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CTRI Number  CTRI/2023/01/048786 [Registered on: 06/01/2023] Trial Registered Prospectively
Last Modified On: 05/01/2023
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   A Clinical trial to study the effect as Antimicobial, Anti Inflamatory and Healing effect of Mahagouradya Ghrita in patients suffering from Non healing infected wound 
Scientific Title of Study   A Randomized controlled clinical study to evaluate the efficacy as Antimicrobial, Anti inflammatory & healing effect of Mahagouradya Ghrita in the management of Dushta Vrana 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrVishwajit Narayan Patil 
Designation  Assistant Professor in Department of Shalyatantra 
Affiliation  Ayurved Mahavidyalaya, Sion, Mumbai 
Address  Ayurvidya Prasarak Mandals Ayurved Mahavidyalaya and Seth R.V. Ayurved Hospital, near Sion railway station, Sion, Mumbai- 400022
Bhaisaheb Sawant Ayurved Mahavidyalaya Sawantwadi,Maharashtra 416510
Mumbai
MAHARASHTRA
400022
India 
Phone  9049215431  
Fax    
Email  patilvishwajit19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sheela Shankar Kohad 
Designation  Associate Professor in Department of Shalyatantra 
Affiliation  Ayurved Mahavidyalaya, Sion, Mumbai 
Address  Ayurvidya Prasarak Mandals Ayurved Mahavidyalaya and Seth R.V. Ayurved Hospital, near Sion railway station, Sion, Mumbai- 400022
Ayurvidya Prasarak Mandals Ayurved Mahavidyalaya and Seth R.V. Ayurved Hospital, near Sion railway station, Sion, Mumbai- 400022
Mumbai
MAHARASHTRA
400022
India 
Phone  9920752538  
Fax    
Email  sheela.kohad@hotmail.com  
 
Details of Contact Person
Public Query  
Name  DrVishwajit Narayan Patil 
Designation  Assistant Professor in Department of Shalyatantra 
Affiliation  Ayurved Mahavidyalaya, Sion, Mumbai 
Address  Ayurvidya Prasarak Mandals Ayurved Mahavidyalaya and Seth R.V. Ayurved Hospital, near Sion railway station, Sion, Mumbai- 400022
Bhaisaheb Sawant Ayurved Mahavidyalaya Sawantwadi,Maharashtra 416510
Mumbai
MAHARASHTRA
400022
India 
Phone  9049215431  
Fax    
Email  patilvishwajit19@gmail.com  
 
Source of Monetary or Material Support  
Ayurvidya Prasarak Mandals Ayurved Mahavidyalaya and Seth R.V. Ayurved Hospital, near Sion railway station, Sion, Mumbai- 400022 
OPD & IPD PATIENTS OF DEPARTMENT OF SHALYATANTRA APMS AYURVED COLLEGE,SION ,MUMBAI 
 
Primary Sponsor  
Name  VISHWAJIT NARAYAN PATIL 
Address  Ayurvidya Prasarak Mandals Ayurved Mahavidyalaya and Seth R.V. Ayurved Hospital, near Sion railway station, Sion, Mumbai- 400022 
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 
DrVishwajit Narayan Patil  Ayurvidya Prasarak Mandals Ayurved Mahavidyalaya and Seth R.V. Ayurved Hospital  Shalyatantra OPD and Shalyatantra IPD 1st floor of Ayurved Mahavidyalay and Seth R.V. Ayurved Hospital, near Sion railway station, Sion, Mumbai- 400022
Mumbai
MAHARASHTRA 		 9049215431

patilvishwajit19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L979||Non-pressure chronic ulcer of unspecified part of lower leg. Ayurveda Condition: DUSHTAVRANAH, (2) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vartiH, वर्तिः (Procedure Reference: Vranashashti upakrama, Procedure details: Subjects selected having Dushta Vrana. Procedure explained to patient. Bilingual informed consent from subjects before starting the project taken. Clinical examination of each subject done according to case record form. Subjects instructed about the time, dose and mode of local application of Mahagouradya Ghrita on Dushta Vrana. METHOD OF ADMINISTRATION Washed and dried hand thoroughly. Prepare equipment required for Dressing of Vrana. Proper position to the patient given according to )
(1) Medicine Name: Mhagouradya Ghrita, Reference: Gadanigraha prayogakhand Ghritadhikara Pratham 114-118, Route: Topical, Dosage Form: Ghrita, Dose: 1(NA), Frequency: od, Duration: 28 Days
2Comparator Arm (Non Ayurveda)-Cadaxomer iodine ointmentCadaxomer iodine ointment application in Dushta Vrana Route: Topical, Frequency: od, Duration: 28 Days Interval of 1st day,7th day,14th day,21st day,28th day.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with signs and symptoms of Dushta Vrana.
Patients with Dushta Vrana and have controlled diabetes and hypertension.
Patients ready to give written consent.
Size of Vrana up to 8cm x, 5cm x, 1cm (Twakamansa sthit Dushta Vrana).
Dusht Vrana of 1month to 1 year.
Patients 18yrs to 70yrs of age.
Subjects included irrespective of sex and economic status. 
 
ExclusionCriteria 
Details  Ulcer with other disorders e.g. H.I.V, hepatitis etc, Malignant ulcers, Tubercular ulcers, Syphlitic ulcers, Leprosy, Martorels hypertensive ulcers and Patient having history of bleeding disorders.
Patients having embolism, bleeding disorder, arterial occlusion disease other infective skin disorders.
Ulcer having excessive loss of tissues 
 
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 
Antimicrobial, anti inflammatory and healing effect of Mahagouradya Ghrita as local application for 28 days in Dushta Vrana  At Day 1,7,14,21,28 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the Antimicrobial, anti inflammatory and healing effect of Mahagouradya Ghrita and Cadaxomer iodine ointment local application for 28 days in Dushta Vrana.  28 Days 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   20/01/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Ulcer management is emerging as a specialty branch. Ayurveda has described various Kalpas in Samhitas. So, with the new era, Ayurveda can contribute by its wide range of medicaments in ulcer healing. But the management of Vranas, particularly Dusta Vranas (non healing ulcers) is still a challenge for surgeons.
Therefore in the present study, all efforts are first aimed at keeping the Vrana clean during the various stages of its healing.
For the present study, Mahagouradya Ghrita described in Gadanigraha prayogkhand ghrutadhikar will be applied on Dushta Vrana for its management.
Mahagouradya Ghrita contains Gouri (Daruharidra), Nisha, Manjishtha, Jatamansi, Katurohini (Kutaki), Prapoundarik, Yashtimadhu, Bhadramusta (Nagaramotha), Raktachandan, Jatiphala, Nimba, Patola, Karanja Beeja, Katphal, Madhucchishta, Panchavalkal, Ghrita and Kshir. It is mentioned as SarvaVranavishodhana and Vranaropana.
The contents are easily available and are cost effective.
The goal of study is to increase our understanding of antimicrobial, anti inflammatory and healing effect of Mahagouradya Ghrita.
Primary Objective:
To study the effect of Mahagouradya Ghrita as local application for 28 days as antimicrobial, anti inflammatory and healing in Dushta Vrana on the basis of Pus/Slough culture and Tissue cytology.
Secondary Objective:
To study comparison of Mahagouradya Ghrita as local application and Cadaxomer iodine ointment as local application for 28 days as antimicrobial, anti inflammatory and healing effect in Dushta Vrana on the basis of Pus/Slough culture and Tissue cytology.

Hypothesis:
1) Alternate Hypothesis H1(a)– Mahagouradya Ghrita is effective as antimicrobial, anti inflammatory and healing in the management of Dushta Vrana.
2) Alternate Hypothesis H1(b)- Mahagouradya Ghrita is more effective than Cadaxomer iodine ointment as antimicrobial, anti inflammatory and healing in the management of Dushta Vrana.
3) Null Hypothesis H0– Mahagouradya Ghrita is not effective as antimicrobial, anti inflammatory and healing in the management of Dusta Vrana.
 
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