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CTRI Number  CTRI/2024/07/071452 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect Of leech Therapy And Swarjikadi Ghrita And Patolyadi Kashaya In Varicose Ulcer 
Scientific Title of Study   A Clinical Study To Evaluate The Efficacy Of Jalaukaavacharana And Swarjikadi Ghrita Along With Patolyadi Kashaya In Management Of Dushta Vrana wsr To Varicose Ulcer  
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Simran Ahuja 
Designation  Pg Scholar 
Affiliation  Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 
Address  PG SCHOLAR Shalya Tantra Department Madan Mohan Malaviya Government Ayurved College Ambamata Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  7014247013  
Fax    
Email  simiahujaa0203@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Mahesh Dixit 
Designation  Professor Shalyatantra Department 
Affiliation  Madan Mohan Malaviya Government Ayurveda College Ambamata Udaipur Rajasthan. 
Address  Shalyatantra Department Madan Mohan Malaviya Government Ayurveda College Ambamata Udaipur Rajasthan.

Udaipur
RAJASTHAN
313001
India 
Phone  9414245459  
Fax    
Email  prof.maheshdixit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Simran Ahuja 
Designation  Pg Scholar 
Affiliation  Madan Mohan Malaviya Government Ayurveda College Ambamata Udaipur Rajasthan. 
Address  Shalyatantra Department Madan Mohan Malaviya Government Ayurveda College Ambamata Udaipur Rajasthan.


RAJASTHAN
313001
India 
Phone  7014247013  
Fax    
Email  simiahujaa0203@gmail.com  
 
Source of Monetary or Material Support  
Madan Mohan Malaviya Government Ayurveda College Ambamata Udaipur Rajasthan. 313001 
 
Primary Sponsor  
Name  Madan Mohan Malaviya Government Ayurveda College Ambamata Udaipur Rajasthan. 
Address  Madan Mohan Malaviya Government Ayurveda College Ambamata Udaipur Rajasthan. 313001 
Type of Sponsor  Government 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 Simran Ahuja  Madan Mohan Malaviya Government Ayurveda College Ambamata Udaipur Rajasthan.  Opd No 1 Shalyatantra Department Madan Mohan Malaviya Government Ayurveda College Ambamata Udaipur Rajasthan.313001
Udaipur
RAJASTHAN 		 7014247013

simiahujaa0203@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Mmm Government Ayurveda College Ambamata Udaipur Rajasthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-jalaukAvacaraNam, जलौकावचरणम् (Procedure Reference: Yogratnakar, Procedure details: Jalaukavacharana Up To 6 Weeks Duration 6 Sitting At 7 Days interval Along with Locally Application Of Swarjikadi Ghrita And Patolyadi Kashaya For Wound Prakshalna And Ropana)
(1) Medicine Name: Swarjikadi Ghrita, Reference: Yogratnakar, Route: Topical, Dosage Form: Ghrita, Dose: 5(g), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-lepa, लेप (Procedure Reference: YOG RATNAKAR, Procedure details: LOCAL APPLICATION OF SWARJIKADI GHRITA AFTER PRAKSHALANA WITH PATOLYADI KASHAYA)
(1) Medicine Name: SWARJIKADI GHRITA, Reference: YOG RATNAKAR, Route: Topical, Dosage Form: Ghrita, Dose: 5(g), Frequency: od, Duration: 6 Weeks
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients having classical signs and symptoms of varicose ulcers.
Age between 25-65 years either sex religion or occupation.
Unilateral varicose vein.
Ulcer area is between 0.1cm²-10 cm²
Hb% above 10gm%
Duration of disease being less than 1 year.
Those ready to give written consent. 
 
ExclusionCriteria 
Details  Varicose ulcer with complications like excessive bleeding, DVT etc.
Jalaukaavacharna ayogya patients as per classics.
Patients having life style disorders like HTN, DM, Dyslipidemia.
Patients having conditions of malignancy and tuberculosis
Varicosities in sites other than lower extremities.
Patient having HIV and STD will be excluded
Bilateral Varicose Ulcer. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assesment of Pain
Assesment of Area Of wound
Assesment of Itching
Assesment of Swelling
Assesment of colour
Assesment of Appearance Of Wound bed
Assesment of Discharge
Assesment of Odour 		 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Assesment of Area Of wound
Assesment of Appearance Of Wound bed
 		 4 week 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 
Date of First Enrollment (India)   31/10/2024 
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="0"
Months="6"
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   This is a multiple arm, parallel group study.In this study group A 20 patients will be administered Jalaukavacharana Up To 6 Weeks Duration 6 Sitting At 7 Days Interval Along With Locally Application Of Swarjikadi Ghrita And Patolyadi Kashaya For Wound Prakshalna And Ropana  and the group B 20patients will be administered Patolyadi Kashaya And Swarjikadi Ghrita For Local Application Daily Up To 6 Weeks.  
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