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CTRI Number  CTRI/2023/06/054577 [Registered on: 30/06/2023] Trial Registered Prospectively
Last Modified On: 29/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Local application of Apamarga Kshara]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of synergetic effect of Apamarga kshar karma (locally) along with Agnikarma by Lohshalaka on Kadara with special reference to Corn.  
Scientific Title of Study   Study of synergetic effect of Apamarga kshar karma (locally) along with Agnikarma by Lohshalaka on Kadara with special reference to Corn: Randomized controlled clinical trail. 
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 Rameshwar Sitaram Bhojane 
Designation  PG SCHOLAR 
Affiliation  Government Ayurved college, Vazirabad, Nanded 
Address  Department of shalyatantra Government Ayurved College, Vazirabad, Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  9421207736  
Fax    
Email  rameshwarbhojane7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajendra H Amilkanthwar 
Designation  Associate Professor 
Affiliation  Government Ayurved college, Vazirabad, Nanded 
Address  Department of shalyatantra Government Ayurved College, Vazirabad, Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  9890569621  
Fax    
Email  drarajendrah@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajendra H Amilkanthwar 
Designation  Associate Professor 
Affiliation  Government Ayurved college, Vazirabad, Nanded 
Address  Department of shalyatantra Government Ayurved College, Vazirabad, Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  9890569621  
Fax    
Email  drarajendrah@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved college, Vazirabad, Nanded 
 
Primary Sponsor  
Name  Dr. Rameshwar Sitaram Bhojane 
Address  Department of shalyatantra, Government Ayurved College, Vazirabad Nanded 431601 
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 Rameshwar Sitaram Bhojane  Government Ayurved Hospital Nanded  Department of Shalyatantra Hospital building OPD No. 6 & 7 IPD Ward No. 51 & 63
Nanded
MAHARASHTRA 		 9421207736

rameshwarbhojane7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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
1Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Susrut Chikitsa sthan 20, Procedure details: Binduvat Agnikarma .)
2Intervention ArmProcedure-kShArakarma, क्षारकर्म Pradhan Karma(Procedure Reference: Susrut sutra 11, Procedure details: binduvat Agnikarma followed by Ksharkarma weekly.)
(1) Medicine Name: Apamarg kshar, Reference: Susruta sutra 11, Route: Topical, Dosage Form: Kshara, Dose: 1(NA), Frequency: od, Duration: 28 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient with Kadara only on foot will be included in study.
Patient with kadara eligible for ksharkarma and agnikarma will considered.
Patient who can follow given instruction and willing to give written consent to participate in the study. 
 
ExclusionCriteria 
Details  Patient who are contraindicated for agnikarma and ksharkarma.
Patients with uncontrolled systemic disorders like diabetes.
Patients with infective conditions like HIV and HBsAg were excluded.
Pregnant women. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
corn completely disappeared or cured.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.corn completely disappeared or cured.
2.reduced size of corn
3.decreased pain
4.decreased burning
5.condition of surrounding tissue improved 		 28 days 
 
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 
Date of First Enrollment (India)   07/07/2023 
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="3"
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   This study is prospective randomised open label controlled synergetic effect of apamarga ksharkarma locally along with aagnikarma by loha shalaka in kadara. Dose of apamarga kshar according to size of corn in trial group. With assessment of 0th day, 8th day, 15th day, 22nd day, 28th day. In the treatment of kadara with special reference to corn. This study conducted as pg course at single centre. The primary outcome is to study of synergetic effect of apamarga ksharkarma locally along with agnikarma by loha shalaka in kadara with special reference to corn.  
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