| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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. |