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CTRI Number  CTRI/2025/04/085954 [Registered on: 29/04/2025] Trial Registered Prospectively
Last Modified On: 16/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Agnikarma using Sesame Oil for reducing pain in low back ache radiating to legs 
Scientific Title of Study   Effect of Tila Taila Agnikarma in Gridhrasi with special reference to Sciatica - An Open labelled Pre-Post Experimental Study 
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 SREELAKSHMI 
Designation  PG SCHOLAR, DEPARTMENT OF SHALYATANTRA 
Affiliation  POOMULLI NEELAKANDAN NAMBUTHIRIPADU MEMORIAL AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY. 
Address  POOMULLI NEELAKANDAN NAMBUTHIRIPADU MEMORIAL AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY P O, THRISSUR, KERALA
POOMULLI NEELAKANDAN NAMBUTHIRIPADU MEMORIAL AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY P O, THRISSUR, KERALA
Thrissur
KERALA
679531
India 
Phone  9745218467  
Fax    
Email  sree.lak16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SHAJI K 
Designation  ASSOCIATE PROFESSOR, DEPARTMENT OF SHALYATANTRA 
Affiliation  POOMULLI NEELAKANDAN NAMBUTHIRIPADU MEMORIAL AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY. 
Address  POOMULLI NEELAKANDAN NAMBUTHIRIPADU MEMORIAL AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY P O, THRISSUR, KERALA
POOMULLI NEELAKANDAN NAMBUTHIRIPADU MEMORIAL AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY P O, THRISSUR.
Thrissur
KERALA
679531
India 
Phone  9745218467  
Fax    
Email  shaji.k86@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SMITHA MOHAN P V 
Designation  HEAD OF THE DEPARTMENT, DEPARTMENT OF SHALYATANTRA 
Affiliation  POOMULLI NEELAKANDAN NAMBUTHIRIPADU AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY. 
Address  POOMULLI NEELAKANDAN NAMBUTHIRIPADU MEMORIAL AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY P O, THRISSUR, KERALA
POOMULLI NEELAKANDAN NAMBUTHIRIPADU MEMORIAL AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY P O, THRISSUR, KERALA
Thrissur
KERALA
679531
India 
Phone  9745218467  
Fax    
Email  dr.smithamohan@gmail.com  
 
Source of Monetary or Material Support  
POOMULLI NEELAKANDAN NAMBOODIRIPAD MEMORIAL AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY, THRISSUR  
 
Primary Sponsor  
Name  SREELAKSHMI 
Address  Poomulli Neelakandan Namboodiripadu Memorial Ayurveda Medical College And Hospital, Cheruthuruthy, Thrissur, Kerala  
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 SREELAKSHMI  POOMULLI NEELAKANDAN NAMBOODIRIPAD MEMORIAL AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY  OT, DEPARTMENT OF SHALYATANTRA,POOMULI NEELAKANDAN NAMBOODIRIPAD MEMORIAL AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY, THRISSUR THRISSUR KERALA 679531
Thrissur
KERALA 		 9745218467

sree.lak16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE P.N.NM 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:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: GRUDH, (2) ICD-10 Condition:M258||Other specified joint disorders. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: SUSRUTAM SUTRAM, Procedure details: MOST TENDER POINTS MARKED AND HEATED TILA TAILA TAKEN IN A BOROSSIL GLASS PIPETTE AND INSTILLED AT MARKED POINTS, MOPPED AFTER 3-4 SECONDS AND KUMARI PULP APPLIED AFTER)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion criteria
Straight Leg Raise Test Positive (45 to 90 degree)

Bragards Test Positive.
Patients with age group of 30 to 60 years. 
 
ExclusionCriteria 
Details  Exclusion criteria
Known case of Tuberculosis, fracture and malignancy of spine.
Known case of cardiac diseases.
Uncontrolled systemic diseases.
Psychic disorders.
• Contraindicated for agnikarma. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief in Ruk, Sthamba and Spandana of Gridhrasi assessed by Sciatica Bothersome Index, Gradings of Sthamba and Spandana.  Single Time Application of Snigdha Agnikarma on 1st day and post assessment on 3rd and 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
STRAIGHT LEG RAISE TEST  ASSESSED ON 1ST DAY AND POST ASSESSMENT ON 3RD AND 7TH DAY 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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 2/ Phase 3 
Date of First Enrollment (India)   06/05/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The Study is a pre-post experimental study, where there is single time application of Tila Taila Agnikarma in Gridhrasi for reducing the ruk, sthamba and spandana with special reference to Sciatica. This is an interventional study taken from reference of Susruta Samhita Sutrasthana with involvement of a single group. 
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