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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | 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.)
| 2 | Comparator Arm (Non Ayurveda) | | - | split thickness skin grafting | Debridement 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. |