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CTRI Number  CTRI/2025/04/085653 [Registered on: 25/04/2025] Trial Registered Prospectively
Last Modified On: 25/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study On Skin Graft With And Without Jalaukavacharn And Yashtimadhu Kwatha Prakshalana As Pretreatment In Management Of Ulcer Which Not Healed Since Long Term 
Scientific Title of Study   A Clinical Study On Split Thickness Skin Grafting (Stsg) With And Without Jalaukavacharn And Yashtimadhu Kwath Prakshalan As Pre-treatment In The Management Of Dushta Vrana (Chronic Non Healing Ulcer) An Open Label 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  Mayuriben Kamleshgiri Goswami 
Designation  PG Scholar 
Affiliation  Government Akhandanand Ayurved College and Hospital 
Address  Department of Shalya Tantra OPD No 14 Government Akhandanand Ayurved College and Hospital Ahmedabad Gujarat 380001 India Ahmedabad GUJARAT 380001 India Ahmadabad GUJARAT 380001 India

Ahmadabad
GUJARAT
380001
India 
Phone  7567474801  
Fax    
Email  goswamimayuri99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Harshit S Shah 
Designation  Pricipal and Professor 
Affiliation  Government Akhandanand Ayurved College and Hospital 
Address  Department of Shalya Tantra OPD No 14 Government Akhandanand Ayurved College and Hospital Ahmedabad Gujarat 380001 India Ahmedabad GUJARAT 380001 India Ahmadabad GUJARAT 380001 India

Ahmadabad
GUJARAT
380001
India 
Phone  9824068760  
Fax    
Email  sejharsh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Harshit S Shah 
Designation  Pricipal and Professor 
Affiliation  Government Akhandanand Ayurved College and Hospital 
Address  Department of Shalya Tantra OPD No 14 Government Akhandanand Ayurved College and Hospital Ahmedabad Gujarat 380001 India Ahmedabad GUJARAT 380001 India

Ahmadabad
GUJARAT
380001
India 
Phone  9824068760  
Fax    
Email  sejharsh@gmail.com  
 
Source of Monetary or Material Support  
Government Akhandanand Ayurved College and Hospital Ahemdabad Gujrat 380001 India  
 
Primary Sponsor  
Name  Government Akhandanand Ayurved College and Hospital 
Address  Department of Shalya Tantra OPD No 14 Government Akhandanand Ayurved College and Hospital Ahmedabad Gujarat 380001 India Ahmedabad GUJARAT 380001 India Ahmadabad GUJARAT 380001 India 
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 
Mayuriben Kamleshgiri Goswami  Government Akhandanand Ayurved College and Hospital  Department of Shalya Tantra OPD No 14 Government Akhandanand Ayurved College and Hospital Ahmedabad Gujarat 380001 India
Ahmadabad
GUJARAT 
7567474801

goswamimayuri99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAYURIBEN K. GOSWAMI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-sandhAna-karma, सन्धान-कर्म (Procedure Reference: Susruta sutrasthan adhyay 16 sloka 27 to 31, Procedure details: Jalaukavcharana & Yashtimadhu Kwatha Continuous sittings without any gape will be carried out up to Dusta Vrana convert into Sudhdha Vrana. Procedure of STSG - Split Thickness Skin Graft Surgery after Dusta Vrana convert into Sudhdha Vrana.)
2Comparator Arm (Non Ayurveda)-split thickness skin graftingDebridement under suitable anesthesia will be done. Standard dressing will be carried out up to dusta vrana convert into sudhdha vrana. Then STSG will apply after dusta vrana convert into sudhdha vrana.
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with Sign and symptoms of Dushta vranaxix Chronic Non healing Ulcer

Patients with previously rejected skin grafts
Age greater than is equal to 18 and less than is equal to 60 years

Patients are selected irrespective of caste gender and religion

Patient with single ulcer with size less than 7cm lenth 7cm wide will be include in study

HbA1c level is less than is equal to 7

Patient with blood pressure is less then is equal to 150 systolic 90 diastolic mmHg

Venous ulcer

Diabetic ulcer

Traumatic wound which fail to heal

Infectious ulcer

Pressure sore 
 
ExclusionCriteria 
Details  Patients with infectious diseases like HBsAg AIDS

Patients with any coagulopathy like Haemophilia

Vulnerable group of people like mentally ill
Immunocompromised patients

Pressure sore on sole 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluation of Effect Of Two Therapies on acceptance and Rejection Of Graft  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improve Quality Of Life Of Patient   60 days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 3/ Phase 4 
Date of First Enrollment (India)   19/05/2025 
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  

Every year chronic wounds affect a large number of population and severely reduce their quality of life. Current statistic indicate that nearly 6 million people suffer due to chronic wounds worldwide. There are very small number of Indian studies available on the epidemiology of chronic wounds. According to journal of wound care, the prevalence rate of chronic wounds in the community was reported as 4.5 per 1000 population whereas that of acute wound was nearly doubled at 10.5 per 1000 population. "The causes for chronic wounds are many, including such systemic conditions atherosclerosis, diabetes mellitus, leprosy and tuberculosis. Other major causes include venous ulcers, pressure sores, trauma, and vasculitis.
As described by Acharya Sushruta, Skin grafting is most useful surgical procedure in present era. Splits thickness skin grafting or STSG is one of the types of skin grafting. But skin grafting may be unsuccessful for numerous reasons. The most common cause for skin graft rejection is hematoma beneath the graft. Similarly, seroma formation may prevent graft adherence to the underlying wound bed, preventing the graft from receiving the necessary nourishment, as detailed above. Movement of the graft or shear forces may also lead to graft failure through disruption of the fragile attachment of the graft to the wound bed. Another common source of failure is a poor recipient site. The wound may have poor vascularity, or the surface contamination may have been too great to allow graft rejection. Infection is also most common cause of graft rejection. According to one study, graft loss secondary to infection was recorded in 31 patients . The microbiological cultures revealed Pseudomonas aeruginosa in 58.1 percentage of the cases, followed by Enterobacter, Staphylococcus aurus, Acinetobacter enterococci.*
The leech produces a number of important substances which contribute to the special property of the bite, including an anticoagulant, a local vasodilator and local anesthetic. Like Hirudin, Hyaluronidase, Hementin etc. They secrete anticoagulants to prevent blood clots and relieve pressure due to pooling blood Leech saliva helps to re-establish bloodflow means of a vasodilator. Deprive blood clots and decreased chances of venous the graft in recipient area, it established the connection with recipient bed by 3 stages: Plasmic Imbibition, Inosculation and Neovascularization. After the combined effect of leech saliva, it stasis. Increased fresh and oxygenated blood to the ulcer area increase viable tissue to the ulcer. Decrease infection and dead tissue. After placing facilitates the acceptance of graft. Thus this novel study will beneficial for future plastic and reconstructive surgery.
In the treatment of all types of wounds and inflammations Yashtimadhu is considered as the drug of choice.
In inflammatory conditions of the eye and various types of Vrana, Chakradutta has advocated the use of this drug. Acharya Charaka has advocated the use of this drug in Vataja and Raktaja diseases at various places. In Sushruta Samhita also described its use in pain in various surgical and medical diseases. Yashtimadhu has Madhura Rasa, Sheeta Virya, Madhura Vipaka and is Vata-Pitta Shamaka. Moreover, studies conducted on modern scientific parameters have proved the healing, anti- ulcer, anti-inflammatory and skin regeneration activity of Yashtimadhu. Sodium glycyrrhizate possessed anti ulcer activity and stimulation of regeneration of skin. 
Pre treatment of Jalaukavacharanaa shows significant results in STSG in the the management of dushta varna(Chronic non healing ulcer). Salivary secretion of jalauka deprived blood clots and decreased chances of venous stasis. Increased fresh and oxygenated blood to the ulcer area increase viable tissue to the ulcer, decrease infection and dead tissue, due to proper venous drainage established by jalaukavacharana neovascularisation easily established. Due to proper nutrition supply plasmtic imbibition also take place.
So acceptance of the graft will increase after jalaukavacharan and yastimadhu kwatha prakshalan.
 
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