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CTRI Number  CTRI/2025/03/082903 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Lepa Chikitsa Topical Application]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of Non Healing Ulcer with Medicated Topical Application. 
Scientific Title of Study   A Randomized Comparative Clinical Study to Evaluate the Shodhana effect of Tilaabhayadhi Lepa and Nimbadi Kalka Lepa in the management of Dushta Vrana with special reference to Non healing ulcer 
Trial Acronym  TNLNU 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K H M Bharathesh 
Designation  Post Graduate  
Affiliation  BVVS Ayurved Medical College and Hospital Bagalkot  
Address  Department of PG Studies in Shalya Tantra BVVS Ayurved Medical College and Hospital Bagalkot
BVVS Ayurved Medical College and Hospital Bagalkot
Bagalkot
KARNATAKA
587101
India 
Phone  8970582664  
Fax    
Email  khmbthejas@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yogesh S Kulkarni 
Designation  Professor and HOD 
Affiliation  BVVS Ayurved Medical College and Hospital Bagalkot  
Address  Department of PG Studies in Shalya Tantra BVVS Ayurved Medical College and Hospital Bagalkot
BVVS Ayurved Medical College and Hospital Bagalkot
Bagalkot
KARNATAKA
587101
India 
Phone  9886664541  
Fax    
Email  dryogesh6@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mallikarjun S Hiremath 
Designation  Professor and Incharge Principal 
Affiliation  BVVS Ayurved Medical College and Hospital Bagalkot  
Address  Department of Rachana Shareera BVVS Ayurved Medical College and Hospital Bagalkot
BVVS Ayurved Medical College and Hospital Bagalkot
Bagalkot
KARNATAKA
587101
India 
Phone  9482631399  
Fax    
Email  malikdost4u@gmail.com  
 
Source of Monetary or Material Support  
BVVS Ayurved Medical College and Hospital Bagalkot 587101 
 
Primary Sponsor  
Name  Dr K H M Bharathesh 
Address  BVVS Ayurved Medical College and Hospital Bagalkot 287101 
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 K H M Bharathesh  BVVS Ayurved Medical College and Hospital Bagalkot 587101  Shalya Tantra OPD Room No.03 BVVS Ayurved Medical College and Hospital Bagalkot
Bagalkot
KARNATAKA 
8970582664

khmbthejas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BVVS Ayurved Medical College and Hospital Bagalkot Karnataka  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L984||Non-pressure chronic ulcer of skin, not elsewhere classified. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: Sushruta samhita, Procedure details: The prepared Kalka will be applied on the affected part uniformly according to the size of Dusta Vrana.)
(1) Medicine Name: Tilaabhayadi Lepa, Reference: Chakradatta , Route: Topical, Dosage Form: Kalka/ Paste, Dose: 00(NA), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-lepa, लेप (Procedure Reference: Sushruta samhita , Procedure details: The prepared Kalka will be applied on the affected part uniformly according to the size of Dusta Vrana)
(1) Medicine Name: Nimbadi kalaka Lepa, Reference: Sushruta Samhita Chikitsasthana, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 00(NA), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients suffering from Dushta vrana in the age group between 18-70 years and irrespective of gender.
Patients of Nonspecific ulcers of Traumatic ulcer, Arterial ulcer, Venous ulcer, Trophic ulcer, Infective ulcer, Diabetic ulcer and other.
 
 
ExclusionCriteria 
Details  Patients of non healing ulcer with Malignant and Gangrenous changes.
Patients with ulcer of Syphilitic ulcer, Tuberculosis ulcer, Marjolin ulcer, Bedsore ulcer and Leprosy.
Patients of uncontrolled diabetes mellitus.
RVD and HBsAg positive patients.
Pregnant and Lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in Pain(Vedana)
Reduction in Odour(Gandha)
Reduction in Itching(Kandu) 
At the duration of 7days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Discharge(Srava)  At the duration of 7days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   31/03/2025 
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  

          Acharya Sushruta defined Vrana as Gatra Vichoornana, which causes destruction and discoloration of body tissue.1 Dushta Vrana Lakshanas are Krishna, Rakta, Peeta, Shukla Varna, Putimamsa, Puyasrava, Atyartavedana, Dushtashonitasrava, Daha, Paka, Raga, Kandu, Shopha and Dheerghakaleena2.  Dushta Vrana can be correlated to non healing ulcer in allied science.

         Ulcer is a break in the continuity of the covering epithelium, either skin or mucous membrane due to molecular death. Non healing ulcers are characterized by pain, discharge, itching, burning sensation and foul smell. Non healing ulcers include nonspecific ulcers like Traumatic ulcer, Arterial ulcer, Venous ulcer, Trophic ulcer, Infective ulcer, Diabetic ulcer and other.3 An ulcer is a major health problem and it affects nearly 6 million population worldwide. In India it is reported as 4.5 per 1000 population, the incidence of chronic ulcers is expected to increase as the population age increase.4

         In modern science ulcer is managed by debridement, ulcer cleaning and dressing. Desloughing is done either mechanically or chemically. Mechanically by debridement. Hydrogen peroxide which releases nascent oxygen is used as chemical agent. Ulcer cleaning and dressing is done daily or twice daily or once in 2-3 days depending on the type of ulcer and type of dressing used.3

         Acharya Sushruta has told various Shodana measures like Sharirika Shodana by Vamana, Virechana and Sthanika Shodana by Kashaya, Kalka, and Avachurana, etc. Lepa karma is one among Shashtiupakrama in which drugs of herbal, herbo-mineral or animal origin are used for Vrana Lepana. Lepa karma is an integral part of Shashtiupakrama which ensures the protection against the microbes and it act as Vranashodana by reducing Vedana and Srava.5

          Acharya Chakradatta in the context of Bhagandara Chikitsa explained Tilaabhayadi lepa for Bhagandara and Dushtavrana. It contains drugs like Tila, Abhaya, Lodra, Nimba, Haridra, Daruharidra, Vacha, Kusta, Gruhadooma which possess Shodhana properties.6 Acharya Sushruta has mentioned about Nimbadi kalka lepa under Dvivruniya Chikitsa for the Vrana Shodhana which contains drugs like Nimba, Tila and Madhu.7

               Here an attempt is made to evaluate and compare the Shodhana effect of Tilaabhayadi Lepa and Nimbadi kalka Lepa in Dushtavrana with special reference to Non healing ulcer.


 
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