FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/086266 [Registered on: 05/05/2025] Trial Registered Prospectively
Last Modified On: 02/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study of external application of Shrungaveradi Lepa and Edgajadi Lepa in 72 patients of Dadru Kushtha a skin disease known as tinea corporis 
Scientific Title of Study   An Open Randomised Comparative Clinical Study of Shrungaveradi Lepa and Edgajadi Lepa in the Management of Dadru Kushtha with Special Reference to 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  Umesh Ganeshrao Ghuge 
Designation  PG Scholar 
Affiliation  APMS Ayurved Mahavidyalaya, Sion 
Address  Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, near Sion railway station, Sion East, Mumbai 22
Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, near Sion railway station, Sion East, Mumbai 22
Mumbai
MAHARASHTRA
400022
India 
Phone  9881094175  
Fax    
Email  umeshghuge2208@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Umesh Ganeshrao Ghuge 
Designation  PG Scholar 
Affiliation  APMS Ayurved Mahavidyalaya, Sion 
Address  Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, near Sion railway station, Sion East, Mumbai 22
Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, near Sion railway station, Sion East, Mumbai 22
Mumbai
MAHARASHTRA
400022
India 
Phone  9881094175  
Fax    
Email  umeshghuge2208@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Hemant Shridhar Paradkar 
Designation  Associate Professor 
Affiliation  APMS Ayurved Mahavidyalay, Sion 
Address  Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, near Sion railway station, Sion East, Mumbai 22

Mumbai
MAHARASHTRA
400022
India 
Phone  9987519315  
Fax    
Email  hemant.paradkar@gmail.com  
 
Source of Monetary or Material Support  
APMs Ayurved Mahavidyalaya and Seth R V Ayurvedic Hospital 
 
Primary Sponsor  
Name  Seth RV Ayurved Hospital 
Address  Near Sion Railway Station, Sion East, Mumbai 400022 
Type of Sponsor  Other [Charitable Ayurvedic 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 Umesh Ganeshrao Ghuge  Seth RV Ayurvedic Hospital  Deparetment of Kayachikitsa 4th Floor AMPS Ayurved Mahavidyalaya, Near Sion Railway Station, Sion East, Mumbai 22
Mumbai
MAHARASHTRA 
9881094175

umeshghuge2208@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
APMS Ayurved Mahavidyalaya, Sion  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: Sharangdhar Samhita-Uttarkhand /11/71-76,, Procedure details: Dry Sukshmachurna is prepared by taking equal quantities of Sunthi, Vidanga, Kushtha, & Tagar, and mixing them thoroughly. After the herbs are combined, Gomutra (cow urine) is added to the Churna mixture and Applied on skin.)
(1) Medicine Name: Shrungaveradi Lepa, Reference: Gadnighrah 36/159, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Duration: 21 Days
2Comparator ArmProcedure-lepa, लेप (Procedure Reference: Sharangdhar Samhita-Uttarkhand /11/71-76, Procedure details: Dry Sukshmachurna of Chakramarda, Kustha, Sendhav, Sarshap, Vidang will be taken in equal quantity, mixed thoroughly & macerated with Sauveerkam twice And applied on skin.)
(1) Medicine Name: Edgajadi lepa, Reference: Charak Chikitsasthan 7/126, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Duration: 21 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18 to 60 years

Sex All genders

Patient with signs and symptoms of Dadru Kushtha Tinea corporis like Kandu Raga Pidaka and udgat mandala

Patient understanding and willing to sign the informed consent form

Area of largest lesion 25cm square.
 
 
ExclusionCriteria 
Details  Patient having skin lesions other than Dadru kushtha Tinea corporis like Eczema psoriasis and urticaria

Pregnancy and lactating mother

Known case of AIDS
HIV Positive and Hepatitis B
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Kandu – Itching
Raga - Erythema
Pidaka – papule
Daha - burning
Size and Number of Lesions in specific areas of the body.

 
Three weeks

 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   03/06/2025 
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="6"
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 - NO
Brief Summary  

The primary purpose of this open randomized comparative clinical study is to evaluate and compare the efficacy of Shrungaveradi Lepa and Edgajadi Lepa in the management of Dadru Kushtha - Tinea Corporis, a superficial fungal infection of the skin characterized by itching- kandu, redness -raga, eruptions - pidaka, and raised patches -udgat mandala. According to Ayurveda, Dadru is classified under Kushtha and is associated with Kapha and Pitta dosha imbalances, affecting the skin, blood, muscle, and lymph tissues. In contemporary understanding, Tinea Corporis is a dermatophyte infection commonly affecting adults, especially those exposed to warm, moist conditions. The study involves a total of 72 patients, divided equally into two groups 36 each, with a treatment duration of 21 days. Each formulation is applied locally at a dose of 200 mg per square cm twice daily. The primary hypothesis states that both Shrungaveradi Lepa and Edgajadi Lepa are equally effective, however secondary hypotheses explore whether one may be superior. The study aims to scientifically validate the traditional Ayurvedic topical therapy, offering a potential evidence-based alternative for managing superficial fungal infections.


 
Close