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CTRI Number  CTRI/2023/11/060355 [Registered on: 30/11/2023] Trial Registered Prospectively
Last Modified On: 23/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Ruksha Pinda Sweda in the Management of Multiple joint pain 
Scientific Title of Study   A Comparative Clinical Study to Evaluate the Therapeutic Efficacy of Different Modalities of Ruksha Pinda Sweda in the Management of Amavata W.S.R Rheumatoid Arthritis. 
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 Prathamesh Umakant Pandey 
Designation  Postgraduate Scholar 
Affiliation  G J Patel Institute of Ayurvedic Studies & Research 
Address  G J Patel Institute of Ayurvedic Studies & Research, Department of Panchakarma OPD No-15, New Vallabh Vidyanagar, Anand, Gujarat -388120

Anand
GUJARAT
388120
India 
Phone  9833372948  
Fax    
Email  prathameshpandey@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gayatri Gandhe 
Designation  Professor & HOD 
Affiliation  G J Patel Institute of Ayurvedic Studies & Research 
Address  G J Patel Institute of Ayurvedic Studies & Research, Department of Panchakarma OPD No-15, New Vallabh Vidyanagar, Anand, Gujarat -388120

Anand
GUJARAT
388120
India 
Phone  9422062452  
Fax    
Email  drgayatrigandhe@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prathamesh Umakant Pandey 
Designation  Postgraduate Scholar 
Affiliation  G J Patel Institute of Ayurvedic Studies & Research 
Address  G J Patel Institute of Ayurvedic Studies & Research, Department of Panchakarma OPD No-15 New Vallabh Vidyanagar, Anand, Gujarat -388120

Anand
GUJARAT
388120
India 
Phone  9833372948  
Fax    
Email  prathameshpandey@gmail.com  
 
Source of Monetary or Material Support  
G J PATEL INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH, DEPARTMENT OF PANCHAKARMA, NEW VALLABH VIDYANAGAR,ANAND, GUJARAT-388120 
 
Primary Sponsor  
Name  DR PRATHAMESH UMAKANT PANDEY 
Address  G J Patel Institute of Ayurvedic Studies & Research, New Vallabh Vidyanagar, Anand, Gujarat -388120 
Type of Sponsor  Other [SELF SPONSOR] 
 
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 PRATHAMESH UMAKANT PANDEY  S G PATEL AYURVEDA HOSPITAL & MATERNITY HOME  DEPARTMENT OF PANCHAKARMA OPD-15,NEW VALLABH VIDYANAGAR,ADIT CAMPUS,GIDC,ANAND,GUJARAT-388121
Anand
GUJARAT 
9833372948

prathameshpandey@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
G J Patel Institute of Ayurvedic Studies & Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-sa~gkarasvedaH, संकरस्वेदः (Procedure Reference: CHARAKA SAMHITA SUTRASTHANA SWEDADHYAYA 14/25-26, Procedure details: Group C- Ayas Pinda Sweda (20 mm iron balls) will be cleaned to ensure that it is devoid of impurities The materials will be heated up to 42 degrees using thermal gun temperature will be monitored and then tied in a double layered cloth bolus)
2Comparator ArmProcedure-sa~gkarasvedaH, संकरस्वेदः (Procedure Reference: CHARAKA SAMHITA SUTRASTHANA SWEDADHYAYA 14/25-26, Procedure details: Group A- Valuka Pinda Sweda(1.0 mm-2.0 mm size)will be cleaned to ensure that it is devoid of impurities The materials will be heated up to 42 degrees using thermal gun temperature will be monitored and then tied in a single layered cloth into bolus.)
3Intervention ArmProcedure-sa~gkarasvedaH, संकरस्वेदः (Procedure Reference: CHARAKA SAMHITA SUTRASTHANA SWEDADHYAYA 14/25-26, Procedure details: Group B- Karisha Pinda Sweda(Dry Cow Dung Coarse Powder) will be cleaned to ensure that it is devoid of impurities The materials will be heated up to 42 degrees using thermal gun temperature will be monitored and then tied in a single layered cloth bolus)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients fulfilling diagnostic criteria.
Participants satisfying 2010 ACR EULAR classification criteria for rheumatoid arthritis.
Patients having a clinical presentation of Amavata
 
 
ExclusionCriteria 
Details  Patients with major systemic illnesses like cardiac disease, uncontrolled hypertension, kidney disease, and uncontrolled diabetes mellitus.
Those who have undergone surgical treatment in affected joints.
Participants are not fit for Swedana as per Ayurvedic classics.
Participants who are suffering from Pitta- Prakopaja Conditions.
Patients who report any untoward symptoms during the period of study.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
VAS scale, 2010 ACR EULAR classification criteria for Rheumatoid Arthritis, ROM by Goniometer  1,7 & 14 Day 
 
Secondary Outcome  
Outcome  TimePoints 
Anthropometric measurement of big joints by measuring tape & Jeweler’s ring sizer
measurement for small joints. 
1,7 & 14 Day 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   10/12/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Amavata, as described in Ayurveda, is a condition resulting from factors like an incompatible diet, weak digestion, and a sedentary lifestyle, exacerbated by indulgence in unctuous foods and exercise. Ama, a product of incomplete metabolism, accumulates in the body and is driven by vitiated Vata to affect various areas, leading to symptoms like body pain, loss of appetite, fatigue, and joint-related issues.
Rheumatoid Arthritis (RA) is a systemic autoimmune disease primarily impacting joints, causing symmetrical arthritis, cartilage and bone damage. It affects approximately 1% of the world’s population, with a higher prevalence in women. Management is complex, involving medication, dietary control, and lifestyle changes, but internal medications may not always provide optimal results.
In Ayurveda, Amavata is treated with therapeutic techniques like Swedana, Langhana, and herbal preparations like Tikta-Katu Deepana. Swedana, which uses specific heated medicines, enhances metabolic activity, a key aspect of Amavata management. Ruksha Pinda Sweda, involving dry heated boluses, is commonly used, with Valuka Sweda as an ancillary treatment.
A comparative study explores alternative therapies like Karisha and Ayas Pinda Sweda’s efficacy for Amavata. Both systems, Ayurveda and modern medicine, address joint-related conditions, offering holistic and integrated approaches to improve the quality of life for those affected.

 
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