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CTRI Number  CTRI/2024/05/067095 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 27/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of Sama Nirama differntiation in patients with Rheumatoid Arthritis  
Scientific Title of Study   The development and validation of a diagnostic tool for sāma nirāma differentiation in patients with Rheumatoid arthritis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DurgalakshmiS 
Designation  Associate professor 
Affiliation  Amrita School of Ayurveda,, Amrita Vishwa Vidyapeetam,  
Address  Dept. Of Roganidana, Amrita School of Ayurveda, Amritapuri, Amrita Vishwa Vidyapeetam, India.
Santhinikethanam, Temple road, thiruvalla, pathanamthitta, kerala
Pathanamthitta
KERALA
690546
India 
Phone  9495701156  
Fax    
Email  dr.durgalakshmis@ay.amrita.edu  
 
Details of Contact Person
Scientific Query
 
Name  DurgalakshmiS 
Designation  Associate professor 
Affiliation  Amrita School of Ayurveda,, Amrita Vishwa Vidyapeetam,  
Address  Dept. Of Roganidana, Amrita School of Ayurveda, Amritapuri, Amrita Vishwa Vidyapeetam, India.
Santhinikethanam, Temple road, thiruvalla, pathanamthitta, kerala
Pathanamthitta
KERALA
690546
India 
Phone  9495701156  
Fax    
Email  dr.durgalakshmis@ay.amrita.edu  
 
Details of Contact Person
Public Query
 
Name  DurgalakshmiS 
Designation  Associate professor 
Affiliation  Amrita School of Ayurveda,, Amrita Vishwa Vidyapeetam,  
Address  Dept. Of Roganidana, Amrita School of Ayurveda, Amritapuri, Amrita Vishwa Vidyapeetam, India.
Santhinikethanam, Temple road, thiruvalla, pathanamthitta, kerala
Pathanamthitta
KERALA
690546
India 
Phone  9495701156  
Fax    
Email  dr.durgalakshmis@ay.amrita.edu  
 
Source of Monetary or Material Support  
Amrita school of Ayurveda,Amritapuri,Amrita Vishwa Vidyapeetam, Vallikkavu, Clappana.P.O, Kollam.  
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Durgalakshmi S  Amrita school of Ayurveda  Dept.Of Roganidana Room no 17 Vallikkavu, Clappana.P.O, Kollam Kerala India
Kollam
KERALA 
9495701156

dr.durgalakshmis@ay.amrita.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amrita school of ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M060||Rheumatoid arthritis without rheumatoid factor. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients already diagnosed as Rheumatoid Arthritis as Per 1987 Revised ACR Classification Criteria

· Subjects between age group 16 to 60 yrs.

· Patients of either sex irrespective of socioeconomic status..

· Patients fulfilling diagnostic criteria. 
 
ExclusionCriteria 
Details  History of inflammatory joint disease other than RA which might interfere the

Study e.g.; Systemic lupus erythematous, ankylosing spondylitis, osteoarthritis.

· Subject with other major systemic illness that may interfere with the study.

· Patients who were under steroid therapy.

· Patients with tumors, metabolic diseases of bone.

· Heart diseases or severe hypertension, any endocrine diseases

Such as hyperthyroidism, and severe infection 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To develop a tool for assessing Sāma and Nirāma avastha in patients with confirmed diagnosis of rheumatoid arthritis.
To assess the Sāma Nirāma avastha in patients using the developed and validated tool. 
Team meeting with experts 24 weeks
Questionnaire preparation 24 weeks
Using delphi method analysing the findings 12 weeks
Tool development and validation 9 months


 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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)   20/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/05/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
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 an immune-inflammatory systemic disorder with clinical signs and symp-toms mainly affecting synovial joints. Effective treatment of Rheumatoid arthritis has been ham-pered by the heterogeneity of the disease. Although early intervention can result in disease remis-sion, it requires early diagnosis and current diagnostic tests are not sufficiently accurate or sensitive in the early stages of RA. As a result, RA is typically diagnosed only once damage to the joints has already begun, a time at which the window for optimal treatment may have been missed. On the other hand Ayurveda Physicians do treat the patients of RA based on the Dosha evaluation and Sāma Nirāma differentiation. But there are difference of opinions among Ayurveda practitioners regarding the diagnosis, Sāma Nirāma Differentiation and management.

Concept of ama is a unique one which helped in understanding the disease and classifying the dis-ease in to sāma and nirāma avastha. In classical literature of Ayurveda, the concept of Sāmavastha and Nirāmavastha of the doshas and diseases is given importance because it plays a key role in proper management of the disease and from the diagnostic point of view. Also the line of treatment for both these stages are different from one another. Specific parameters are required to understand and confirm the prevalence of Ama, its severity and also the Nirāma stage in the body for the selec-tion of the accurate therapeutic measure. So this study is aimed to develop and evaluate a tool de-signed to understand and confirm the prevalence of Ama, its severity and also the Nirāma stage in the body which ease the task of screening and management of rheumatoid arthritis may be one of the needed interventions .The tool will be validated and grades will be included on the basis attainment of sāma nirāma lakshana.

 
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