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CTRI Number  CTRI/2025/09/093984 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 05/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative study of Siddharthak Gel and Siddharthak Lepa in patients suffering from Dadrukushtha (Tinea Corporis) 
Scientific Title of Study   Randomized Controlled Clinical Trial to evaluate the efficacy of Siddharthak Gel over Siddharthak Lepa in the management of Dadrukushtha (Tinea Corporis) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajit Vijaykumar Patil 
Designation  PhD Scholar 
Affiliation  Tilak Ayurved Mahavidyalaya Pune 
Address  PhD Scholar, Department of Ayurved Samhita Siddhant Tilak Ayurved Mahavidyalaya, Pune 583, Rasta Peth, Pune 411011

Pune
MAHARASHTRA
411011
India 
Phone  9860756724  
Fax    
Email  ajitpatil23@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohan Ramchandra Joshi 
Designation  Guide and Professor 
Affiliation  Tilak Ayurved Mahavidyalaya Pune 
Address  Guide and Professor, Department of Ayurved Samhita Siddhant Tilak Ayurved Mahavidyalaya, Pune 583, Rasta Peth, Pune 411011

Pune
MAHARASHTRA
411011
India 
Phone  9822435536  
Fax    
Email  manvantar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ajit Vijaykumar Patil 
Designation  PhD Scholar 
Affiliation  Tilak Ayurved Mahavidyalaya Pune 
Address  PhD Scholar, Department of Ayurved Samhita Siddhant, Tilak Ayurved Mahavidyalaya, Pune 583, Rasta Peth, Pune 411011

Pune
MAHARASHTRA
411011
India 
Phone  9860756724  
Fax    
Email  ajitpatil23@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Ajit Vijaykumar Patil 
Address  583 Rasta Peth Pune 411011 
Type of Sponsor  Other [Self] 
 
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 Ajit Vijaykumar Patil  Seth Tarachand Ramnath Charitable Ayurvedic Hospital, Tilak Ayurved Mahavidyalaya, Pune  Department of Kayachikitsa, Tilak Ayurved Mahavidyalaya Pune.
Pune
MAHARASHTRA 		 9860756724

ajitpatil23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical 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
1Comparator ArmDrugClassical(1) Medicine Name: Siddharthak Lepa, Reference: Charaka Samhita, Chikitsa Sthana 7/91–92 – Siddharthaka Snana, Route: Topical, Dosage Form: Lepa Churna, Dose: 3.5(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 15 Days, Reference: No, Route: -, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
2Intervention ArmDrugClassical(1) Medicine Name: Siddharthak Gel, Reference: Charaka Samhita, Chikitsa Sthana 7/91–92 – Siddharthaka Snana, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3.5(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 15 Days, Reference: No, Route: -, Dosage Form: Malahara/ Ointment/ Balm, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Age: - 20 to 50 years age of group participants irrespective of Gender Religion Socio-economic and Marital Status suffering from dadrukushtha (Tinea
corporis)
2) Participant assessed and diagnosed thoroughly based on Ayurvedic classical signs & symptoms of dadrukushtha
3) Participant having multiple lesions of dadrukushtha on body 
 
ExclusionCriteria 
Details  1) Known participant with history of other systemic disorders like diabetes mellitus HIV Tuberculosis etc
2) Participant’s receiving prolonged immunosuppressant and antibiotic therapy
3) Known participant having history of Chronic and severe cases associated with complications or secondary infection
4) Treated case & those who were received topical antifungal treatment within 1 week before baseline visit
5) Participant Currently receiving anti-fungal treatments like systemic or local
6) Participant suffering from other skin diseases than dadru like psoriasis, herpes etc 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Global Assessment Score (GAS) based on the evaluation of six signs and symptoms of Dadrukushtha (Tinea Corporis):
• Kandu (itching)
• Raga (redness)
• Visarpana (spreading of lesion)
• Tamra Varna (coppery discoloration)
• Pidaka (papular eruptions)
• Mandala (number and size of circular lesions)

Each parameter will be assessed using a 0–3 severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).
The total GAS will be calculated by summing the scores of all parameters (Range: 0–18). 		 • Day 0 (Baseline)
• Day 7 (First Follow-up)
• Day 15 (End of Treatment) 
 
Secondary Outcome  
Outcome  TimePoints 
DLQI (Dermatology Life Quality Index) Score  Day 0, Day 15 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   01/10/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ajitpatil23@gmail.com].

  6. For how long will this data be available start date provided 01-10-2025 and end date provided 01-10-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The present study is a randomized, controlled, open label clinical trial designed to evaluate and compare the efficacy of Siddharthak Gel and Siddharthak Lepa in the management of Dadrukushtha Tinea Corporis. Eighty patients diagnosed with Dadrukushtha aged between 20 and 50 years will be randomly allocated into two groups. The Siddharthak Gel group will receive topical application of a gel based Siddharthak formulation while the Siddharthak Lepa group will receive a traditional Lepa application. Primary outcome measures include the assessment of Kandu itching, Raga redness, Visarpana spreading, Tamra varna coppery discoloration, Pidaka papules, and Mandala lesion characteristics using Global Assessment Scoring GAS. Secondary outcomes include changes in the Dermatology Life Quality Index DLQI and monitoring of adverse events. The study hypothesis is that Siddharthak Gel offers superior or equivalent clinical outcomes with better patient compliance compared to traditional Siddharthak Lepa. 
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