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CTRI Number  CTRI/2021/09/036744 [Registered on: 22/09/2021] Trial Registered Retrospectively
Last Modified On: 14/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical study on a multimodal Ayurvedic intervention protocol in knee joint arthritis  
Scientific Title of Study   A pre and post test clinical study on the efficacy of a multi modal intervention based on yogaratnakara treatment protocol in knee joint osteoarthritis  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SREELEKSHMI GU 
Designation  PG SCHOLAR 
Affiliation  Amrita School of Ayurveda 
Address  DEPARTMENT OF KAYACHIKITSA AMRITA SCHOOL OF AYURVEDA CLAPPANA PO KOLLAM KERALA
DEPARTMENT OF KAYACHIKITSA AMRITA SCHOOL OF AYURVEDA CLAPPANA PO KOLLAM KERALA
Kollam
KERALA
690525
India 
Phone  6282375021  
Fax    
Email  drsreelekshmisony@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr KRISHNAKUMAR K 
Designation  ASSOCIATE PROFESSOR  
Affiliation  Amrita School of Ayurveda 
Address  DEPARTMENT OF KAYACHIKITSA AMRITA SCHOOL OF AYURVEDA CLAPPANA PO KOLLAM KERALA
DEPARTMENT OF KAYACHIKITSA AMRITA SCHOOL OF AYURVEDA CLAPPANA PO KOLLAM KERALA
Kollam
KERALA
690525
India 
Phone  9446583803  
Fax    
Email  drkrishnakumarmd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr KRISHNAKUMAR K 
Designation  ASSOCIATE PROFESSOR  
Affiliation  Amrita School of Ayurveda 
Address  DEPARTMENT OF KAYACHIKITSA AMRITA SCHOOL OF AYURVEDA CLAPPANA PO KOLLAM KERALA
DEPARTMENT OF KAYACHIKITSA AMRITA SCHOOL OF AYURVEDA CLAPPANA PO KOLLAM KERALA
Kollam
KERALA
690525
India 
Phone  9446583803  
Fax    
Email  drkrishnakumarmd@gmail.com  
 
Source of Monetary or Material Support  
AMRITA SCHOOL OF AYURVEDA CLAPPANA PO KOLLAM KERALA  
 
Primary Sponsor  
Name  Amrita school of Ayurveda 
Address  DEPARTMENT OF KAYACHIKITSA AMRITA SCHOOL OF AYURVEDA CLAPPANA PO KOLLAM KERALA  
Type of Sponsor  Private 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 
SREELEKSHMI GU  Amrita school of ayurveda   DEPARTMENT OF KAYACHIKITSA CLAPPANA PO
Kollam
KERALA 
6282375021

drsreelekshmisony@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee, amrita institute of medical sciences  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: Janusandhigatavata,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  multi modal intervention on the combined efficacy of external treatments and internal medications   Duration - 30 days; First 5 days (from 1st to 5th day) - Nirgundi –karanjadi naadi swedam externally and Sthanika Nirgundi –karanjadi upanaham externally administered. Next 7 days (from 6th to 12th day) - Bahya snehana by sthanika abhyanga (external massage and lubrication therapy) and Janu pichu (cotton pad soaked in oil applied over the knee joint) with Narayana thailam , and Abhyanthara snehana (Internal lubrication) by Mathra vasthi (oil enema) with Narayana thailam (72 ml after lunch). From the 1st day to the 30th day - Shamana oushadhi (internal medicines) - Yogaraja guggulu gulika (Dose: 1 tab tds with Rasna kashaya (decoction) as Anupana - 50 ml) was given.  
Comparator Agent  No Comparator Agent  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Diagnosed according to the American College of Rheumatology criteria
2.who have OA of the knee joint
3.Radiologic changes of the knee in the images by the X ray
4.The patients will have reported a mean pain intensity in the affected knee, over the 7 days before baseline assessment
5. who are willing to give written informed consent
6. Having the lakshana of sandhigata vata as per the classic 
 
ExclusionCriteria 
Details  1.Severe deformities secondary to any other complaints like rheumatoid arthritis , gout etc.
2.Pregnant or Lactating Mothers 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The outcome expected is a change in the score on the WOMAC Index  Before and after the treatment in 30 days  
 
Secondary Outcome  
Outcome  TimePoints 
change of signs and symptoms of sandhigata vata before and after treatment  Before and after the treatment in 30 days  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/01/2017 
Date of Study Completion (India) 30/12/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Osteo arthritis is the most common joint disease of humans. Among elderly, knee joint OA is the leading cause of chronic disability in developed countries. Radiographic evidence of knee OA,is more common in women than in men1. Osteoarthritis has symptoms like Pain, Functional restriction, Joint line tenderness, Muscle wasting, mild synovitis(warmth and effusion) and Morning stiffness2. The risk factors for OA includes old age, female sex, race, genetic factors, major joint trauma, repetitive stress, obesity, congenital/developmental defects, prior inflammatory joint disease and metabolic/endocrine disorders 3. Prevalence of OA in India is reported to be in the range of 17 to 60.6% 4 . Due to the increased prevalence of this disorder it has become a major problem and burden over the society, indirectly reduces the working capacity of a citizen.

Now-a-days, even in the adult age itself man is suffering from the degenerative changes because of the changing lifestyle and food habits. The symptoms of OA is identical to the Sandhigata vata which is of degenerative and chronic rheumatic disease in nature explained by Ayurveda. This disease is known for pain & swelling in the joints giving rise to the restricted movements and disability that hampers the normal mobility which is one of the cardinal function of Vata dosha. The disease exhibits end of variety of patterns of joint failure together or lesser extent which is always characterized by degeneration of articular cartilage. It affects women than men, mainly after menopause, due to the hormonal variations.

Sandhigata vata is a type of vata vyadhi described in all classics of Ayurveda. Charaka was first to describe separately “Sandhigate-anilae” where Susrutha , Yogaratnakara, Madhava & Bhavaprakasha has described the disease as “Sandhigatavata” . The provoked Vata affects the Sandhi , which resembles a bag filled with air. Vata purna driti sparsha,Sotha,Vedana on prasarana and Akunchana are told to be the symptoms by charaka5. Being the disease of madhyama roga marga [since sandhi comes under madhyama roga marga]6 and since it is a dhatukshaya janya vyadhi 7 ,the disease becomes kashtasadhya.

The medical management now available have many limitations and cannot satisfy the objectives of an ideal therapy. Many research studies have been done but most of them have methodological limitations ,and are experimental, focusing on single herbs/ formulations, or single therapies. Full line of treatment protocol are not yet done but which is a necessity to found out , since vata is bali and ashukari, single drug or single kriya krama will be insufficient . At present era, since this degenerative disease is more prevalent, which is a cause leading to disability, there is an urgent need for an effective , safe and less complicated treatment.

 
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