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CTRI Number  CTRI/2024/04/065263 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 04/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic Management of Non Healing Ulcer  
Scientific Title of Study   An Open Labelled Clinical Study To Evaluate The Effect Of Hamsapadi Kashaya Parisheka In Dushta Vrana WSR To Non Healing Ulcer  
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 Prajapati Parth Rameshbhai  
Designation  Pg Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College Of Ayurveda 
Address  Department of Shalyatantra Sri Dharmasthala Manjunatheshwara College Of Ayurveda Kuthpady Udupi

Udupi
KARNATAKA
574118
India 
Phone  9426907608  
Fax    
Email  parthr120@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prashanth K  
Designation  Associate Professor  
Affiliation  Sri Dharmasthala Manjunatheshwara College Of Ayurveda 
Address  Department of Shalyatantra Sri Dharmasthala Manjunatheshwara College Of Ayurveda Kuthpady Udupi

Udupi
KARNATAKA
574118
India 
Phone  9448857560  
Fax    
Email  drp235@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prashanth K  
Designation  Associate Professor  
Affiliation  Sri Dharmasthala Manjunatheshwara College Of Ayurveda 
Address  Department of Shalyatantra Sri Dharmasthala Manjunatheshwara College Of Ayurveda Kuthpady Udupi

Udupi
KARNATAKA
574118
India 
Phone  9448857560  
Fax    
Email  drp235@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara Ayurveda Pharmacy 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College Of Ayurveda 
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda Kuthpady Udupi-574118  
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 Prajapati Parth Rameshbhai   Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital  Opd no 5 Department of Shalyatantra Kuthpady Udupi 574118
Udupi
KARNATAKA 		 9426907608

parthr120@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC for Human  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 ArmDrugClassical(1) Medicine Name: Kaishora Guggulu , Reference: Sarangadhara Samhita Madhyam Khanda 7 verse 70 to 81 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 750(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Usnodaka), Additional Information: -
(2) Medicine Name: Gandhaka Rasayana , Reference: Rasatarangini 8 verse 81 to 86, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 750(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Usnodaka ), Additional Information: -
2Intervention ArmProcedure-pariSheka, परिषेक (Procedure Reference: Susruta Samhita Chikitsa Shthana Chapter 1 verse no 8, Procedure details: Poorva karma : informed consent, Kashaya preparation of Hamsapadi, ulcer cleaning with normal saline Pradhana karma : parisheka of kashaya should be done for 5 minutes Paschata karma : then application of sterile gauze dipped in hamsapadi kashaya will kepty over ulcer & bandaging will be done )
(1) Medicine Name: Hamsapadi (Adiantum lunulatum), Reference: Kaiyadeva Nighantuh, Aushadh varga, verse no. 766-767, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 200(ml), Frequency: od, Duration: 15 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subject suffering from Vrana for duration of 17 days or more
Ulcer having a size less than 15 cm2
 
 
ExclusionCriteria 
Details  Patients suffering from severe systemic illness like uncontrolled diabetes mellitus, TB, HIV.
Patients suffering from Gangrene, Osteomyelitis, Burns, Sepsis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out the effect of Hamsapadi Kashaya Parisheka in Dusta vrana by observing the changes in VAS for pain and Size of the Ulcer   Observation of the inclusion and exclusion criteria will be nmoted on this days which are
0day
3rd day
7th day
15th day  
 
Secondary Outcome  
Outcome  TimePoints 
Observing changes in VAS scale for pain   15 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   N/A 
Date of First Enrollment (India)   15/04/2024 
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  
Vrana is “Vranagatra vichoornane, vranayathi iti vrana”. Here Vrana is that which causes destruction of the tissue and discoloration of the body parts. Similarly in modern science an ulcer is a break in the continuity of the covering epithelium either skin or mucus membrane. Here Hamsapadi Kashaya Parisheka will be used for Parisheka Procedure in Dusta Vrana. 30 pateints will be selected who fulfill the inclusion criteria for study and patient will be assessed before and after the treatment.
 
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