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CTRI Number  CTRI/2022/09/045540 [Registered on: 15/09/2022] Trial Registered Prospectively
Last Modified On: 14/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Massage and fomentation therapy in Low back pain 
Scientific Title of Study   A Comparative Study to evaluate the Effect of Patra Pinda Sveda with Chincha Lavana Sveda in the Management of Kati Graha 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr C MUTHUNAGAI  
Designation  Postgraduate scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital Department of Panchakarma Room no 20 second floor Nazarathpet Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  9894811834  
Fax    
Email  13201b001@sjsach.org.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Chitta Ranjan Das 
Designation  Professor and H O D 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital Department of Panchakarma Room no 20 second floor Nazarathpet Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  9444123506  
Fax    
Email  drcrdayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr C MUTHUNAGAI  
Designation  Postgraduate scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital Department of Panchakarma Room no 20 second floor Nazarathpet Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  9894811834  
Fax    
Email  13201b001@sjsach.org.in  
 
Source of Monetary or Material Support  
Sri Jayendra Saraswathi Ayurveda College And Hospital 
 
Primary Sponsor  
Name  Dr C Muthunagai 
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital Department of Panchakarma Room no 20 Nazarathpet Chennai 
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 C Muthunagai  Sri Jayendra Saraswathi Ayurveda College and Hospital  Department of Panchakarma room no 20 second floor Nazarethpet Chennai
Thiruvallur
TAMIL NADU 		 9894811834

13201b001@sjsach.org.in 
 
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:M498||Spondylopathy in diseases classified elsewhere. Ayurveda Condition: Vatavyadhih,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-piNDasvedaH, पिण्डस्वेदः (Procedure Reference: Charaka samhita sutra sthana, Procedure details: Patra pinda sveda for 7 days)
2Intervention ArmProcedure-piNDasvedaH, पिण्डस्वेदः (Procedure Reference: caraka samhita sutra sthana, Procedure details: Chincha lavana sveda for 7 days)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1 Patients fit for Svedana karma
2 Patients presenting with signs and symptoms of
Kati Graha 
 
ExclusionCriteria 
Details  1 Patients with injury to Lumbar spine,traumatic and congenital deformities condition of the Spine
2 Patients complaining of radiating pain,numbness and tingling sensation.
3 Patient with skin allergies/diseases and with sensitive skin
Patient unfit for Svedana karma 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To reduce
Rujam and Sthambha
pain assessment by Defense and pain veterans scale


 		 day 22
 
 
Secondary Outcome  
Outcome  TimePoints 
Samyag swinna Lakshana  7 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   16/09/2022 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

  • Svedana is beneficial in Vata-Kaphaja disorders.Charaka included Svedana under Shadupakarma which means Svedana can be performed as pradhana karma also in various ailments independently.As per various studies conducted in different institutions across India, Patra Pinda Sveda and Chincha Lavana Pinda Sveda have been found to be very effective in the pain management. Chincha Lavana Pinda Sveda is very cost effective as compared to Patra Pinda Sveda, which is ideal for the socio-economic condition of patients across India. Considering the above fact that Chincha Lavana Pinda Sveda may be beneficial at par with Patra Pinda Sveda, a detailed comparative study of both in the context of Katigraha has to be conducted. 

 
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