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CTRI Number  CTRI/2022/07/044348 [Registered on: 26/07/2022] Trial Registered Prospectively
Last Modified On: 07/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical higher investigation of Rheumatoid Arthritis patients receiving Ayurvedic therapy.  
Scientific Title of Study   Clinical Metabolomics investigation of Rheumatoid Arthritis patients receiving Ayurvedic whole system intervention  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankita Verma 
Designation  Research Scholar 
Affiliation  State Ayurvedic College and Hospital, Lucknow  
Address  Department of Kaya Chikitsa, State Ayurvedic College and Hospital, Lucknow
State Ayurvedic College, Tulsi Das Marg, Lucknow
Lucknow
UTTAR PRADESH
226003
India 
Phone  8052772926  
Fax    
Email  ankitavermadr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjeev Rastogi 
Designation  Head of Department 
Affiliation  State Ayurvedic College and Hospital, Lucknow  
Address  Department of Kaya Chikitsa, State Ayurvedic College and Hospital, Lucknow
State Ayurvedic College, Tulsi Das Marg, Lucknow
Lucknow
UTTAR PRADESH
226003
India 
Phone  9415022955  
Fax    
Email  rastogisanjeev@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Ankita Verma 
Designation  Research Scholar 
Affiliation  State Ayurvedic College and Hospital, Lucknow  
Address  Department of Kaya Chikitsa, State Ayurvedic College and Hospital, Lucknow
State Ayurvedic College, Tulsi Das Marg, Lucknow
Lucknow
UTTAR PRADESH
226003
India 
Phone  8052772926  
Fax    
Email  ankitavermadr@gmail.com  
 
Source of Monetary or Material Support  
State Ayurvedic College and Hospital Lucknow 
 
Primary Sponsor  
Name  State Ayurvedic College and Hospital Lucknow 
Address  State Ayurvedic College and Hospital, Lucknow, 226003 
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 
Ankita Verma   State Ayurvedic College and Hospital, Lucknow   Kayachikitsa Department/OPD No. 10 (Saturday)/ Arthritis Treatment & Advanced Research Center OPD (Monday & Wednesday)
Lucknow
UTTAR PRADESH 		 8052772926

ankitavermadr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement. Ayurveda Condition: AMAVATAH, (2) ICD-10 Condition:M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Amawatari Ras, Reference: Bhaisahajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -AYURVEDIC WHOLE SYSTEM INTERVENTION FOR 90 DAYS.
(2) Medicine Name: Ajmodadi Churna, Reference: Ayurveda Sara Sangraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -AYURVEDIC WHOLE SYSTEM INTERVENTION FOR 90 DAYS.
(3) Medicine Name: Panchakol Churna, Reference: Chikitsa Sara Sangraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -AYURVEDIC WHOLE SYSTEM INTERVENTION FOR 90 DAYS.
(4) Medicine Name: Sinhanad Guggul, Reference: Chakradatta, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients not in remission state as per DAS-28 ESR criteria. 
 
ExclusionCriteria 
Details  Having co-morbid conditions like Osteoarthritis, Gout etc. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical metabolomic assessment and clinical outcome among the people registered under the study following the Ayurvedic whole system intervention will be done through DAS-28 ESR scoring. Final assessment will be done with the help of ACR20, ACR50 and ACR70 criteria. This clinical outcome assessment will be supplemented by quantitative evaluation of inflammatory markers like ESR/CRP.   12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life improvement.  12 weeks 
 
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)   01/08/2022 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [Ankitavermadr@gmail.com].

  6. For how long will this data be available start date provided 09-01-2023 and end date provided 09-01-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Rheumatoid Arthritis (RA) is an autoimmune musculoskeletal disorder having a high prevalence and debility potential. Its treatment conventionally aims at early diagnosis followed by symptom management, deformity and joint destruction prevention, restoration of joint mobility and quality of life improvement. ’Clinical Metabolomic’ in RA is one step head of conventional assessment done through clinical observations generic biomarkers like ESR & CRP. Purpose of this study is to find if there are any meaningful differences among ’RA related disease activity specific metabolites’ in sample population of RA receiving ayurvedic whole system intervention considering its own method of diagnosis & treatment selection. Intervention will be given for 3 months. A 2 weekly follow-up will be done for the purpose of clinical records. Metabolomics will be performed only pre and post i.e., at the time of registration & after completion of trial. A patient population of 30 RA considering the single group & pragmatic nature of the study having a simultaneous diagnosis of Amavata and receiving specific ayurvedic comprehensive interventions (whole system approach) for 3 months will be evaluated clinically on the basis of DAS-28 score changes and will be categorized for level of improvements as ACR20, ACR50 or ACR70. This clinical outcome assessment will be supplemented by quantitative evaluation of inflammatory markers like ESR/CRP. 
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