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CTRI Number  CTRI/2025/07/091464 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 27/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   IN THIS CLINICAL TRIAL RANDOM PEOPLE WITH DADRU KUSHTA WILL BE SELECTED TO TEST VISHA TAILA LEPA APPLICATION FOR TREATMENT 
Scientific Title of Study   A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECT OF VISHATAILA LEPA IN DADRU KUSTHA W.S.R TO TINEA CORPORIS 
Trial Acronym  DADRU 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SANDEEP 
Designation  PG SCHOLAR  
Affiliation  SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE 
Address  DEPARTMENT OF KAYACHIKITSA, SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE, LAXMINAGAR, KUTHAPADY, UDUPI, KARNATAKA, INDIA 574118

Udupi
KARNATAKA
574118
India 
Phone  08295616136  
Fax    
Email  dr.sandeepsharma33@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR VEERAKUMARA K 
Designation  PROFESSOR  
Affiliation  SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE 
Address  DEPARTMENT OF KAYACHIKITSA, SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE, LAXMINAGAR, KUTHAPADY, UDUPI, KARNATAKA, INDIA 574118

Udupi
KARNATAKA
574118
India 
Phone  9743490753  
Fax    
Email  khadiravana@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR VEERAKUMARA K 
Designation  PROFESSOR  
Affiliation  SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE 
Address  DEPARTMENT OF KAYACHIKITSA, SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE, LAXMINAGAR, KUTHAPADY, UDUPI, KARNATAKA, INDIA 574118


KARNATAKA
574118
India 
Phone  9743490753  
Fax    
Email  khadiravana@gmail.com  
 
Source of Monetary or Material Support  
SDM AYURVEDA COLLEGE HOSPITAL AND RESEARCH CENTRE LAXMINAGAR KUTHAPADY UDUPI KARNATAKA INDIA 574118 
 
Primary Sponsor  
Name  SDM AYURVEDA COLLEGE HOSPITAL AND RESEARCH CENTRE 
Address  DEPARTMENT OF KAYACHIKITSA SDM AYURVEDA COLLEGE HOSPITAL AND RESEARCH CENTRE LAXMINAGAR KUTHAPADY UDUPI KARNATAKA INDIA 574118 
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 SANDEEP  SDM AYURVEDA COLLEGE HOSPITAL AND RESEARCH CENTRE  SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE, LAXMINAGAR, KUTHAPADY, UDUPI, KARNATAKA, INDIA 574118
Udupi
KARNATAKA 
8295616136

dr.sandeepsharma33@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE SDM COLLEGE OF AYURVEDA UDUPI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: DURVADITAILA LEPA, Reference: CAKRADATTA, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 30(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: VISHATAILA LEPA, Reference: VAIDYA CHINTAMANI, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 30(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  patient full filling the following criteria of Dadru kustha
presence of Udgata mandala with or without other features
1 Central Clearing and peripheral spreading
2 Kandu
3 Raaga
4 Pidaka
5 Daha
6 Rookshata
7 Udgata mandala
8 KOH positive skin scrapings obtained from most seriously affected lesion
 
 
ExclusionCriteria 
Details  1 Subjects having any uncontrolled systemic illness which can interfere with the course
of disease and treatment
2 Other overlapping dermatological diseases will be excluded
3 Subjects under Anti-Fungal drugs will be excluded 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
A Number of Mandala
B Size of Mandala
C Raaga
D Number of Pidaka  
AT 0,14,28 DAY 
 
Secondary Outcome  
Outcome  TimePoints 
A Kandu
B Daha
C Rookshata 
14 and 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 2/ Phase 3 
Date of First Enrollment (India)   23/07/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
A COMPREHENSIVE CONCEPTUAL STUDY ON DADRU KUSHTA-WJPR 14/10/2024 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
THIS IS A OPEN LABLE RANDOMISED CONTROLLED INTERVENTIONAL STUDY THAT WILL CHECK THE EFFICTIVENESS OF VISHATAILA LEPA IN TREATING DADRU KUSTHA ALSO COMPARE IT TO STANDARD DURVADITAILA LEPA AND CHECK IT ON 14 AND 28 DAYS WITH PRIMARY OUTCOMES AS DECREASE IN No. of Mandala (Circular lesions) , Size of Mandala,  Raaga , No. of Pidaka (lesion), WHERE AS SECONDARY OUTCOMES AS DECREASE IN Kandu , Daha, Rookshata.
 
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