FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/101506 [Registered on: 19/01/2026] Trial Registered Prospectively
Last Modified On: 16/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Siravedha with Dadrughna lepa in Dadru kushtha (Tinea corporis). 
Scientific Title of Study   A randomised open-label controlled clinical trial to study the add-on effect of Siravedha with Dadrughna 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  Dr Rushikesh Jaysing Gund 
Designation  Post Graduate Student  
Affiliation  SMBT Ayurved College and Hospital  
Address  Department of Panchkarma SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik MAHARASHTRA 422403 India

Nashik
MAHARASHTRA
422403
India 
Phone  9579996009  
Fax    
Email  rushikeshjaysinggund@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pramod Sakharam Mandalkar  
Designation  Proffesor 
Affiliation  SMBT Ayurved College and Hospital  
Address  Department of Panchkarma SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik MAHARASHTRA 422403 India

Nashik
MAHARASHTRA
422403
India 
Phone  9604633832  
Fax    
Email  vdpramod31@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Rushikesh Jaysing Gund 
Designation  Post Graduate Student  
Affiliation  SMBT Ayurved College and Hospital  
Address  Department of Panchkarma SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik MAHARASHTRA 422403 India

Nashik
MAHARASHTRA
422403
India 
Phone  9579996009  
Fax    
Email  rushikeshjaysinggund@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Rushikesh Jaysing Gund 
Address  Department of Panchkarma SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik MAHARASHTRA 422403 India  
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 Rushikesh Jaysing Gund  SMBT Ayurved College and Hospital   OPD No 19 Department of Panchkarma SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik MAHARASHTRA 422403 India
Nashik
MAHARASHTRA 		 9579996009

rushikeshjaysinggund@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMBT Ayurved College and Hospital   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-sirAvedhaH, सिरावेधः and lepa (Procedure Reference: Sushruta Samhita Sutra Sthana chapter number 14 shlokh number 13 and Sharangdhar Samihta Uttarkhand chapter number 11 shlokh number 56 , Procedure details: 9. The patient is seated comfortably with the arm extended, & a tourniquet is applied about four angulas above the cubital fossa to make the median cubital vein prominent the patient is asked to clench the fist, the area is cleaned with antiseptic, & the vein is gently tapped & punctured using a sterile surgical blade, allowing approximately 30 to 60 ml of blood to flow or until signs of adequate bloodletting appear, with gentle tapping or kneading to maintain flow if needed. Bleeding is then allowed to stop spontaneously, hemostasis is achieved with sterile gauze & mild pressure, & a pressure dressing is applied. The patient is monitored for adverse effects such as dizziness or hypotension & advised rest, a light diet, & avoidance of strenuous activity for the day. The procedure may be repeated once weekly for two sittings. The Dadrughna Lepa is applied as a 1 cm thick, adequately thick paste over the affected area, in a direction opposite to hair growth twice a day for 15 days.)
2Comparator ArmProcedure-lepa, लेप (Procedure Reference: 8. Sharangdhar Samihta Uttarkhand chapter number 11 shlokh number 56 , Procedure details: 11. The Dadrughna Lepa is applied as a 1 cm thick, adequately thick paste over the affected area, in a direction opposite to hair growth twice a day for 15 days.)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having signs and symptoms of Dadru Kushtha (i.e., itching,
circular lesions, burning sensation, vesicles) will be selected irrespective
of gender.
Individuals aged between 18 and 60 years
Patients assessed as fit for Siravedha 
 
ExclusionCriteria 
Details  Siravedh should be avoided in the following conditions:
• Severe anemia or hemoglobin deficiency
• Uncontrolled diabetes mellitus
• Pregnancy or active menstrual bleeding
• Immunocompromised patients
• Open wounds or generalized infections
• Patients currently on anticoagulant medications
• Individuals with bleeding disorders such as haemophilia  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in signs and symptoms of Dadru kushtha   15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Where the trial group stands in comparison with control group   18 months 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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 
Date of First Enrollment (India)   27/01/2026 
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 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   This study titled “A Randomised Open-Label Controlled Clinical Trial to Study the Add-on Effect of Siravedha with Dadrughna Lepa in the Management of Dadru Kushtha (Tinea Corporis)” aims to evaluate the effectiveness of Siravedha as an adjunct to Dadrughna Lepa in patients with Dadru Kushtha, a condition described in Ayurveda that closely resembles Tinea corporis and is characterized by itching, erythema, vesicles, and raised circular lesions due to Pitta–Kapha and Rakta vitiation. Tinea corporis affects approximately 7.86% of the Indian population and 20–25% globally, and its chronicity, recurrence, and widespread steroid misuse have resulted in increased treatment failure and poor quality of life. Although Dadrughna Lepa has shown 60–84% symptom improvement, robust randomized controlled trial evidence for its combination with Siravedha is lacking. The study is designed as a randomized open-label controlled clinical trial with a sample size of 66 patients aged 18–60 years, divided equally into two groups. Group A receives Siravedha on Day 1 and Day 8 along with Dadrughna Lepa applied twice daily for 15 days, while Group B receives only Dadrughna Lepa twice daily. Patients are followed up on Day 21, and computer-generated randomization is employed. Subjective parameters such as itching, erythema, vesicles, dryness, and burning sensation, along with objective measures including number and size of lesions, are assessed using a 0–3 grading scale. Investigations include CBC, BT-CT, and HHH. Statistical analysis is performed using the Wilcoxon signed-rank test and Student’s t-test. The study hypothesizes that Siravedha with Dadrughna Lepa will provide superior clinical improvement compared to Dadrughna Lepa alone. This trial is expected to generate scientific evidence supporting the synergistic role of Siravedha with Dadrughna Lepa in managing chronic and recurrent Dadru Kushtha, offering a validated Ayurvedic therapeutic alternative. 
Close