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CTRI Number  CTRI/2025/03/083719 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 27/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFFICACY OF MRUTTIKA SHALAKA AND PANCHA LOHA SHALAKA IN VATAKANTAKA (CALCANEAL SPUR)  
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF MRUTTIKA SHALAKA AND PANCHA LOHA SHALAKA AGNIKARMA IN THE MANAGEMENT OF VATAKANTAKA (CALCANEAL SPUR) 
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 Kumar Athani 
Designation  PG Scholar 
Affiliation  SDM Trust s Ayurvedic Medical College Danigond Post Graduation Centre 
Address  SDM Trust s Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital and Research Centre Terdal 587315 Karnataka

Bagalkot
KARNATAKA
587315
India 
Phone  9902895381  
Fax    
Email  drkumarathani1985@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S L Balareddy 
Designation  PROFESSOR 
Affiliation  SDM Trust s Ayurvedic Medical College Danigond Post Graduation Centre 
Address  SDM Trust s Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital and Research Centre Terdal 587315 Karnataka
SDM Trust s Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital and Research Centre Terdal 587315 Karnataka
Bagalkot
KARNATAKA
587315
India 
Phone  9669082297  
Fax    
Email  Shivabalaraddi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kumar Athani 
Designation  PG Scholar 
Affiliation  SDM Trust s Ayurvedic Medical College Danigond Post Graduation Centre 
Address  SDM Trust s Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital and Research Centre Terdal 587315 Karnataka

Bagalkot
KARNATAKA
587315
India 
Phone  9902895381  
Fax    
Email  drkumarathani1985@gmail.com  
 
Source of Monetary or Material Support  
Dr Kumar Athani SDM Trust s Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital and Research Centre Terdal 587315 Karnataka 
 
Primary Sponsor  
Name  Dr Kumar Athani 
Address  SDM Trust s Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital and Research Centre Terdal 587315 Karnataka 
Type of Sponsor  Private medical college 
 
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 Kumar Athani  SDMTs ayurvedic college and hospital terdal  SDMTs ayurvedic college and hosptal Padma hospital ptsr department room no 3 floor no 2 terdal padma nagar 587315 Bagalkot KARNATAKA
Bagalkot
KARNATAKA 		 9902895281

drkumarathani1985@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDMTs AYURVEDIC MEDICAL COLLEGE AND PADMA AYURVEDIC HOSPITAL INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M799||Soft tissue disorder, unspecified. Ayurveda Condition: VATAKANTAKAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-agnikarma, अग्निकर्म Pradhan Karma(Procedure Reference: Sushruta Samhita of Sushrutani- dansthan: chapter 1 (Vatavyadhi Nidana), verse 79. Varanasi: chaukhambha Sanskrit - sansthan, 2016; p. 304., Procedure details: Point of maximum tenderness will be identified Then affected part will be cleaned with distilled water Then it will be wiped with dry cotton gauze Then appropriate Shalaka will be heated by direct method with the help of heating element Samyaka Dagdha Varna will be made by heated Shalaka Samyaka Dagdha Lakshana will be observed 1 time/ day)
2Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: agnikarma with mrutika shalaka, Procedure details: (Procedure Reference: Sushruta Samhita of Sushrutani- dansthan: chapter 1 (Vatavyadhi Nidana), verse 79. Varanasi: chaukhambha Sanskrit - sansthan, 2016; p. 304., Procedure details: Point of maximum tenderness will be identified Then affected part will be cleaned with distilled water Then it will be wiped with dry cotton gauze Then appropriate Shalaka will be heated by direct method with the help of heating element Samyaka Dagdha Varna will be made by heated Shalaka Samyaka Dagdha Lakshana will be observed 1 time/ day) )
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The patients between the age group of (18-60) years
Patients clinically diagnosed with sign and symptoms of Vatakantaka (calcaneal spur) like Shoola difficulty in walking 
 
ExclusionCriteria 
Details  Patient with wound on heel region
Calcaneal fracture
Patients with diabetic foot
Immunocompromised patients
Patient with impaired blood circulation to lower extremities
Pregnant women
Diabetic Mellitus & Hypertension
Patient who are receiving anti Platelet drugs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of Agnikarma with Mruttika Shalaka in the management of
Vatakantaka (Calcaneal spur) 		 1st day and 7th day, 2 sittings. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of Agnikarma with Mruttika Shalaka & Panchaloha Shalaka in the management of Vatakantaka (Calcaneal spur)  1st 7th 14th 30th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/03/2026 
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="0"
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 Calcaneum is largest bone of foot which forms major part of skeleton of foot which provides posterior support for bony arches. Calcaneal spur is bony over growth from Calcaneum bone it may be due to over calcium deposition which is painful condition of heel.
The patients between the age group of 18-60 years.
Patients clinically diagnosed with sign and symptoms of Vatakantaka (calcaneal spur) like Shoola, difficulty in walking.
To evaluate the effect of Agnikarma with Mruttika Shalaka in the management of Vatakantaka (Calcaneal spur).
 
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