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CTRI Number  CTRI/2024/10/075805 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Observational study to find out the result of various Ayurveda treatment methods used for the managment of Rheumatoid Arthritis. 
Scientific Title of Study   An Observational study to explore the outcome of multimodal Ayurveda treatment in the management of Rheumatoid Arthritis a Prospective Cohort study. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Naveen Kumar 
Designation  MD Scholar,Department of Kayachkitsa 
Affiliation  All India Institute of Ayurveda  
Address  618(Seminar Hall) Department Of Kayachikitsa ,All India Institute Of Ayurveda Gautampuri Sarita vihar New Delhi South Delhi India
Gautampuri Sarita vihar New Delhi South Delhi India
South
DELHI
110076
India 
Phone  9971656859  
Fax    
Email  yadavnaveen9971@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr VG Huddar 
Designation  Additional Professor 
Affiliation  All India Institute of Ayurveda  
Address  621 Department Of Kayachikitsa All India Institute Of Ayurveda Gautampuri Sarita vihar New Delhi South DELHI India
Gautampuri Sarita vihar New Delhi South DELHI India
South
DELHI
110076
India 
Phone  9986697942  
Fax    
Email  drvghuddar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr VG Huddar 
Designation  Additional Professor 
Affiliation  All India Institute of Ayurveda  
Address  621 Department Of Kayachikitsa All India Institute Of Ayurveda Gautampuri Sarita vihar New Delhi South DELHI India
Gautampuri Sarita vihar New Delhi South DELHI India
South
DELHI
110076
India 
Phone  9986697942  
Fax    
Email  drvghuddar@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, Mathura Road, Gautam Puri Sarita Vihar, Delhi - 110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Gautampuri Sarita Vihar New Delhi 110076 
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 
Dr Naveen Kumar  All India Institute of Ayurveda   OPD no 3 andRoom no 61 6th floor ,Department of Kayachikitsa ,Gautampuri Sarita vihar New Delhi South DELHI 110076 India
South
DELHI 
9971656859

yadavnaveen9971@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) All India Institute of Ayurveda New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The patient fulfilling Diagnostic Criteria 2010 ACR (American College of Rheumatology) /EULAR (European League Against Rheumatism) criteria for RA (min. 6/10).
Raised level in one of the following biochemical Investigations RA Factor,CRP,Anti CCP,ESR , Serum Uric Acid.
Patients having classical signs and symptoms of Amavatah & Vatarakta. 
 
ExclusionCriteria 
Details  Patients having severe illness CAD ,respiratory failure, stroke etc.
Patients suffering from pre-existing systemic illnesses- CAD, uncontrolled diabetes mellitus and Hypertension , CKD, Cirrhosis, malignancies- that may jeopardise the treatment outcomes.
Patients taking DMARDs and Biologicals during the intervention period.
Patients having co-existing Autoimmune conditions – SLE, Spondyloarthropathy,
scleroderma .
Pregnant women and lactating mother.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Observing, analyse and documenting Change in CRP , ESR , RA Factor , NLR ,Uric Acid levels along with change in other objective parameters DAS28 SCORE,CDAI.
Observe the Change in Clinical symptomatology of the RA patients.
 
Day 0
Day 15
Day 30
Day 45
Day 60
Day 120
 
 
Secondary Outcome  
Outcome  TimePoints 
Observing Change in Qualty of Life of RA affected individuals.  Day 0
Day 15
Day 30
Day 45
Day 60
Day 120 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   10/11/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Rheumatoid Arthritis is a multi-system Polyarthritis connective tissue disorder causing inflammation and erosion of symmetrical smaller and larger joints characterised by pain and stiffness of synovial joints.The worldwide prevalence of the disease is approximately 1%.The disease most often affects the ages between 30 and 50 but recent studies suggests that the disease can begin in any age group.The prevalence of Rheumatoid Arthritis in India is 0.5- 3.8% in women and 0.15 - 1.35 % in men, the ratio of occurrence is 3:1.Ayurveda has mentioned classical signs and symptoms similar to RA along with various treatment principles and procedures using Panchkarma therapies and various formulations .These methods should be observed appropriately and employed in the present time to decrease the burden of disease and prevent related complications of this dreadful disease using holistic approach.Hence this study is planned to observe and document the treatment given by the Physicians in All India Institute of Ayurveda.Observation of change in subjective and objective parameters in the current clinical practise will be documented .This study provide scope for further research areas by paving a way to develop treatment protocols to tackle this dreadful Autoimmune disorder.

 
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