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CTRI Number  CTRI/2024/12/078515 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 12/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to assess the effect of Leech therapy in patients of venous ulcer 
Scientific Title of Study   A Single arm clinical study to evaluate the wound healing efficacy of Jalaukavacarana in the managemnet of venous ulcer (Dusta Vrana)  
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 Vishal Malviya 
Designation  PG Scholar 
Affiliation  J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital 
Address  Department of Panchakarma J S Ayurveda Mahavidyalaya, college road, Nadiad-387001 Kheda GUJARAT

Kheda
GUJARAT
387001
India 
Phone  9755605068  
Fax    
Email  malviyavishalraj0407@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Kalapi B Patel 
Designation  Professor and HOD Department of Panchkarma 
Affiliation  J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital 
Address  Department of Panchakarma J S Ayurveda Mahavidyalaya, college road, Nadiad-387001 Kheda GUJARAT

Kheda
GUJARAT
387001
India 
Phone  9428661664  
Fax    
Email  drkalapi@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Kalapi B Patel 
Designation  Professor and HOD Department of Panchkarma 
Affiliation  J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital 
Address  Department of Panchakarma J S Ayurveda Mahavidyalaya, college road, Nadiad-387001 Kheda GUJARAT


GUJARAT
387001
India 
Phone  9428661664  
Fax    
Email  drkalapi@rediffmail.com  
 
Source of Monetary or Material Support  
Sunder Ayurveda teaching pharmacy of J.S. Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital, Nadiad GUJARAT 387001 
 
Primary Sponsor  
Name  J S Ayurveda Mahavidyalaya 
Address  Department of Panchakarma J S Ayurveda Mahavidyalaya, college road, Nadiad-387001 Kheda GUJARAT 
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 Vishalraj Malviya  J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital  Department of Panchakarma J S Ayurveda Mahavidyalaya, college road, Nadiad-387001 Kheda GUJARAT
Kheda
GUJARAT 		 9755605068

malviyavishalraj0407@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, MAM University Nadiad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I868||Varicose veins of other specifiedsites. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-jalaukAvacaraNam, जलौकावचरणम् (Procedure Reference: Susruta Samhita. Dr Ambikadutt Shastri, Chikitsasthana 1st Chapter dvivranachikitsit adhyaya sloka 27-29., Procedure details: The treatment will be done in total 6 sittings of Jalaukāvacāraṇa along with oral medicine and dressing of the ulcer. Jalaukāvacāraṇa will be done on every 7th day. Dressing of the venous ulcer will be done every day with Jātyādi oil in between each two sittings of Jalaukāvacāraṇa. )
(1) Medicine Name: Manjishthadi Kvath, Reference: Sharangadhara samhita By Dr.Brahmanand Tripathi, Sharangadhara. Varanasi: Chaukhambha Surbharati Prakashana; 2017.Sharangadhara Samhita Madhyam Khanda, Kvathadi Kalpana 2/136-142, p. 102, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 10(g), Frequency: bd, Duration: 10 Weeks
(2) Medicine Name: Kaishora Guggulu, Reference: Shrangadhara samhita By Dr. Brahmanand Tripathi, Sharangadhara. Varanasi: Chaukhambha Surbharati Prakashana; 2017.Sharangadhara Samhita Madhyam Khanda, Vataka Kalpana; 7/70- 81, p. 136, Route: Oral, Dosage Form: Guggulu, Dose: 900(mg), Frequency: tds, Duration: 10 Weeks
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient of age between 18 to 60 years and of both the genders.
2. Active venous ulcers.
3. History of recurrence of venous ulcers.
4. Duration of ulcer up to 3 years.
5. Patient having Hb percentage greater than 10 gm/dl
6. Patients with controlled hypertension and diabetes.
7. Patients who fulfill any three symptoms of the above mentioned diagnostic criteria.

 
 
ExclusionCriteria 
Details  1. Pregnant or lactating women.
2. Uncontrolled Hypertension and diabetes.
3. Duration of ulcer more than 3 years.
4. Known case of diseases like STDs, TB, heart diseases and other disorders which lead to fatal condition for the patients.
5. Patients having embolism, bleeding disorder, and other infective skin disorders.
6. Patients with immune-compromised diseases like HIV, HbsAg, and HCV etc.
7. Patient having Hemoglobin percentage lower than 10 gm/dl
8. Other types of wounds such as Malignant wound, tuberculous wound, leprosy ulcer, and syphilitic ulcers.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To check the efficacy of Jalaukavacharana in the patient of venous ulcer by below given points:
1. Vedanā (pain)
2. Gandha (Odour of discharge)
3. Varṇa – (Skin Colour Surrounding Wound)
4. Kaṇḍu (Itching)
5. Venous Clinical Severity Score (VCSS)
6. Wound Measurement
7. Others
 		 8 Weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the changes in Venous clinical severity score (VCSS)  8 Weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   08/01/2025 
Date of Study Completion (India) 01/06/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

This part gives an overall review of this research work undertaken and includes the conclusions derived from the study. The bibliography and the research proforma are lastly appended. 



 
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