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CTRI Number  CTRI/2025/05/086653 [Registered on: 09/05/2025] Trial Registered Prospectively
Last Modified On: 09/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [wound management by ayurvedic medicines]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the wound healing activity of Calotropis gigantea leaf extract and Jatyadi ointment among 110 participants 55 each where Calotropis gigantea is expected to show more efficiency than Jatyadi taila 
Scientific Title of Study   Clinical Evaluation of Wound Healing Activity of Arka Patra Extracted Ointment in Agantuja Vrana - A Randomized Controlled Clinical Trial. 
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 Harishankar P V 
Designation  PhD Scholar 
Affiliation  KAHERS Shri BM Kankanwadi Ayurved Mahavidyalaya 
Address  Department of Shalya Tantra KAHERS Shri BM Kankanwadi Ayurved Mahavidyalaya
Department of Shalya Tantra KAHERS Shri BM Kankanwadi Ayurved Mahavidyalaya Shahapur Belagavi 590003
Belgaum
KARNATAKA
590003
India 
Phone  08592056903  
Fax    
Email  628harishankarpv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Laxmikant S D 
Designation  Professor 
Affiliation  KAHERS Shri BM Kankanwadi Ayurved Mahavidyalaya 
Address  Department of Shalya Tantra KAHERS Shri BM Kankanwadi Ayurved Mahavidyalaya Shahapur Belagavi
Department of Shalya Tantra KAHERS Shri BM Kankanwadi Ayurved Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India 
Phone  8075658247  
Fax    
Email  628harishankarpv@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Laxmikant S D 
Designation  Professor 
Affiliation  KAHERS Shri BM Kankanwadi Ayurved Mahavidyalaya 
Address  Department of Shalya Tantra KAHERS Shri BM Kankanwadi Ayurved Mahavidyalaya Shahapur Belagavi
Department of Shalya Tantra KAHERS Shri BM Kankanwadi Ayurved Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India 
Phone  8075658247  
Fax    
Email  628harishankarpv@gmail.com  
 
Source of Monetary or Material Support  
OPD 8 And IPD of Department of Shalya Tantra KAHERS Shri BM Kankanwadi Ayurved Mahavidyalaya Shahapur Belagavi 590003 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Harishankar P V  KAHERS Shri BMK Ayurved Mahavidyalaya  OPD 8 And IPD Department of Shalya Tantra KAHERS Shri BM Kankanwadi Ayurved Mahavidyalaya Shahapur Belagavi 590003
Belgaum
KARNATAKA 		 08592056903

628harishankarpv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for research on human subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:T14||Injury of unspecified body region. Ayurveda Condition: AGANTUJAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Arka patra extracted oinment, Reference: charaka samhita chikitsa 25/95 , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -total 10 gm oinment per patient used for daily dressing of the wound for 14 days
2Comparator ArmDrugClassical(1) Medicine Name: jatyadi oinment, Reference: sharangadhara samhita madhyama khanda 9/166, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -dressing of agantuja vrana done with jatyadi oinment 10 gm in divided dose for 14 days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with clinical features of Agantuja vrana
Wounds that can be assessed by the size margin surface and granulation tissue formation 
 
ExclusionCriteria 
Details  Patients with known case of uncontrolled Type-II DM TB HbsAg HIV I & II varicose ulcer malignant wounds
Wounds that are intended to heal by primary intention 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Size Margin and Surface Granulation tissue Epithelialization assessed by Bates Jensen Criteria for Wound Assessement  Baseline Seventh day and 14th day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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/ Phase 3 
Date of First Enrollment (India)   01/07/2025 
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="2"
Months="0"
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  


 
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