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CTRI Number  CTRI/2024/10/075929 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 09/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Modified Churna Pinda Sweda Pottali (Herbal powder made into bolus and applied over the joint and temperature is maintained using modified equipment) and Conventional method of Churna Pinda Sweda (Herbal powder made into bolus and applied over the joint) in Amavata (Rheumatoid Arthritis) 
Scientific Title of Study   A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF MODIFIED SANKARA SWEDA IN AMAVATA 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Inchara S Gowda 
Designation  PG Scholar 
Affiliation  Alvas Ayurveda Medical College 
Address  Department of Panchakarma, Alvas Ayurveda Medical College and hospital, Vidyagiri, Moodubidire

Dakshina Kannada
KARNATAKA
574227
India 
Phone  7899075317  
Fax    
Email  incharainchara07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijayalaxmi Asundi 
Designation  Professor and HOD 
Affiliation  Alvas Ayurveda Medical College 
Address  Department of Panchakarma, Alvas Ayurveda Medical College and hospital, Vidyagiri, Moodubidire

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9995199733  
Fax    
Email  vijayalaxmiasundi4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Inchara S Gowda 
Designation  PG Scholar 
Affiliation  Alvas Ayurveda Medical College 
Address  Department of Panchakarma, Alvas Ayurveda Medical College and hospital, Vidyagiri, Moodubidire

Dakshina Kannada
KARNATAKA
574227
India 
Phone  7899075317  
Fax    
Email  incharainchara07@gmail.com  
 
Source of Monetary or Material Support  
Monetary support by Central Council for Research in Ayurvedic Sciences (CCRAS), ministry of AYUSH, govt. of India, JLNBCHA bhawan, institutional area, opp.D block Janakpuri, New Delhi, pin code 110058, Material support by Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire, Dakshina Kannada district, Karnataka, India- 574227 
 
Primary Sponsor  
Name  Alvas Ayurveda Medical College and Hospital 
Address  Outpatient department of Panchakarma, Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire, Dakshina Kannada district, Karnataka, India - 574227 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Inchara S Gowda  Alvas Ayurveda Medical College and Hospital  PG studies in the Department of Panchakarma, Alvas Ayurveda Medical college and Hospital, Vidyagiri, Moodubidire
Dakshina Kannada
KARNATAKA 		 7899075317

incharainchara07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Clinical Ethical Committee Alvas Ayurveda Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M258||Other specified joint disorders. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-svedanam, स्वेदनम् (Procedure Reference: Chakrapanidatta, Chakradatta with Vaidayaprabha Hindi Commentary, edited by Prof. Ramanath Dwivedy published by Chaukhambha Sanskrit Sansthan, Varanasi, reprint edition (2005) Chapter 25, Shloka 1, page no: 166, Procedure details: Kottamchukadi Churna is mixed with Dhanyamla and made warm, after which it is transferred to modified Sankara Sweda Pottali. The Standard SOP of Ruksha Sweda will be followed )
(1) Medicine Name: Kottamchukadi churna, Reference: Sahasra Yogam by Dr. Ramanivasa Sharma & Dr. Surendra Sharma published by Chaukhambha Sanskrit Pratistana, Delhi, page no: 295, Route: Topical, Dosage Form: Churna/ Powder, Dose: 350(g), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-svedanam, स्वेदनम् (Procedure Reference: Procedure Reference: Chakrapanidatta, Chakradatta with Vaidayaprabha Hindi Commentary, edited by Prof. Ramanath Dwivedy published by Chaukhambha Sanskrit Sansthan, Varanasi, reprint edition (2005) Chapter 25, Shloka 1, page no: 166, Procedure details: Kottamchukadi Churna is mixed with Dhanyamla & made warm, after which it is transferred to Sankara Sweda Pottali. The Standard SOP of Ruksha Sweda will be followed)
(1) Medicine Name: Kottamchukadi churna, Reference: Sahasra Yogam by Dr. Ramanivasa Sharma & Dr. Surendra Sharma published by Chaukhambha Sanskrit Pratistana, Delhi, page no: 295, Route: Topical, Dosage Form: Churna/ Powder, Dose: 350(g), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed on the basis of
classical symptoms of Amavata.
2. Patients between 20 to 60 years
irrespective of gender will be
considered.
3. Patients who are fit for Swedana.
 
 
ExclusionCriteria 
Details  1. Diseases like Vatarakta, Sandhigatavata.
2. Traumatic Pain and Swelling.
3. Patients with other Systemic disorders.
4. Patients who are on immuno suppressants
and steroids.
5. Any other condition which may interfere
directly or indirectly with my study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To check the parameters and assess the symptoms
1. Sandhi Shoola
2. Sandhi Shotha
3. Gatra Stabdata
Bilateral knee joint will be considered with or without involvement of any other joints. 		 At Day 0, Day 8, Day 15 
 
Secondary Outcome  
Outcome  TimePoints 
To check the parameters and assess the symptoms
1. Angamarda
2. Aruchi
3. Alasya
4. Gourava
5. Apaka 		 At Day 0, Day 8, Day 15
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/11/2024 
Date of Study Completion (India) 29/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="9" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (NIL).

  6. For how long will this data be available start date provided 03-12-2025 and end date provided 19-12-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   It is a comparative clinical study to evaluate the efficacy of Modified Churna Pinda Sweda equipment and conventional method of Churna Pinda sweda in Amavata. Treatment will be given for 7 days and follow up of 7 days. 20 patients in each group. That will be conducted in Alva’s Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire 
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