patients Age Group Between 40 to 70 Years of Both Male and Female Sex.
3. OA Grade 0 to 3 KL System (Kellgren And Lawrence System)  
 
ExclusionCriteria 
Details  1.Patients With Secondary Arthritis , Rheumatoid Arthritis, Gouty Arthritis
2.Patients Having History of Joint Trauma and Other Systemic Illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
On the Basis of-
1.Knee joint X-ray will be taken before the start of process and after the completion of process.
2.Knee Injury and Osteoarthritis Outcome Score(KOOS)
3. VAS - Visual Analogue Score for Pain Assessment

 
90 Days 
 
Secondary Outcome  
Outcome  TimePoints 
The result will be evaluated in the clinical parameter obtained before & after the completion of treatment. clinical Parameters-
1.Knee Joint X-Ray
2.Knee Injury and Osteoarthritis Outcome Score(KOOS)
3.Visual Analogue Score for Pain assessment(VAS) 
105 Days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3/ Phase 4 
Date of First Enrollment (India)   01/12/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Osteoarthritis (OA) is a long-term chronic disease characterized by the deterioration of cartilage in joints which results in bones rubbing together and creating stiffness, pain, and impaired movement.Osteoarthritis (OA) is a chronic degenerative disorder of multifactorial etiology characterized by the loss of articular cartilage, hypertrophy of bone at the margins, subchondral sclerosis, and range of biochemical and morphological alterations of the synovial membrane and joint capsule.In Ayurveda, the disease Sandhivata resembles with osteoarthritis.In the present era, modern medicines have gained wide acceptance and the knowledge regarding the disease and treatment has ascended to its peak. A lack a satisfactory regimen is not yet available in the field of health which can roll back the wear and tear of joints. So in order to obtain a permanent and safest remedy this problem will selected in the present study.This will help improve disease monitoring and help facilitate the development of medicines that can reverse the progression of this high-burden condition. Snehan and swedan  includingJanudhara both are local therapeutic procedures.According to retention of time and temperature with specific oil increase blood circulation of particular area then time of position also help to reform cartilage and  relax supporting ligament and muscles.

 

 
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