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CTRI Number  CTRI/2018/07/014875 [Registered on: 16/07/2018] Trial Registered Prospectively
Last Modified On: 11/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Wound Healing Property of Ayurvedic Ointment 
Scientific Title of Study   Vrunaropana Effect Of Durvanisha Ointment In Shuddhavruna, A Randomised Controlled Clinical Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivanarayan Prasad Gupta 
Designation  PG Scholar 
Affiliation  KAHERs Shri B M K Ayurveda Mahavidyalaya 
Address  KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur, Belagavi Karnataka 590003

Belgaum
KARNATAKA
590003
India 
Phone  8051432396  
Fax    
Email  drshivanarayangupta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivanarayan Prasad Gupta 
Designation  PG Scholar 
Affiliation  KAHERs Shri B M K Ayurveda Mahavidyalaya 
Address  KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur, Belagavi Karnataka 590003


KARNATAKA
590003
India 
Phone  8051432396  
Fax    
Email  drshivanarayangupta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Santosh Y M 
Designation  Reader Dept of Shalya Tantra 
Affiliation  KAHERs Shri B M K Ayurveda Mahavidyalaya 
Address  KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur, Belagavi Karnataka 590003

Belgaum
KARNATAKA
590003
India 
Phone  8660800928  
Fax    
Email  drmysantosh@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 
 
Primary Sponsor  
Name  KAHERs Shri B M K Ayurveda Mahavidyalaya 
Address  KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
KAHERs Shri B M K Ayurveda Mahavidyalaya  KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivanarayan Prasad Gupta  KLE Ayurveda Hospital  Dept of Shalya Tantra - OPD No 08 & IPD patients of KLE Ayurveda Hospital Shahapur Belagavi 590003
Belgaum
KARNATAKA 
8051432396

drshivanarayangupta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee KAHER s Shri B M Kankanwadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital Shahapur Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Either sex between 20-70 years of age group. Patients with the Laxanas of Shuddha Vruna ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Durvanisha ointment   Drugs required for the preparation of Durvanisha ointment will be collected from KLEs GMP Certified Ayurved Pharmacy, Khasbag, Belagavi and natural habitat.Durvanisha ointment will be preparaed in the Dept of Rasashastra & Bhaishajyakalpana adopting proper SOP under the supervision of experts.Control drug will be procured from GMP certified KLE’s Ayurveda Pharmacy, Khasbag. The prepared drug will be applied externally for 7 days 
Comparator Agent  Jatyadi tail   Its a ayurveda medicinal preparation in the Oil base which will be applied externally for 7 Days  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Either sex between 20-70 years of age group.
Patients with the Laxanas of ShudhaVrana
 
 
ExclusionCriteria 
Details  Patients suffering from ashuddha vruna (wounds associated with systemic diseases like diabetes mellitus, tuberculosis, malignant wounds, HbsAg, HIV I & II). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The Durvanisha ointment is helpful in treating shuddha Vruna  0th, 7th, 15th 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/10/2018 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The Vruna is one which causes gatravichurnana and does the vivarnata of the shareera which is described as a break in the continuity of tissue, from violence or trauma and is regarded as healed if there is a restoration of the wounded or inflamed tissue to normal condition. Wound healing is an important biological process involving tissue repair and regeneration and various stages. Worldwide prevalence of wounds is 1%, estimated that 1.5 million cases of traumatic wounds found every year, whereas an Indian perspective of hospital based study shows diabetes (23%), venous disease (11%) and trauma (13%), and were the important causes of extremity wounds. We get the reference of Vruna description in detail in regards to definition, classification and management in the classics. Its effective management for a surgeon is the basic skill required on which the outcome of surgery revolves. There was, however, a hundred percent (100 %) healing in the animals treated with ointments containing 100mg/g of Haridra(Curcuma longa), and Durva (Cynodon dactylon) in cationic emulsifying agent after treatment, as the wound sizes reduced to zero. Many herbal preparations have been tried in the past research studies as vruna ropana but they had their own drawbacks like they have time consuming. So keeping this as main goal the present study is under taken to evaluate the efficacy of Durvanisha ointment in clinical trial.

 
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