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CTRI Number  CTRI/2025/03/082379 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 07/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To See effect of Dushtavranaprashaman Lepa in Treatment of Dushta Vrana with reference to Infected Wound 
Scientific Title of Study   RANDOMIZED CONTROLLED OPEN CLINICAL STUDY TO EVALUATE THE EFFICACY OF DUSHTAVRANPRASHAMAN LEPA IN THE MANAGEMENT OF DUSHTA VRANA W.S.R. TO INFECTED WOUND. 
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 Hemant Nanaji Thorat  
Designation  MS Shalyatantra Scholar(Ayurveda) 
Affiliation  Dr.VJD Gramin Ayurved Mahavidyalaya,Patur,Akola 
Address  Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka Mata Mandir, Patur,Tal-Patur,Dist-Akola Pin-444501 MAHARASHTRA INDIA

Akola
MAHARASHTRA
444501
India 
Phone  7021443835  
Fax    
Email  hthorat122@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gayatri Mawale  
Designation  Professor and Head of the Department, Shalyatantra  
Affiliation  Dr.VJD Gramin Ayurved Mahavidyalaya,Patur 
Address  OPD NO 18 Department of Shalyatantra Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka Mata Mandir, Patur,Tal-Patur,Dist-Akola Pin-444501 MAHARASHTRA INDIA

Akola
MAHARASHTRA
444501
India 
Phone  9850500860  
Fax    
Email  gayatriakola@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gayatri Mawale  
Designation  Professor and Head of the Department, Shalyatantra  
Affiliation  Dr.VJD Gramin Ayurved Mahavidyalaya,Patur 
Address  OPD NO 18 Department of Shalyatantra Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka Mata Mandir, Patur,Tal-Patur,Dist-Akola Pin-444501 MAHARASHTRA INDIA

Akola
MAHARASHTRA
444501
India 
Phone  9850500860  
Fax    
Email  gayatriakola@gmail.com  
 
Source of Monetary or Material Support  
Department Of Shalyatantra,Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka Mata Mandir, Patur,Tal-Patur,Dist-Akola Pin-444501 MAHARASHTRA INDIA 
 
Primary Sponsor  
Name  Dr.VJD Gramin Ayurved Mahavidyalaya 
Address  Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka Mata Mandir, Patur,Tal Patur,Dist Akola Pin-444501 MAHARASHTRA INDIA  
Type of Sponsor  Research institution and hospital 
 
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 Hemant Nanaji Thorat   Department Of Shalyatantra Dr VJD Gramin Ayurved Mahavidyalaya  Dr VJD Gramin Ayurved Mahavidyalaya near Renuka Mata Mandir Patur Tal Patur Dist Akola Pin 444501 MAHARASHTRA INDIA
Akola
MAHARASHTRA 
7021443835

hthorat122@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B968||Other specified bacterial agents as the cause of diseases classified elsewhere. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Dushtavranprashaman lepa, Reference: Sharangdhar Uttar Khanda 11 Adhyaya 91 Shloka, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Local Application
2Comparator ArmDrugOther than Classical(1) Medicine Name: Betadine Ointment , Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Local Application
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details 

1. Patient Having Signs and Symptoms of Dushta Vrana (Infected Wound).
2. Age 20-60 Yrs.
3. Patient of Either Sex Will Be Selected.
4. Dushta Vrana within Size Length Up to 5cm, Depth Up to 0.5 cm.
5. Superficial wound involving only epidermis and dermal papillae. 
 
ExclusionCriteria 
Details  1. Patient Suffering from Major Illness Like Cirrhosis, Ascites, Renal failure,
DM,TB, Leprosy, Pregnancy, Jaundice, Varicosity, HIV, HBsAg, Malnutrition.
2. Patient With Malignancy.
3. Bleeding Disorder (Increased BT & CT).
4. Complex & Multiple Wound.
5. Diabetic wound.
6. Anaemic Patient Hb less than 9 g/dL.
7. Septicemia And Operative Wounds.
8. Medicolegal Cases. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Symptoms Like1)Vedana (Pain)
2)Kandu (Itching)
3)Varna (Color)
4)Gandha (Smell)
5)Strava (Discharge)
6)Slough
7)Granulation Tissue 
3,5,7,10,15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in Overall Symptoms   As per Follow up of patient mentioned  
 
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   N/A 
Date of First Enrollment (India)   20/03/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Ayurveda is that which deals with Ayulife or longevity and Veda science
or knowledge.
 Ayurveda is a collection of principles of healthy living that evolved from the
time of appearance of man on earth. This system is older than the Greek and
Egyptian medicine. It is known to the wider world as a New Age Medicine and it is
also called the mother of Healing.
DEFINATION:
Wound is a Break in Integrity of the Skin or tissue Often, Which May Be
Associated with disruption of the structure And function.
 As a scar of a wound never disappears even after complete healing and its
imprint persists life long, it is called vrana.
 In Ayurveda, particularly Sushruta has mentioned various types of vrana and
their management which is of prime importance in any surgical practice.
There are 6 Types of Vrana according to Acharya Sushruta –
Chinna,Bhinna,Viddha,Kshata,Picchita,Ghrushta. All the above are Sadyo Vrana
Which Get Converted in Dushta Vrana, if Not treated properly within 7 Days.
 After injury, healing is a natural phenomenon and continues in sequential manner
until the formation as a healthy scar. Usually nature takes complete care during
healing. The defense mechanism of body like phagocytosis & its local enzymatic
action on dead tissue helps to keep wounds clean. But at time when infection is
massive, surface area of wound is very large and slough or necrotic tissue is to much,
this auto cleaning mechanism becomes inadequate. Acharya Sushruta was aware of
these facts and has indicated the process by which these impediments can be
removed thus paving way for uninterrupted healing.
 For the management of dushta vrana he incorporated number of drugs broadly
classified into vranshodhana & vranropana. It is need to find out a rational and
optimal healing compound for the wound management in better
Way.
 There are many measures to create favorable condition for wound healing
such as use of antiseptic solutions and many topical de-sloughing and debridement
agent which promote healing but there are certain drawbacks of these agents like
damage to healthy granulation tissue, local skin etc. Since time immemorial it has
been an ongoing process to search out better remedies in order to overcome the
previous draw backs.
 Acharya Charak has stated that shodhan is perfect treatment for Dushta Vrana.
Infected wounds are more complicated to heal.generally requires
hospitalization but application of Dushtavranprashaman lepa is para-surgical
process which don’t need hospitalization. Also, it is more effective, multipurpose,
economically affordable and easy to use, also there are no chances for allergies.
Use Of Dushtavranprashaman Lepa in Dushta Vrana:
Acharya Sushruta has classified Lepa into three types: 1.Pralepa 2.Pradeha 3.Alepa
,he clearly indicated use of alepa in dushta vrana. Wound having features of
elevated muscular growth, hard, itching, difficult to clean should treated with
lepa.

 
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