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CTRI Number  CTRI/2024/12/078237 [Registered on: 17/12/2024] Trial Registered Prospectively
Last Modified On: 10/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Fatigue in inflammatory arthritis 
Scientific Title of Study   Systemic Clinical Features of Shukrakshaya in Amavata (Inflammatory Polyarthritis) 
Trial Acronym  None 
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 Ayurved and Research Centre, Pimpri, Pune
Pimpri, Pune 411018
Pune
MAHARASHTRA
411018
India 
Phone  9822032373  
Fax    
Email  sywagh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinayak N Joshi 
Designation  HOD, Guide 
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 Ayurved and Research, Pimpri, Pune
Pimpri, Pune 411018
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 Ayurved and Research, Pimpri, Pune
Pimpri, Pune 411018
Pune
MAHARASHTRA
411018
India 
Phone  9822032373  
Fax    
Email  sywagh@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Dr Shrikant Wagh 
Address  Lupus Clinic, 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 
Shrikant Wagh  Dr. Shrikant Wagh  Lupus Clinic, Tejas Apartment, 1st Floor, 1078, Shukrawar Peth, Tilak Road, Pune 411002
Pune
MAHARASHTRA 		 09822032373

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 a  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M058||Other rheumatoid arthritis with rheumatoid factor. 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  1. Patients with five or more painful and swollen joints
2. Age above 18 years
3. Patients who sign the informed consent form and willing to give correct information
 
 
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 990 F)
5. Neurological disorders that limit the 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. Long-acting glucocorticoids or disease modifying antirheumatic drugs during previous three months
9. Nonsteroidal anti-inflammatory drugs or glucocorticoids within previous 24 hours of examination
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation between shukrakshaya and severity of ama in the patients of inflammatory polyarthritis (amavata) and correlation between disease activity and severity of shukrakshaya in the these patients.  Single visit (Cross-sectional study) 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   01/01/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Introduction

Rheumatoid arthritis (RA) is a prototype of amavata. Ama is one of the causes of dhatukshaya which is not mentioned in the listed features of amavata. No studies attempt to establish the association of dhatukshaya in amavata. Shukrakshaya can be assessed by the presence of clinical features and the FACIT fatigue scale. A preliminary study is, therefore, planned to understand the association of amavata and shukrakshaya. 

Materials and Methods

A minimum of 25 OPD patients suffering from amavata (RA as per ACR/EULAR criteria 2010) will be studied at Lupus Clinic, Pune 411002. Clinical features of amavata including their severity, and the features of ama and its severity (assessed by validated instrument) will be studied along with features of shukrakshaya described in Ayurveda viz. anaemia (complete hemogram), dry mouth (short xerostomia inventory), and FACIT fatigue scale* along with Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale (for weakness, tiredness, and fatigue).  

Outcome

Analysis and interpretation of study findings to know the correlation between the clinical features of amavata (RA) and features of shukrakshaya viz. anaemia, dry mouth, and fatigue. The results will be disseminated on an appropriate platform (conference paper/journal article)

*License for use of FACIT (English and Marathi versions obtained on 16th September 2024)

 

 
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