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CTRI Number  CTRI/2025/05/086984 [Registered on: 15/05/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical study of Karveeradi Lepa in the management of Dadru (Ringworm) 
Scientific Title of Study   Clinical Study of Karveeradi Lepa in Dadru (Ringworm) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sachin Kumar 
Designation  MD SCHOLAR 
Affiliation  Uttaranchal Ayurvedic College 
Address  Department of Agad Tantra, Uttaranchal Ayurvedic College 17, Old Mussoorie Road, Kairwaoan Gaon, Dehradun, Uttarakhand 248009

Dehradun
UTTARANCHAL
248009
India 
Phone  8957977495  
Fax    
Email  drsachin360682@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr P K Gupta 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Uttaranchal Ayurvedic College 
Address  Department of Agad Tantra, Uttaranchal Ayurvedic College 17, Old Mussoorie Road, Kairwaoan Gaon, Dehradun, Uttarakhand 248009

Dehradun
UTTARANCHAL
248009
India 
Phone  9412967100  
Fax    
Email  pkgayurveda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sachin Kumar 
Designation  MD SCHOLAR 
Affiliation  Uttaranchal Ayurvedic College  
Address  Department of Agad Tantra, Uttaranchal Ayurvedic College 17, Old Mussoorie Road, Kairwaoan Gaon, Dehradun, Uttarakhand 248009

Dehradun
UTTARANCHAL
248009
India 
Phone  8957977495  
Fax    
Email  drsachin360682@gmail.com  
 
Source of Monetary or Material Support  
Uttaranchal Ayurvedic College 17, Old Mussoorie Road, Kairwaoan Gaon, Dehradun, Uttarakhand 248009 
 
Primary Sponsor  
Name  Uttaranchal Ayurvedic College 
Address  Department of Agad Tantra, Uttaranchal Ayurvedic College 17, Old Mussoorie Road, Kairwaoan Gaon, Dehradun, Uttarakhand 248009 
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 Sachin Kumar  Uttaranchal Ayurvedic College  Department of Agad Tantra, Uttaranchal Ayurvedic College 17, Old Mussoorie Road, Kairwaoan Gaon, Dehradun, Uttarakhand 248009
Dehradun
UTTARANCHAL 
8957977495

drsachin360682@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RESEARCH DEGREE COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B354||Tinea corporis. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: CHARAK CHIKITSASTHANA 7/94, Procedure details: EXTERNAL APPLICATION CONTINUOUSLY FOR 1 MONTH)
(1) Medicine Name: KARVEERADI LEPA, Reference: CHARAK CHIKITSASTHANA 7/94, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 1 Months
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Age group between 10 years to 50 years
Gender- both
Patients diagnosed as cases of Dadru on the basis of classical symptoms-
a. Kandu (Itching)
b. Pidika (Rashes)
c. Raga (Redness)
d. Rukshata (Dryness)
e. Utsannamandala (Maculopapular Eruptions) 
 
ExclusionCriteria 
Details  Age less than 10 years and more than 50 years
Patients under long standing medication
Pregnant women
Lactating women
Chronicity of more than 5 years
Pre existing in condition 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in Sign and Symptoms of Dadru  Before Treatment, After Treatment, after 1st Follow up of 15 Days, after 2nd Follow up of 15 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Quality of Life of Patients of Dadru  Before Treatment, After Treatment, after 2nd Follow up of 15 Days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/05/2025 
Date of Study Completion (India) 01/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/10/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

MATERIAL AND METHODS:

1.       All the classical texts will be well churned to establish the facts about Karveeradi Lepa and its application on Dadru.

2.       Thesis a Single Blind Clinical Trial.

3.       The main object of the present work is to undertake a clinical study of Karveeradi Lepa in the management of Dadru.

Pharmacognostic study of Single ingredients and its authentication will be Selection of the Cases

For this clinical study, patient of age group 10 year to 50 years will be randomly selected for the study. The cases will be registered on the clinical basis and investigation from OPD and IPD of Agadtantra, Panchakarma and Kayachikitsa department of Uttaranchal done at PG Department of Dravyaguna of Uttaranchal Ayurvedic Medical College and Hospital, Dehradun as per guidelines.

Uttaranchal Ayurvedic Medical College and Hospital, Dehradun, Cases will be selected randomly for this clinical study irrespective of Religion, Occupation, Sex etc.

A detailed proforma will be prepared on the basis of the Ayurvedic text and allied sciences. The patient fulfilling the inclusion and exclusion criteria will be registered on this proforma and scoring of the different features will be done on the assessment criteria.

Inclusion Criteria

1.       Age group->10yearsand<50 years

2.       Sex-Both

3.       Patients diagnosed as having Dadru on the basis of classical symptoms-

a.       Kandu

b.       Pidika

c.       Raga

d.       Rukshata

e.       Utsanmandala

Exclusion Criteria

1.    Age-<10yearsand>50years

2.    Patient under long standing medication

3.    Pregnant Women

4.    Lactating Women

5.    Chronicity more than 5 years

6.    Pre-existingsk in condition

 

Criteria for With-drawl

1.       Any Inter-current Illness

2.       Personal reason

3.       If any side effect occurs.

 

CRITERIA FOR ASSESSMENT

The results of the therapy will be assessed on the basis of clinical signs and symptoms mentioned in Ayurvedic classics. Functional capacity of the patients will also assess and laboratory investigations will be repeated at the end of the treatment.

     Overall effect of the treatment will be assessed on the basis of the criteria given as below:

a.       CompleteRemission-100% relief

b.       MarkedImprovement-75-99% relief

c.       ModerateImprovement->50-74%relief

d.       MildImprovement->25-<49%relief

e.       NoImprovement-<25% relief

 

GROUPING

No Grouping because it is a Single Blind Clinical Trial.

Period– One Month

Dosing–External Application

 

Scoring Criteria

The result of the therapies will be assessed on symptoms of Dadru mentioned in Ayurveda.

 

S.

No.

Symptoms

0

1

2

1.

Kandu(Itching)

No Kandu

Mild (No disturbance while doing work)

Moderate (Disturbs the work)

2.

Raga(Erythema)

Normal Skin

Mild Redness

Moderate Red

 

 

Colour

 

 

3.

Pidika(Eruption)

No pidika

Alpa pidika

Madhyama pidika

4.

Rukshata

(Dryness)

No rukshata

Mild rukshata

Moderate rukshata

5.

Utsannamandala (Elevation of Lesion)

No Mandala

Mild Mandala

Moderate Mandala

Follow-Up:

•       1stFollowup– After15th day of 2nd Sitting

•       2ndFollowUp- After 1 month of 2nd Sitting

 

Method of Data Collection:

After the completion of treatment, the assessment will be done on same criteria as before the treatment and scoring will be done on the same pattern. The different tables of scores, obtained before treatment and after treatment, will be prepared for the comparison and statistical analysis will be done.

 

OBSERVATION:

The observation of the patients will be carried out before and after completion of the treatment.

Statistical Analysis

To obtain the efficacy of the therapy, proper statistical analysis will be carried out of available data.

Wilcoxon Test.

 

Result: The result will be analyzed statistically and discussed.

 


 
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