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CTRI Number  CTRI/2025/06/089704 [Registered on: 27/06/2025] Trial Registered Prospectively
Last Modified On: 25/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to know the effect of Sarjikadya Ghrita ointment in the treatment of chronic wound/ulcers. 
Scientific Title of Study   A Comparative Clinical study to evaluate the Shodhana and Ropana effect of Sarjikadya Ghrita Ointment over Povidone Iodine Ointment in the Management of Dushta Vrana (Chronic Ulcers). 
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 Chinmayee Sanjay Chamat 
Designation  PG Scholar 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal 
Address  Room No 16, Department of post graduation studies in Shalya tantra, Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, koppal, Karnataka, INDIA, PIN-583231

Koppal
KARNATAKA
583231
India 
Phone  7795832714  
Fax    
Email  stafinacorrens1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mahantesh M salimath 
Designation  Professor 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal 
Address  Room No 16, Department of post graduation studies in Shalya tantra, Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, koppal, Karnataka, INDIA, PIN-583231

Koppal
KARNATAKA
583231
India 
Phone  9845010950  
Fax    
Email  dr_mahantesh@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chinmayee Sanjay Chamat 
Designation  PG Scholar 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal 
Address  Room No 16, Department of post graduation studies in Shalya tantra, Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, koppal, Karnataka, INDIA, PIN-583231

Koppal
KARNATAKA
583231
India 
Phone  7795832714  
Fax    
Email  stafinacorrens1@gmail.com  
 
Source of Monetary or Material Support  
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College post graduate studies and research centre  
 
Primary Sponsor  
Name  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal 
Address  Room No 16, Department of post graduation studies in Shalya tantra, Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Gavimath, koppal, Karnataka, INDIA, PIN-583231 
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 Chinmayee Sanjay Chamat  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal  Room No 16, Department of post graduation studies in Shalya tantra
Koppal
KARNATAKA 
07795832714

stafinacorrens1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L98||Other disorders of skin and subcutaneous tissue, not elsewhere classified. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: SARJIKADYA GHRITA OINTMENT, Reference: YOGARATNAKARA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -TOPICAL APPLICATION OF SARJIKADYA GHRITA OINTMENT OVER DUSHTA VRANA
2Comparator Arm (Non Ayurveda)-Povidone Iodine OintmentPovidone Iodine Ointment in the dosage of 2 mg is applied topically over the wound once a day for the duration of 28 days.
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Wound size upto 5x5x1 cm
wound chronicity upto 2 yrs  
 
ExclusionCriteria 
Details  ischaemic ulcer
uncontrolled T2 Diabetes mellitus and hypertension
HIV HCV and HbsAg positive patients
patients with bleeding disorders 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of objective parameters-
Discharge
Size
Depth
Granulation Tissue 
4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of-
pain
 
Total Study duration per patient-60 days
Treatment Duration-28 days
Follow up day- 45th and 60th day
Assessment done on-
1st day(Before Treatment)
14th day(During Treatment)
28th day(During Treatment)
45th day (After Treatment)
60th day(After Treatment) 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   10/07/2025 
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="0"
Months="6"
Days="10" 
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  
The word “Vrana” denotes “Vrana Gatra Vichurnane[1]” which means tissue disruption. Vrana cannot heal by itself when it is present in Dushta avastha hence Vrana Shodhana is done followed by Vrana ropana for healing of Dushta Vrana. . It can be clinically correlated to chronic ulcers based on lakshanas mentioned by Acharya.
An ulcer is defined as break in the continuity of the covering epithelium - skin or mucous membrane. It may either follow molecular death of the surface epithelium or its traumatic removal [2] and is usually seen affecting human beings at any age. In India a study conducted in 2018 estimated a prevalence rate of Chronic wounds at 4.5% per 1000 population [3]. In contemporary science procedures like Dressings, Topical Antimicrobials, Enzymes (Papain-Urea combinations) ,along with some advanced modalities like Negative pressure wound Therapy , Hyperbaric oxygen therapy, Acellular matrix tissues ,Bio-engineered Allogenic cellular therapies, Stem cell therapies , Hyalomatrix are used[4] but these interventions are not cost effective and not easily available.
According to estimation from the World Health Organization, 80% of the world’s population relies on traditional medicines for their Primary Healthcare [5]. The classical treatments for wound healing which are mentioned in Sushrut Samhita such as Shashti-Upakrama can help in treating Dushta Vrana. Application of Ghrita is one such form which is mentioned in Shashti Upakrama [6].
Sarjikadya Ghrita is Vrana Ropaka, Krimi-kanduhara and Savarnikarana. It is mentioned in Yoga Ratnakar. It contains drugs such as Yava Kshara and Sarjika Kshara which does Chedana, Bhedana and lekhana of Vrana and their Tridoshahara guna helps to remove unhealthy granulation tissue from Dushta vrana. Tankana, Sasyaka and Kampillaka have Antimicrobial property. Harenuka is known for wound healing properties. Sweta khadira present in formulation is known for its Kandughna and Savarnikarana karma. This formulation is told in the form of Ghrita in which Go-Ghrita is used to reduce pain, inflammation and burning sensation in Vrana. For the feasibility of application this Ghrita is further modified into ointment form to facilitate easy application .The ingredients present in this formulation are easily available and cost effective. Hence an attempt is made to evaluate the effect of Sarjikadya Ghrita in ointment form over Dushta Vrana.
 
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