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CTRI Number  CTRI/2019/05/019131 [Registered on: 15/05/2019] Trial Registered Prospectively
Last Modified On: 14/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Role OF LAGHU VISHAGARBHA TAILA AND MARMA THERAPY IN THE MANAGEMENT OF SANDHIGATA VATA w.s.r. TO OSTEOARTHRITIS  
Scientific Title of Study   A Comparative Clinical Study Of Local Application OF LAGHU VISHAGARBHA TAILA AND MARMA THERAPY IN THE MANAGEMENT OF SANDHIGATA VATA w.s.r. TO OSTEOARTHRITIS”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSunil Kumar Joshi 
Designation  Professor 
Affiliation  Rishikul campus 
Address  Shalya tanra department Rishikul campus ,u.a.u ,Haridwar

Hardwar
UTTARANCHAL
249401
India 
Phone  9897523499  
Fax    
Email  mrityunjaymission@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Urvashi 
Designation  P.g scholar 
Affiliation  Rishikul campus 
Address  Department of shalya tantra Rishikul campus, u.a.u,haridwar

Hardwar
UTTARANCHAL
249401
India 
Phone  9761055936  
Fax    
Email  urvashipanwar2009@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Urvashi 
Designation  P.g scholar 
Affiliation  Rishikul campus 
Address  Department of Shalya tantra Rishikul campus, u.a.u,haridwar

Hardwar
UTTARANCHAL
249401
India 
Phone  9761055936  
Fax    
Email  urvashipanwar2009@gmail.com  
 
Source of Monetary or Material Support  
Department of Shalya tantra Rishikul ayurvedic hospital 
 
Primary Sponsor  
Name  Uttrakhand Ayurved University 
Address  Uttrakhand Ayurved Uiversity,Railway road ,Harrawala, Dehradun 
Type of Sponsor  Government 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 
Urvashi  Rishikul Ayurvedic Hospital  Department of Shalya tantra Rishikul campus, U.A.U,Haridwar
Hardwar
UTTARANCHAL 
9761055936

urvashipanwar2009@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Uttrakhnd ayurved university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M199||Osteoarthritis, unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  15 patients of this group will be treated with laghu vishagarbha taila •Mode of administration – local gentle application on the affected joint.  
Comparator Agent  Group B  15 patients will be given marma therapy. •Mode of administration – local , Thrice a day 15-18 times per sitting  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA-
1.Patients fulfilling the diagnostic criteria of Sandhigata Vata (OA)
2.Patients aged between 30 -70 years will be included of either sex.
 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA-
1.Patients having history of joint trauma, secondary and other systemic illness.
2.Patients suffering from any systemic diseases like tuberculosis, rheumatoid arthritis, gouty arthritis, psoriatic arthritis .
3.Patient suffering from infectious osteoarthritis.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Complete remission:100% relief
Markedly improved:76-99% relief
Moderately improved:51%-75% relief
Improved:26%-50% relief
Unchanged:0% – 25% relief
 
Complete remission:100% relief
Markedly improved:76-99% relief
Moderately improved:51%-75% relief
Improved:26%-50% relief
Unchanged:0% – 25% relief
 
 
Secondary Outcome  
Outcome  TimePoints 
Exacerbation in sign and symptom  90 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   20/05/2019 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Sandigata Vata is a common condition which can be correlated with osteoarthritis. Sandhigata vata  is a common type of Vatic disorder afflicting the society. Owning to distracting nature and difficult anagement ata vyadhi has been included in Asht mahagad. Osteoarthritis is a joint failure, a disease in which all structures of the joint have under gone pathology change. This is accompanied by increasing thickness and sclerosis of the subchondral bony plate, by outgrowth of osteophytes at the joint margin, by stretching of the articular capsule, by mild synovitis in many affected joints, and by the weakness of muscles bridging the joint. OA is a long term chronic disease characterized by the deterioration of cartilage in joints which result in bones rubbing together and creating stiffness, pain and impaired movement. The disease most commonly affects the joints in the knees, hands, feet, and spine and is related to ageing. It is also associated with a variety of both modifiable and non-modifiable risk factors, including obesity lack of exercise, genetic predisposition, bone density, occupational injury, trauma and gender.

 
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