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CTRI Number  CTRI/2025/08/092773 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing the effectiveness of dadruhar ointment and clotrimazole in the treatment of ringworm or fungal infection  
Scientific Title of Study   Evaluation of comparative efficacy of Dadruhar Lepa Guti vs Dadruhar ointment in comparison with 1 percent clotrimazole in the treatment of Dadru Tinea Corporis A three arm RCT 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Garima Meshram 
Designation  PG Scholar  
Affiliation  Mahatma Gandhi Ayurveda College Hospital and research centre  
Address  Department of Agadtantra and Vidhi Vaidyak Mahatma Gandhi Ayurveda College Hospital and Research Centre salod wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8305903877  
Fax    
Email  garimameshram15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Garima Meshram 
Designation  PG Scholar  
Affiliation  Mahatma Gandhi Ayurveda College Hospital and research centre  
Address  Department of Agadtantra and Vidhi Vaidyak Mahatma Gandhi Ayurveda College Hospital and Research Centre salod wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8305903877  
Fax    
Email  garimameshram15@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Minakshi Urkude 
Designation  Associate professor 
Affiliation  Mahatma Gandhi Ayurveda College Hospital and research centre salod hirapur wardha 
Address  Department of Agadtantra and Vidhi Vaidyak Mahatma Gandhi Ayurveda College Hospital and Research Centre salod wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9421727976  
Fax    
Email  minakshi.urkude@dmiher.edu.in  
 
Source of Monetary or Material Support  
Mahatma Gandhi Ayurveda College Hospital and research centre salod hirapur wardha 
 
Primary Sponsor  
Name  Mahatma Gandhi Ayurveda College Hospital and research centre salod hirapur wardha 
Address  Department of Agadtantra and Vidhi Vaidyak Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Maharashtra pincode 442001 
Type of Sponsor  Research institution and hospital 
 
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 Garima Meshram  Mahatma gandhi ayurved college hospital and research centre   Room number 20 Department of Agadtantra and Vidhi Vaidyaka Mahatma Gandhi Ayurved College hospital and research centre salod hirapur wardha Maharashtra pincode 442001
Wardha
MAHARASHTRA 		 83059 03877

garimameshram15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Ayurved College Hospital and Research Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, (2) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: dadruhar ointment, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: dadruhar lepa gutika, Reference: Vangasena samhita, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -
3Comparator Arm (Non Ayurveda)-1% ClotrimazoleType of ointment: Antifungal medication Class: imidazole derivative available in cream, lotion, powder, solution, lozenges It is for external use only. Dose: As per need. Frequency: Twice Daily. Route of Administration: Topical Total Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient willing to give written informed consent
Patients belonging to both the gender
Patients of age group of 18 to 65 years
Diagnosed with Tinea Corporis Dadru
Classical symptoms Kandu Raga Pidika Udgata mandala
 
 
ExclusionCriteria 
Details  Other types of Tinea pedis cruris
Associated skin conditions eczema psoriasis
Any kind of allergy or rash is there

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in Kandu Raga Pidaka and Mandala size and recurrence rate  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
comparison and assessment of efficacy of dadruhar lepa gutika followed by dadruhar ointment and 1 percent clotrimazole in the treatment of dadru tinea corporis   3 week 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 4 
Date of First Enrollment (India)   11/11/2025 
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 Yet Recruiting 
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  

The volunteers will be informed about the study protocol. Willing participants will be randomly selected using a computer generated table. A clinical research format will be prepared and validated. Prior to the study approval will be obtained from the institutional ethics committee and MGACHRC, Salod hirapur wardha and registration will be completed with the clinical trials registry india. After selection each participant will be tested individually and included according to selection criteria. They will be divided into three groups the trial is a randomized  open label three arm comparative study it will be include a 21 day treatment period with follow up on the 7th , 14th and 21th day.

 
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