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CTRI Number  CTRI/2024/02/063232 [Registered on: 28/02/2024] Trial Registered Prospectively
Last Modified On: 25/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Combination of Ayurvedic and Modern medicine in treatment of early rheumatoid arthritis 
Scientific Title of Study   Assessment of efficacy of methotrexate with ayurvedic preparation (Singhnad guggul, Rasna saptak kwath, Erand oil) versus methotrexate with placebo in early rheumatoid arthritis: an exploratory double-blind randomized placebo-controlled trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prativa Priyadarshani Sethi 
Designation  Senior Resident 
Affiliation  All India Institute of Medical sciences, Rishikesh 
Address  Department of General medicine, Level 6, Academic Block, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9040502676  
Fax    
Email  prativa703@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Venkatesh S Pai 
Designation  Additional Professor 
Affiliation  All India Institute of Medical sciences, Rishikesh 
Address  Department of General Medicine, Level 6 , Academic Block, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9040502676  
Fax    
Email  drsvpai@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Prativa Priyadarshani Sethi 
Designation  Senior Resident 
Affiliation  All India Institute of Medical sciences, Rishikesh 
Address  Department of General Medicine, Level 6, Academic Block, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9040502676  
Fax    
Email  prativa703@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India, 249203 
 
Primary Sponsor  
Name  Prativa Priyadarshani Sethi 
Address  Department of General Medicine, Level 6, Academic Block, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, 249203 
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 Prativa Priyadarshani Sethi  All India Institute of Medical Sciences, Rishikesh  Division of Clinical Immunology & Rheumatology, AIIMS, Rishikesh, Uttarakhand, 249203, India
Dehradun
UTTARANCHAL 		 9040502676

prativa703@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Rishikesh, Institutional Ethics Committee  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, (2) ICD-10 Condition: M056||Rheumatoid arthritis with involvement of other organs and systems, (3) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, (4) ICD-10 Condition: M060||Rheumatoid arthritis without rheumatoid factor,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Singhnad Guggul, Reference: Ayurvedic Formulary of India, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -Singhnad guggul will be provided in capsule formulation to patients in intervention arm.
(2) Medicine Name: Rasna saptak kwath, Reference: Ayurvedic Formulary of India, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - 10gm of kwath churna will be reconstituted with 40ml of water and will be made into 20ml of liquid formulation and will be consumed twice daily.
(3) Medicine Name: Erand oil, Reference: Ayurvedic Formula, Route: , Dosage Form: Kwatha/ Kashaya, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Singhnad Guggul placebo, Reference: Ayurvedic Formulary of India, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -Placebo will be prepared from powdered Bengal gram and will be provided in similar looking capsules as that of intervention group.
(2) Medicine Name: Rasna saptak kwath, Reference: Ayurvedic Formulary of India, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -Placebo will be prepared from powdered Erandmool and gilloi. Active ingredient will be pre extracted and remaining powdered mix
Intervention  Methotrexate Singhnad guggul Erand oil Rasnasapthak kwath Panchakola churna  Panchakola churna 2gm twice daily x 7days Erand oil 10-20ml x 5-7days( as decided by ayurvedic physician) Tab Methotrexate 15mg(maximum 25mg) once weekly x 24 weeks Capsule Singhnad guggul 500mg twice daily for 24weeks (from day 8) Rasana Saptak Kwath 10gm (made into liquid) once daily x 1 month(first 4 weeks)  
Comparator Agent  placebo+ Methotrexate  Methotrexate 15mg( maximum 25mg / week) Placebo of Panchkol churan 2gm twice daily x 7days Placebo of Erand oil 10-20ml once daily x 5-7days Placebo capsule Singhnad guggul 500mg Twice daily from day 8 to 24 weeks Placebo Rasna sapthak kwath 10gm( made into liquid) once daily x 1month  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  age more than 18years, early RA within 1 year of diagnosis
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
DAS28ESR ≤3.2
DAS28CRP ≤3.2 		 Baseline and 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
DAS28ESR ≤ 2.6
DAS28CRP ≤ 2.6
ACR 20, 50, 70 RESPONSE
EULAR RESPONSE
HAQ-DI (Indian Version)
ANY SYMPTOMATIC ADVERSE EVENT
TLC ≤ 4000/mm3
platelet ≤ 1,00,000/mm3
AST/ALT ≥ 80 IU/L
 		 Baseline & 24 weeks  
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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   Phase 3 
Date of First Enrollment (India)   10/03/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 (Others) -  Data will be made available on appropriate request on PI email ID-prativa703@gmail.com

  6. For how long will this data be available start date provided 01-06-2025 and end date provided 31-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Rheumatoid arthritis (RA) is a chronic autoimmune disorder affecting small joints. Mortality and morbidity rates are higher due to cardiovascular events. Early, aggressive treatment with disease-modifying anti-rheumatic drugs (DMARDs) is crucial. Ayurveda, an ancient Indian system, is being explored as an adjunct therapy. While some studies support its efficacy, others are inconclusive. Meta-analyses suggest combining Ayurveda with conventional DMARDs improves pain, function, and inflammation. The aim of this study is to investigate whether combination of methotrexate with ayurvedic preparation (Singhnad guggul, Rasna sapthak kwath, Erand oil) would result in better efficacy compared to methotrexate alone among patients with early rheumatoid arthritis over 24 weeks. We hypothesize that Methotrexate with Ayurveda will yield better responses and low disease activity at 24 weeks than methotrexate alone.  


 
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