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CTRI Number  CTRI/2025/01/079317 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 03/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of tongue coating in Rheumatoid Arthritis 
Scientific Title of Study   Correlation between Jivha Samata (coated tongue) and Disease Activity in cases of Amavata (Rheumatoid Arthritis): a Cross-sectional Study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
None  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Shrikant Wagh 
Designation  Ph D Scholar 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre  
Address  Department of Rognidan and Vikruti-vigyan, 2nd floor, Dr D Y Patil College of Ayurveda and Research Centre, Pimpri, Pune
Lupus Clinic, Centre for Arthritis and Rheumatism, 1078, Shukrawar Peth, Tilak Road, Pune 411002
Pune
MAHARASHTRA
411018
India 
Phone  9822032373  
Fax    
Email  sywagh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinayak N Joshi 
Designation  Guide 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre  
Address  Department of Rognidan and Vikruti Vigyan, 2 nd floor, Dr D Y Patil College of Ayurved and Research Centre, Pimpri, Pune
Lupus Clinic, Centre for Arthritis and Rheumatism, 1078, Shukrawar Peth, Tilak Road, Pune 411002
Pune
MAHARASHTRA
411018
India 
Phone  8275648036  
Fax    
Email  vinayak.doctor@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Shrikant Wagh 
Designation  Ph D Scholar 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre  
Address  Department of Rognidan and Vikruti-Vigyan, 2nd floor, Dr D Y Patil College of Ayurveda and Research Centre, Pimpri, Pune
Lupus Clinic, Centre for Arthritis and Rheumatism, 1078, Shukrawar Peth, Tilak Road, Pune 411002
Pune
MAHARASHTRA
411018
India 
Phone  9822032373  
Fax    
Email  sywagh@gmail.com  
 
Source of Monetary or Material Support  
Monetary Support: Nil Material Support: (OPD patients at) Lupus Clinic, Centre for Arthritis and Rheumatism, 1078, Shukrawar Peth, Tilak Road, Pune 411002 
 
Primary Sponsor  
Name  Dr Shrikant Wagh 
Address  Lupus Clinic, Centre for Arthritis and Rheumatism, 1078, Shukrawar Peth, Tilak Road, Pune 411002 
Type of Sponsor  Other [Self] 
 
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 Shrikant Wagh  Lupus Clinic  Tejas Apartment, First Floor, 1078, Shukrawar Peth, Tilak Road, Pune 411002.
Pune
MAHARASHTRA 		 9822032373

sywagh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. D. Y. Patil College of Ayurved and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Group A:
1.Patients who fulfil ACR/EULAR 2010 criteria for diagnosis of RA
2.Age above 18 years
3.Patients who sign the informed consent form
Group B:
1.Patients of RA who are in remission (CDAI less than 2.8)
2.Age above 18 years
3.Patients who sign the informed consent form
 
 
ExclusionCriteria 
Details  1. Pregnancy
2. Post-partum period (up to nine months)
3. Joint pain and swelling following trauma
4. Patients with fever (axillary temperature more than 99 degrees F)
5. Neurological disorders that limit mobility e. g., hemiplegia, paraplegia, Parkinsonism, lumbar canal stenosis
6. History of endocrine disorders e.g., diabetes mellitus, hypothyroidism
7. History of chronic gastrointestinal disorder e.g., GERD, inflammatory bowel disease
8. Use of drugs
Group A:
I) Long-acting glucocorticoids or disease modifying antirheumatic drugs during previous three months
ii) Nonsteroidal anti-inflammatory drugs or glucocorticoids within previous 24 hours of examination
Group B:
I. Nonsteroidal anti-inflammatory drugs or glucocorticoids within previous 24 hours of examination

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation between Coating (Samata) of tongue and Clinical Disease Activity Index in patients with Rheumatoid Arthritis (Amavata)  Single patient visit (cross-sectional study) 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="22" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/02/2025 
Date of Study Completion (India) 31/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Published. Journal of Ayurveda and Integrative Medicine Volume 17, Issue 3, May–June 2026, 101315 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Tongue examination is described in Ayurveda (eight-fold examination of patient) as well as Unani, Siddha, Korean, Greek, and Traditional Chinese Medicine. Clinicians of Ayurveda often examine jivha-samata (tongue-coating) in ama-related conditions. Severity of tongue-coating can be clinically assessed by Winkel tongue coating index (WTCI) using analysis of smart-phone images by experienced clinicians. An observational study is planned to study the association of tongue-coating and disease severity (assessed by Clinical Disease Activity Index – CDAI) as well as the severity of ama evaluated by validated ama-instrument in patients with Rheumatoid arthritis (RA) as a prototype of amavata.

Primary Objective

To study the correlation between sam-jivha (WTCI) and CDAI in the patients of amavata (RA) with the help of analysis of smartphone-captured photographs of the tongue. 

Secondary Objectives

1.      To evaluate the relation between the ama instrument and severity of sam-jivha (WTCI) in the patients with amavata (RA)

2.      To identify inter-rater reliability in the assessment of sam-jivha (WTCI) in the patients with amavata (RA).

Materials: Consecutive out-patients suffering from RA divided in two groups: Treatment naïve patients with active RA, and patients of RA in remission as defined by CDAI (less than 2.8) (15 subjects in each group)

Place of study: Lupus Clinic, Tilak Road, Pune 411002

Methods: Subjects of RA diagnosed as per ACR/EULAR criteria (2010) will be assessed for disease activity (CDAI), and severity of ama assessed by validated ama-instrument. A photograph of tongue obtained by smartphone using standard procedure will be assessed by at least three expert clinicians for WTCI. The data will be analyzed and interpreted for drawing conclusions. The conclusions will be disseminated in appropriate publications. 

 
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