FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/08/027425 [Registered on: 27/08/2020] Trial Registered Prospectively
Last Modified On: 26/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ksharaplota treatment in Dushtavrana  
Scientific Title of Study   Study the Efficacy of Kshraplota in Dushta Vrana W.S.R.to infected wound 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anantkumar Shekokar 
Designation  Professor 
Affiliation  Shri Vivekananda Nursing Home Trust Ayurveda college 
Address  Depertment of Shalya Tantra Shri Vivekananda Nursing Home Trust Ayurveda college Rahuri
NIL
Nanded
MAHARASHTRA
413706
India 
Phone  986076534  
Fax    
Email  dranantkumarshekokar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anantkumar shekokar 
Designation  Professor 
Affiliation  Shri Vivekananda Nursing Home Trust Ayurveda college 
Address  Department of Shalya Tantra Shri Vivekananda Nursing Home Trust Ayurveda college Rahuri
NIL
Ahmadnagar
MAHARASHTRA
413706
India 
Phone  986076534  
Fax    
Email  dranantkumarshekokar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anantkumar shekokar 
Designation  Professor 
Affiliation  Shri Vivekananda Nursing Home Trust Ayurveda college 
Address  Shri Vivekananda Nursing Home Trust Ayurveda college Rahuri

Ahmadnagar
MAHARASHTRA
413706
India 
Phone  986076534  
Fax    
Email  dranantkumarshekokar@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda College Nanded 431601 
 
Primary Sponsor  
Name  Dr Anantkumar V Shekokar 
Address  Shri Vivekananda Nursing Home Trust Ayurveda college Rahuri 
Type of Sponsor  Other [SELF] 
 
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 Anantumar Shekokar  Government Ayurved College   Department of Shalya Tantra
Nanded
MAHARASHTRA 
986076534

dranantkumarshekokar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Vivekananda Nursing Home Trust Ayurveda college Rahuri  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: T07||Unspecified multiple injuries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Application of Ksharaplota  In this group patient of infected wound will be washed with Normal Saline followed by local application of Ksharaplota once in a day and properly bandaged with sterile dressing On the next day Ksharaplota will change and in this way it will continue upto appearance of ShudhdavranaLakshanas sign of healing wound or upto 14 days whichever will earlier  
Comparator Agent  NOT APPLICABLE   NOT APPLICABLE 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  in the present study dushtavrana patients will be selected from the opd /Ipd of department of shalyatantra having sign of dushtavrana upto 6 cm length and breath 6 cm over extrimities. 
 
ExclusionCriteria 
Details  Hb% lessthan 10 gm%.Malnourish patient (as per age ,height and weightproportion.Bleeding disorder.diabetes .AIDS,Tuberculosis,Hepatitis,Malaginancy, vericose ulcer.DVT.  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Efficacy of Ksharaplota in Dushtavrana (infected wound)  Efficacy of Ksharaplota in Dushtavrana (infected wound) in 4 years 
 
Secondary Outcome  
Outcome  TimePoints 
Chedana,Bhedana,Lekhana,shodhana,Ropana and wound healing properties of ksharaplota in Dushtavrana(Infected wound )  4 years 
 
Target Sample Size   Total Sample Size="435"
Sample Size from India="435" 
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/ Phase 3 
Date of First Enrollment (India)   30/08/2020 
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="3"
Months="11"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Vrana  ( wound and ulcer) & process of healing is the soul of Shalyatantra Chikitsa (Surgical treatment ) .  Dushta Vrana means getting vitiated by Dosha & hence Dushta Vrana or infected wound is characterized by bad smell, abnormal color with profuse discharge, severe pain and longer healing time .  The severity of infected wounds and their vast range of etiologies,  The treatment  is cleaning & dressing the wound or it can be more extensive.  It  may require surgical intervention to close  the wound and stabilize the patient. Acharya Sushruta defines Kshara as the substance possessing Ksharana and Kshanan properties.

Ksharaplota formulation was selected and applied over the affected infected wound with the help of gauze piece. During the preparation of Ksharaplota, it is coated with Snuhi kshira, Apamarga kshara & Haridra. All these drugs are Shodhana & Ropana . It was observed that Ksharaplota has the properties as sustained release of drug, absorbs discharges, less painful & easily acceptable by the patient with excellent Sodhana & Ropana Karma. The clinical study has been done on 438 patients, selected randomly and divided in two groups. Group A 220 patients  i.e. trial group ,were treated with local application of Ksharaplota . The Group B 218 patients i.e. control group, were treated with Gold standard . The clinical assessment was done on the basis of clinical presentation of Dushta Vrana,(Infected wound) before and after the treatment.

As grading used for assessment of parameters which were ordinal in nature, “Wilcoxon Signed Ranks test” was used for within the group assessment (i.e. before and after treatment of a group). For between the group assessment of parameters, Mann Whitney – U test was applied. We had  tested hypothesis for each parameter and result was interpreted accordingly. The level of significance was kept at 5% (P=0.05). And  the result of the present study found significant .

 
Close