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CTRI Number  CTRI/2026/02/103392 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 10/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study to evaluate the role of leech therapy in keloid 
Scientific Title of Study   Randomized controlled clinical trial to evaluate the efficacy of Jalaukavacharana in the management of Vranagranti Keloid 
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 Khushboo Rajesh Katariya  
Designation  PG Scholar Shalyatantra Department 
Affiliation  CSMSS Ayurved Mahavidyalaya And Rugnalaya  
Address  CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Department Of Shalyatantra OPD No 16
Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India 
Phone  7350050758  
Fax    
Email  khushbookatariya11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Babasaheb Nana Gadve 
Designation  Professor and HOD Shalyatantra Department 
Affiliation  CSMSS Ayurved Mahavidyalaya And Rugnalaya  
Address  CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Department Of Shalyatantra OPD No 16
Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India 
Phone  9822682898  
Fax    
Email  drgadvekayakalp@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Khushboo Rajesh Katariya  
Designation  PG Scholar Shalyatantra Department 
Affiliation  CSMSS Ayurved Mahavidyalaya And Rugnalaya  
Address  CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Department Of Shalyatantra OPD No 16
Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India 
Phone  7350050758  
Fax    
Email  khushbookatariya11@gmail.com  
 
Source of Monetary or Material Support  
Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Maharashtra India 431011 
 
Primary Sponsor  
Name  CSMSS Ayurved College Kanchanwadi Chhatrapati Sambhajinagar  
Address  CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Maharashtra India 431011 Department Of Shalyatantra OPD No 16 Kanchanwadi Chhatrapati Sambhajinagar 
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 Khushboo Rajesh Katariya  CSMSS Ayurved Mahavidyalaya And Rugnalaya   OPD No 16 Of Shalyatantra Department CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Department Of Shalyatantra OPD No 16 Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA 		 7350050758

khushbookatariya11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC CSMSS Ayurved College And Hospital Kanchanwadi Chhatrapati Sambhajinagare   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:PCS||. Ayurveda Condition: VRANAJAGRANTHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Jalaukavacharana (Leech Therapy) (Procedure Reference: Sushruta Samhita, Sutrasthana, Procedure details: 1. Purva Karma (Pre-Procedure) i. Procedure explained to the patient. ii. Written informed consent obtained. iii. Lesion site cleaned with sterile water. 2. Pradhana Karma (Main Procedure) i. Leech applied to the site; it attaches within minutes. ii. If not, a slight prick is made to encourage bleeding. iii. Leech forms a horseshoe shape at the neck region. iv. Moist cotton placed over the leech; left for up to 45 min. v. If not detached, turmeric is applied near the mouth for removal. 3. Pashchat Karma (Post-Procedure) i. Bite site cleaned; dressed with Haridra churna & sterile bandage. ii. Leech cleaned, turmeric applied to induce vomiting. iii. Gentle strokes from tail to mouth aid blood expulsion. iv. Rinsed, wiped, & placed in a separate recovery container to prevent cross-contamination. v. Follow up every 7 days, 4 settings/month.)
2Comparator Arm (Non Ayurveda)-Intralesional Corticosteroid Injection (Triamcinolone Acetonide)A) Purva Karma: Informed consent taken. The injection site cleaned with alcohol. B) Pradhana Karma: Triamcinolone injected intralesionally at multiple points (1 cm apart) inside the keloid. C) Paschat Karma: Compression is applied post-injection. Advised no washing/touching. Follow-up every 7 days, 4 settings/month.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The patients of age group between 20 to 60 years irrespective of gender
Patients clinically diagnosed with Vranagranti Keloid
 
 
ExclusionCriteria 
Details  Infected inflamed or ulcerated keloids
Allergy to leech saliva or corticosteroids
Bleeding disorders uncontrolled hypertension diabetes or immunocompromised status 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in pain itching and burning sensation assessed using Visual Analogue Scale and change in size colour and hardness of keloid assessed clinically from baseline to end of treatment  28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1 
Date of First Enrollment (India)   26/02/2026 
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
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Keloids are fibroproliferative dermal lesions resulting from abnormal wound healing and excessive collagen deposition. In Ayurveda, a comparable condition is described as Vranagranthi, caused by vitiation of Doshas and Rakta. Conventional treatments for keloids are associated with high recurrence and adverse effects. Jalaukavacharana (leech therapy), a form of Raktamokshana, is indicated in Rakta-Pitta predominant disorders and abnormal wound healing. Hence, this study aims to evaluate the efficacy of Jalaukavacharana in the management of Vranagranthi (keloid).




The study will be conducted on 60 diagnosed patients of Vranagranthi i.e., Keloid.




Screening of patients for inclusion




Initial Assessment for Patient Selection 




Informed written consent 




Randomization and group Allocation 




Trial group (A) 30 Patients- Jalaukavacharana 





Control group (B) 30 Patients- Triamcinolone Acetonide





Follow up for assessment ( For a maximum of 28 days)





Observation & Results will be noted 





Statistical analysis




Discussion and Conclusion

 
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