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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | sa~gkarasvedaH, संकरसà¥à¤µà¥‡à¤¦à¤ƒ | (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)
| 2 | Comparator Arm | Procedure | - | sa~gkarasvedaH, संकरसà¥à¤µà¥‡à¤¦à¤ƒ | (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.)
| 3 | Intervention Arm | Procedure | - | sa~gkarasvedaH, संकरसà¥à¤µà¥‡à¤¦à¤ƒ | (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. |