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CTRI Number  CTRI/2021/10/037030 [Registered on: 01/10/2021] Trial Registered Prospectively
Last Modified On: 29/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [VIRECHANA KARMA]  
Study Design  Single Arm Study 
Public Title of Study   TO STUDY THE EFFECT OF PURGATION IN DADRU KUSHTA(TINEA CORPORIS) 
Scientific Title of Study   AN OPEN LABELLED SINGLE ARMED CLINICAL STUDY TO ASSES THE EFFICACY OF VIRECHANA KARMA IN DADRU KUSHTA(TINEA CORPORIS) 
Trial Acronym  VKDK 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M NISARGA 
Designation  PG Scholar (PANCHAKARMA) 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College and Research Centre 
Address  Department of Panchakarma ground floor Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre and Padma Ayurvedic Hospital Research Centre Sidhanth Nagar Terdal
Department of Panchakarma ground floor Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre and Padma Ayurvedic Hospital Research Centre Sidhanth Nagar Terdal
Bagalkot
KARNATAKA
587315
India 
Phone  8660592157  
Fax    
Email  mnisargam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Guralingappa Kalawwa Ankad 
Designation  Associate Professor 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College and Research Centre 
Address  Department of Panchakarma ground floor Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre and Padma Ayurvedic Hospital Research Centre Sidhanth Nagar Terdal
Department of Panchakarma ground floor Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre and Padma Ayurvedic Hospital Research Centre Sidhanth Nagar Terdal
Bagalkot
KARNATAKA
58315
India 
Phone  9482365544  
Fax    
Email  drguruankad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M NISARGA 
Designation  PG Scholar (PANCHAKARMA) 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College and Research Centre 
Address  Department of Panchakarma ground floor Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre and Padma Ayurvedic Hospital Research Centre Sidhanth Nagar Terdal
Department of Panchakarma ground floor Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre and Padma Ayurvedic Hospital Research Centre Sidhanth Nagar Terdal
Bagalkot
KARNATAKA
587315
India 
Phone  8660592157  
Fax    
Email  mnisargam@gmail.com  
 
Source of Monetary or Material Support  
SIDRAMAPPA DANIGOND MEMORIAL TRUSTS AYURVEDIC MEDICAL COLLEGE AND RESEARCH CENTRE 
 
Primary Sponsor  
Name  Self 
Address  second year post graduate scholar Department of Panchakarma ground floor Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre and Padma Ayurvedic Hospital Research Centre Sidhanth Nagar Terdal Bagalkot KARNATAKA 587315 India  
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 M NISARGA  SIDRAMAPPA DANIGOND MEMORIAL TRUSTS AYURVEDIC MEDICAL COLLEGE AND RESEARCH CENTRE   OPD AND IPD of SIDRAMAPPA DANIGOND MEMORIAL TRUSTS AYURVEDIC MEDICAL COLLEGE POST GRADUATION CENTRE AND PADMA AYURVEDIC HOSPITAL RESEARCH CENTRE SIDHANTH NAGAR TERDAL
Bagalkot
KARNATAKA 		 8660592157

mnisargam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee SDM Trusts Ayurvedic Medical College Danigond Post Graduation centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म Pradhan Karma(Procedure Reference: charaka samhitha sutra 15th and astanga hridaya sutra 18th chapter, Procedure details: DEEPANA- PACHANA -Panchakola churna 5g tid before food 3 days , SNEHAPANA-Panchatikta ghrita 5to 7 days, SARVANGA ABHYANGA- Chakramarda taila for 3days followed by bashpasweda (vishrama kala) ,VIRECHANA-Trivrut lehya ,SAMSARJANA KRAMA- According to shudhi)
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Subjects representing lakshana of dadru kushta
2.Subjects of age group 15-65yrs
3.Subjects fit for virechana
4.Subjects willing to sign consent form 
 
ExclusionCriteria 
Details  1.Subjects suffering from any chronic illness and other metabolic disorders
2.Subjects suffering from HIV/HBsAG/VDRL/STDs will be excluded
3.Pregnant and lactating women
4.Other skin manifestations 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of Virechana karma On Dadru Kushta Lakshana(SUBJECTIVE AND OBJECTIVE PARAMETERS)
SUBJECTIVE PARAMETERS:
KANDU
RUKSHATA
RAGA
OBJECTIVE PARAMETERS:
MANDALA
PIDAKA
 		 At the end of 21 Days(total time duration)
 
 
Secondary Outcome  
Outcome  TimePoints 
Hb%
T.L.C
DC
ESR
ECG(If Necessary) 		 At the end of 21 Days(total time duration)
 
 
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 2/ Phase 3 
Date of First Enrollment (India)   15/10/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   To be published after completion of the study  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This a Randomized Open Labelled Single Armed Clinical study to Assess the efficacy of Virechana Karma in Dadru Kushta(Tinea Corporis).A minimum of 30 subjects will be selected for the study. Assessment will be done on the basis of prepared proforma including subjective and objective parameters with different scales. Kushta  is a Raktapradoshaja vyadhi occurring as  result of pitta along with rakta and twak adhistana Dadru is commonly recurring skin infection and is anushangi , As Dadru kushta is tridoshaja vyadhi with predominance vitiation of pitta and kapha dosha ,Hence this study is planned to explore the role of Virechana Karma in Dadru Kushta (tinea corporis).


 
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