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CTRI Number  CTRI/2025/01/079540 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Study Effect Of Ayurvedic drug in Management Of Vran with Reference To Lacerated Wound 
Scientific Title of Study   A Randomised Controlled Clinical Trial To Study The Efficacy Of Manjisthadi Tail Local Application in The Management Of Kshataj Vran With Special Reference To Lacerated 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  Neha Banduji Dhongade  
Designation  MS Shalyatantra Scholar  
Affiliation  Dr Vjd Gramin Ayurvedic Mahavidyalaya Patur 
Address  OPD no 18, Department of Shalyatantra Dr Vjd Gramin Ayurvedic Mahavidyalaya Patur Near Renuka Mata Mandir Tq Patur Dist Akola Maharashtra

Akola
MAHARASHTRA
444501
India 
Phone  7741968495  
Fax    
Email  neha223925@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 
Address  OPD no 18, Department of Shalyatantra Dr Vjd Gramin Ayurvedic Mahavidyalaya Patur Near Renuka Mata Mandir Tq Patur Dist Akola Maharashtra

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 
Address  OPD no 18, Department of Shalyatantra Dr Vjd Gramin Ayurvedic Mahavidyalaya Patur Near Renuka Mata Mandir Tq Patur Dist Akola Maharashtra

Akola
MAHARASHTRA
444501
India 
Phone  9850500860  
Fax    
Email  gayatriakola@gmail.com  
 
Source of Monetary or Material Support  
OPD no 18 , Department of Shalyatantra,Dr VJD Gramin Ayurveda Mahavidyalaya Patur Tal-Patur Dist-Akola State Maharashtra Country India  
 
Primary Sponsor  
Name  Department of Shalyatantra Dr Vjd Gramin Ayurvedic Mahavidyalaya Patur  
Address  Department of Shalyatantra Dr Vjd Gramin Ayurvedic Mahavidyalaya Patur Near Renuka Mata Mandir Tq Patur Dist Akola Maharashtra India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Neha Bandu Dhongade  Dr. VJD Gramin Ayurved Mahavidyalaya  OPD No.18, Department of Shalyatantra, Dr.VJD Gramin Ayurved Mahavidyalaya, Near Renuka Mata Mandir, Patur, TQ. Patur, Dist. Akola, Maharashtra, 444501.
Akola
MAHARASHTRA 		 7741968495

neha223925@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,DR VJD Gramin Ayurved Mahavidyalaya,Patur, Akola  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:T07||Unspecified multiple injuries. Ayurveda Condition: KSHATAH NIPATITA-SADYOVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Povidone Iodine 5 %Drug Information _ Control group Povidone ointment 5%
2Intervention ArmDrugClassical(1) Medicine Name: Manjisthadi tail, Reference: Sushrut Samhita Chikitsasthan 2/74, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  A)Patient having age between 20to 60 years.
B) Patients irrespective of gender, economic class, caste, religion.
C) Patient having sign and symptoms of kshataj vrana having area less then length 5 cmx
5cm& max depth: upto dermis(approx) be randomly selected. 
 
ExclusionCriteria 
Details  A] Known cases of HIV, Hepatitis B, TB,any systemic disease like DM.
B] Bleeding disorders
C] Patient on aspiring and others anti platelets drug
D]Tubercular Ulcers, venous ulcer, leprotic ulcer, malignant ulcer, Burns etc.
E] Wounds having excessive loss of Tissues i.e.wound include bone, and tendon injury,
exposed bone
F] Patient suffering from chinn Vrana(excise wound)
G] Bhinn Vrana(stab injury)
H] Picchita Vrana(crushed injury)
Vidhha Vrana(punctured wound)
J] Complex wound like wound associated with fracture, ligament tear, tendon
rupture, wound with profuse continuous bleedind which needs surgical haemostasis.
K] All medico-legal cases
Withdrawal Criteria –
-If patient is not willing to continue the treatment
-Patient unable to tolerate the treatment.
-Any unknown adverse drug reaction of treatment on
patient.Patient fails to report for follow up or irregular medication. 
 
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 
Decrease in Symptoms   15 days  
 
Secondary Outcome  
Outcome  TimePoints 
Kshataj Vrana will be cleared  15 days  
 
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   N/A 
Date of First Enrollment (India)   31/01/2025 
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="1" 
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  
Ayurveda is a life science and life supporting science, having widespread approaches for
health with more scope of trials to confirm principles as well as therapeutic effects of
herbs and medicines, which is the need of future to make Ayurveda more acceptable
globally. A wound is an interruption to skin integrity caused by physical trauma or disease.
Everybody experiences wounds and most wounds heal uneventfully; however, a significant
minority of people have wounds that are very slow to heal or which do not heal at all.
These more complex wounds, which are mainly managed by community nurses, were the
focus of this programme of research. Samhitas of Ayurveda have emphasized at various
places to take care of wounds which occur due to vitiated dosha or any trauma. Sushruta a
golden era surgeon of India was much ahead of his time in expounding and practicing the
concept of vrana shodhana and ropana. The shalya chikitsa brings out clearly that vrana
(wound) is the most significant surgical entity and knowledge of its effective management
for a surgeon is the basic skill required on which outcomes of surgery revolves.
Shalyatantra is one of the Ashtang of Ayurveda. Acharya sushrut is father of surgery. He
has given wide description of wound and its management. Wound healing is central theme
of Sushrut Samhita. Problems of wound healing has drawn attention of large number of
scientists all over the world. The importance of wound healing has long been recognized
as fundamentally essential for the study of surgical practices. Some of the principle as
described by Sushrut not only comparable, but they are favorable and superior with recent
modern advances in the management of wound. The Shalyachikitsa brings out clearly that
vrana (wound) is the most significant surgical entity and knowledge of its effective
management for a surgeon is the basic skill required on which outcomes of surgery
revolves. There is a constant need to deal with wound as well as problems in healing in
different surgical disorders.
 
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