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CTRI Number  CTRI/2025/08/092414 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Trial to study the Effect of Kankshi jala prakshalana in the patients with Dushtavrana. 
Scientific Title of Study   An Open Label Single Arm Clinical Study to Evaluate the effect of Kankshi Jala Prakshalana in Dushtavrana  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrShrikanth Karjagi 
Designation  PG Scholar 
Affiliation  Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka 
Address  Shalyatantra Department, OPD no. 11, Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka
Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka
Tumkur
KARNATAKA
572105
India 
Phone  8660703292  
Fax    
Email  shrikanthkarjagi7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrDharmapal S L  
Designation  HOD and Professor 
Affiliation  Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka 
Address  Shalyatantra Department, OPD no.11, Ashwini Ayurvedic medical College and Research centre, Marluru ring road, Tumkur -572105

Tumkur
KARNATAKA
572105
India 
Phone  9916121607  
Fax    
Email  drdharmapal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shrikant karjagi  
Designation  PG Scholar  
Affiliation  Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka 
Address  Shalyatantra Department,OPD no.11, Ashwini Ayurvedic Medical College and Research centre, Marluru Ring Road-572105

Tumkur
KARNATAKA
572105
India 
Phone  9916121607  
Fax    
Email  shrikanthkarjagi7@gmail.com  
 
Source of Monetary or Material Support  
Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka 
 
Primary Sponsor  
Name  Dr.Shrikanth Karjagi 
Address  Shalyatantra Departement, OPD no.11,Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
DrDharmapal S L  Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrShrikanth Karjagi  Ashwini Ayurvedic Medical College and Research centre   Shalyatantra Department, OPD no.11,FGW-28-32, MGW-28-32,Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka
Tumkur
KARNATAKA 
8660703292

shrikanthkarjagi7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ashwini Ayurvedic Medical College institutional Ethical Comittee  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: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-_prakShAlana-karma, प्रक्षालन-कर्म (Procedure Reference: Sushruta Samhita, Astanga Hridaya, Procedure details: A) POORVA KARMA Informed consent, Sangraha of Sambharadravya, Preparation of Kankshijala, Preparation of Nimbapatra kalka for Lepa, Preparation of patient-Ashvasana, explaining the procedure, positioning; Vrana exposed properly. B) PRADHANA KARMA Vrana Prakshalana with Kankshijala followed by Nimbapatra Lepa application. C) PASHCAT KARMA Sterile bandaging will be done. ) )
(1) Medicine Name: Kankshi, Reference: Rasatarangini, Rasa ratna Samuchhaya, Ayurveda Prakash, Route: Topical, Dosage Form: Churna/ Powder, Dose: 1.25(g), Frequency: od, Duration: 10 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects with ulcers presenting with Lakshanas of Dustavrana.
Subjects of Madhyama Vaya 26 that is aged between 16 years to 70 years.
Subjects will be selected irrespective of Gender, Religion, Occupation and Socio Economic Status.
 
 
ExclusionCriteria 
Details  Subjects suffering from complicated systemic disorders that which interfere in the line of treatment.
Subjects of known cases like Malignancy, Gangrene, Leprosy, TB wound.
Subjects with known cases of HIV, Hepatitis-B.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reductiion in foul smell, Discharge
 
10 days
 
 
Secondary Outcome  
Outcome  TimePoints 
Healing of Dustavrana  10 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/08/2025 
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="2"
Days="4" 
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 Susruta has emphasised Dushtavrana while presenting the definition of Shalyatantra. Vrana Gaatra Vichurnane Vranayateeti Vrana|”  Vrana denotes wound, Gaatra denotes body tissue or part of the body, and Vichurnane denotes breakdown / discontinuity / destruction / rupture. The prevalence of the disease in an Indian epidemiological study states that, the chronic ulcer has the prevalence rate of 4.5/1000 population.

 

Taking the Lakshana into consideration Vrana can be classified into Shuddhavrana and Dustavrana. Doshas and Dushyas that have accumulated excessively and been vitiated transform Shuddhavrana into Dustavrana.The Dustavrana has the clinical features like excessive discharge, foul smell, pain, itching, delayed wound healing etc. A healthy wound in a healthy body heals more quickly and leaves fewer scars than a wound that has been contaminated. There are 4 phases of wound healing, however prolonged cessation or slowdown of healing in any one of these phases cause the wound to become chronic, which can be correlated with Dustavrana that is delayed healing of the Vrana due to vitiated DoshaKankshi is one of the Uparasa which is used for Shodhana and Ropana of the Vrana as per Rasatarangini Rasaratnasamucchaya, and Ayurveda Prakasha. Nimba is known for its Krimighna and also Vranagna propertyAcharya Susruta has specified Shasti Upakrama for Dustavrana, including Alepa, Kashaya, Varti, kalka, Taila, Rasakriya etc. Among which Alepa  is the 2nd upakrama. Acharya Vargbhata, has mentioned Prakshalana, Alepa, Ghrita, Taila, Rasakriya, Churna, and Varti as the Dustavrana Saptavidha Chikitsa, of which the first and second    upakramas are Prakshalana and Alepa. Among various procedures explained Prakshalana and Lepa are economical, easy for the preparation, application and can be performed in outpatient department. The non-healing ulcer generally generates unpleasant symptoms which includes intense pain, exudates, and malodour that can also disrupt day-to-day causing social stigma. Thus, it is necessary to find a solution to overcome these factors. Hence this is an attempt to methodically evaluate the impact of Prakshalana by Kankshijala followed      by Nimbapatra lepa in Dustavrana.

 
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