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CTRI Number  CTRI/2025/04/083802 [Registered on: 01/04/2025] Trial Registered Prospectively
Last Modified On: 28/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of Agnikarma by Tapta Tilataila and Ksharakarma by Apamarga Pratisarneeya Kshara in the management of Corn 
Scientific Title of Study   A Randomized Comparative Clinical Study to evaluate the efficacy of Agnikarma by Tapta Tilataila and Ksharakarma by Apamarga Pratisarneeya Kshara in the management of Kadara with special reference to Corn 
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 Summayyaanjuma Muchale 
Designation  PG Scholar shalyatantra 
Affiliation  BVVS Ayurveda Medical College and Hospital Bagalkot 
Address  Department of Shalyatantra BVVS Ayurveda Medical College and Hospital Bagalkot
BVVS Ayurveda Medical College and Hospital Bagalkot
Bagalkot
KARNATAKA
587101
India 
Phone  7760561943  
Fax    
Email  sumaiyyamuc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pallavi A Hegde 
Designation  Professor 
Affiliation  BVVS Ayurveda Medical College and Hospital Bagalkot 
Address  Department of Shalyatantra BVVS Ayurveda Medical College and Hospital Bagalkot
BVVS Ayurveda Medical College and Hospital Bagalkot
Bagalkot
KARNATAKA
587101
India 
Phone  9448636321  
Fax    
Email  drpallaviah@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mallikarjun S Hiremath  
Designation  Incharge Principal and Professor 
Affiliation  BVVS Ayurveda Medical College and Hospital Bagalkot 
Address  Department of Rachana Sharir BVVS Ayurveda Medical College and Hospital Bagalkot 587101

Bagalkot
KARNATAKA
587101
India 
Phone  9482631399  
Fax    
Email  malikdost4u@gmail.com  
 
Source of Monetary or Material Support  
BVVS Ayurved Medical College And Hosital Bagalkot Karnataka India 587101 
 
Primary Sponsor  
Name  BVVS Ayurveda Medical College And Hospital  
Address  Department of shalyatantra BVVS Ayurveda Medical College and Hospital Bagalkot Karnataka India 587101 
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 Summayyaanjuma Muchale  BVVS Ayurveda Medical College and Hospital   Department of shalyatantra BVVS Ayurveda Medical College and Hospital BVVS Campus Bagalkot Karnataka India 587101
Bagalkot
KARNATAKA 
7760561943

sumaiyyamuc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC BVVS Ayurveda Medical College and Hospital Bagalkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L84||Corns and callosities. Ayurveda Condition: KADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushruta samhita sutrasthana 12th chapter, Procedure details: Lekhana will be carried daily before Agnikarma .The taila is heated to the temperature of toleration capacity of the patient & will be dribbeled over the site of Kadara with the dropper per sitting. Taila will be kept in situ with the Pali constructed around Kadara till it gets cooled. )
(1) Medicine Name: Tapta tila taila, Reference: sushruta samhita sutrasthana 12th chapter, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: sushruta samhita sutrasthana chapter 11, Procedure details: Lekhana karma will be carried before application of ksharakarma.Pratisarana of Apamarga Kshara will be done on Kadara with the help of Shalaka Yantra left in situ for Shata Matra Kala.)
(1) Medicine Name: apamarga pratisaraniya kshara, Reference: sushruta samhita sutrastana chapter 11, Route: Topical, Dosage Form: Kshara, Dose: 2(g), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion Criteria
Diagnosed Patients of Kadara (Corn) of either gender.
Patients of Kadara with age group between 18 to 60 years.
Patients with single or multiple corn.
Patients of Kadara with controlled hypertension and diabetes mellitus 
 
ExclusionCriteria 
Details  Patients with infected corn.
Patients of Kadara with retroviral disease or HBsAg.
Pregnant and Lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To know the efficacy of Agnikarma by Tapta Tilataila and Ksharakarma by Apamarga Pratisarneeya Kshara in the management of Kadara with special reference to Corn   7 days 
 
Secondary Outcome  
Outcome  TimePoints 
AIM:
1.To compare the efficacy of Agnikarma with Tapta Tilataila and Ksharakarma with Apamarga Pratisaraneeya Kshara in the management of Kadara with special reference to Corn.
OBJECTIVES:
2.To evaluate the efficacy of Agnikarma with Tapta Tilataila in the management of Kadara with special reference to Corn .
3.To evaluate the efficacy of Ksharakarma with Apamarga Pratisaraneeya Kshara in the management of Kadara with special reference to Corn . 
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 2 
Date of First Enrollment (India)   10/04/2025 
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 Yet Recruiting 
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  

            India is an agriculture based country, where 20% of  total population lives in urban areas where as rest 80% living in rural. As it is developing country, where most of the population rely on manual labor either for agriculture or construction and such other means of livelihood. Due to poor protective measures, ignorance, negligence and poor economic status, chances of developing foot and palm lesions are quite high, most common lesion which is seen in feet is corn .The incidence of corns on the feet has been reported to be ranging anywhere from 14% to 48%. They have been reported to affect older age groups with a slight female predominance due to wearing narrow shoes. The elderly are also subject to loss of the protective fat pad cushioning, called fat pad atrophy, which can increase the incidence of painful corn. Corn is localized hyperkeratosis of the skin, it usually occurs at the sites of pressure e.g. on sole and toes. There is usually a horny induration of the cuticle with a hard centre. Corn may be painful particularly when it is rubbed. A corn has deep central core which reaches the deeper layers of dermis.
Acharya Sushruta has explained 44 types of Kshudra Rogas in Nidana Sthana, in which Kadara is one, that is caused due to injury by Sharkaraadi (soil, pebble, stone) or Kanthaka (thorn prick) while walking. This leads to aggravation of Dosha, and these Doshas  flow through Meda and Rakta, giving rise to Granthi (tubercle), which is Sakeela Kathina  (hard like a bolt) , Nimna Madhya Unnata (depressed at the edges and elevated in middle) of feet ,of the size of Kola (jujuba fruit)  having pain and exudation.
           Acharya Sushruta in Chikitsasthana explained about Kadara Chikitsa in Kshudra Roga Chikitsa Adhaya where he mentioned Utkartna followed by Sneha Dahana. Acharya Sushruta in Kshara Pakavidhi Adhyaya explained its benefits on various Twak Vikara including Kshudra Rogas. Kshara is mentioned as Pradhana as compared to Shastra and Anushastra by its properties of Chedana, Bhedana, Lekhana Karma. Further Pratisarneeya  Kshara is indicated in Twakagata Vikara.While in the context of Agnikarmavidhi Adhyaya, Acharya Sushruta explained that Agni Karma is more effective than Kshara Karma because of its Apunarbhava quality, and the Rogas which cannot be managed by Aushadhi, Shastra and Kshara Karma can be managed by Agnikarma. Various Dahanopakarana are mentioned as per the Dhatu involvement, where Sneha can be used for Sira Snayugata Roga’s. Acharya Charaka in Grahani Chikitsa Adhyaya explained about Dhatu and Upadhatu where he mentions Sira, Khandara as Upadhatu of Rakta and Snayu as Upadhatu of Meda. As in Kadara, Meda and Rakta are vitiated Snehadahana can be considered. 
In allied science conservative measures for management of corn are salicylic acid in collodion on successive nights may be applied or central local applications have been effective such as carnation cap. Corn has tendency to recur. Preventive measures such as using soft shoes or soft pads at pressure point of the sole. If preventive measures fail and corn is painful, it should be excised with particular care to take off the deep root of the central core. This often prevents reccurence.
Acharya Sushruta explains the management of Kadara by Utkartana followed by Sneha Dahana. Acharya Sushruta explained Tilataila qualities as  Ushna, Vyavayi, Sukshma, Vishada, Vikasi, Twakprasadana .Hence Tilataila is taken as Sneha Dravya for the Dahanakarma at Kadara site.
  Acharya Bhavaprakasha explained the Rasa of Apamarga as Katu, Tikta; Tikshna Gunatmaka; Ushna Virya; Katu Vipaka; Kapha Vatahara, Shoolahara, Medohara,  Vranhita and Twachya in action.By the previous research works Apamarga Pratisarneeya Kshara is taken as standard for the study. 
The procedure can be carried on OPD basis. There is no creation of wound, hence  needs no anaesthesia, antibiotics and analgesics. The procedure will not hamper individuals routine activities and the time taken by Agnikarma or Ksharakarma in corn management is minimal when compared to the wound healing rate which ranges from few weeks to month after excision. 
         Hence the present study is undertaken to compare the efficacy of Agnikarma with Tilataila and  Ksharakarma with Apamarga Pratisarneeya Kshara in the management of Kadara with special reference to Corn .”
 
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