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CTRI Number  CTRI/2025/06/088980 [Registered on: 17/06/2025] Trial Registered Prospectively
Last Modified On: 16/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical comparative study for efficacy of jatyadi ghrita with jeerak ghrita as an external application in the management of agnidagdha vrana (second degree burn)  
Scientific Title of Study   Clinical Comparative study for efficacy of Jatyadi Ghrita with Jeerak Ghrita as an external application in the management of Agnidagdha Vrana (Second Degree Burn)  
Trial Acronym  NIl 
Secondary IDs if Any  
Secondary ID  Identifier 
NIl  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHRIKANT RUKHMANRAO GAIKWAD  
Designation  Post graduate scholar 
Affiliation  ASHVIN RURAL AYURVED COLLEGE MANCHI HILL SANGAMNER 
Address  ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL. SADHVI PREETISUDHAJI MAHARAJ NAGAR,MANCHI HILL,ASHVI BK,TAL.SANGAMNER DIST.AHMADNAGAR MAHARASHTRA
ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL. SADHVI PREETISUDHAJI MAHARAJ NAGAR,MANCHI HILL,ASHVI BK,TAL.SANGAMNER DIST.AHMADNAGAR
Ahmadnagar
MAHARASHTRA
413714
India 
Phone  9370321097  
Fax    
Email  shrikantgaikwad2002@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vd Khandizod Shivapal Gopalrao  
Designation  PROFESSOR  
Affiliation  ASHVIN RURAL AYURVED COLLEGE MANCHI HILL SANGAMNER  
Address  ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL,SADHVI PREETISUDHAJI MAHARAJ NAGAR, MANCHI HILL, ASHVI BK, TAL.SANGAMNER DIST. AHMADNAGAR

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  8975780848  
Fax    
Email  drkhandizod1964@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SHRIKANT RUKHMANRAO GAIKWAD 
Designation  Post graduate scholar 
Affiliation  ASHVIN RURAL AYURVED COLLEGE MANCHI HILL SANGAMNER 
Address  ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL. SADHVI PREETISUDHAJI MAHARAJ NAGAR,MANCHI HILL,ASHVI BK,TAL.SANGAMNER DIST.AHMADNAGAR

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  9370321097  
Fax    
Email  shrikantgaikwad2002@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  SHRIKANT RUKHMANRAO GAIKWAD  
Address  ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL. SADHVI PREETISUDHAJI MAHARAJ NAGAR,MANCHI HILL,ASHVI BK,TAL.SANGAMNER DIST.AHMADNAGAR 
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 
SHRIKANT RUKHMANRAO GAIKWAD   ASHVIN RURAL AYURVED COLLEGE MANCHI HILL SANGAMNER   ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL. SADHVI PREETISUDHAJI MAHARAJ NAGAR,MANCHI HILL,ASHVI BK,TAL.SANGAMNER DIST.AHMADNAGAR
Ahmadnagar
MAHARASHTRA 
9370321097

shrikantgaikwad2002@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ASHVIN RURAL AYURVED COLLEGE ETHICAL COMMITEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:T20-T25||Burns and corrosions of external body surface, specified by site. Ayurveda Condition: AGNIDAGDHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: JEERAK GHRITA, Reference: Bhaishajy ratnavali 48/18, Route: Topical, Dosage Form: Ghrita, Dose: 30(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Route of administration EXTERNAL APPLICATION over burn area. DOSE as per requirement.
2Intervention ArmDrugClassical(1) Medicine Name: JATYADI GHRITA, Reference: Sharangdhar samhita madhyam khand 9/58-59, Route: Topical, Dosage Form: Ghrita, Dose: 30(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Route of administration EXTERNAL APPLICATION over burn area. DOSE as per requirement.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients having Agnidagdh vrana superficial second degree burn and second degree burn will be salected.
2. patients of age between 18 to 70 year were taken.
3. salection of patient will be done irrespective of Sex, socioeconomic class, religion.
4.Extent the burn will be decided with the help of Rule of Nine through which the percentage of damage of surface area and depth can be estimated.
Patients up to 20% burn.
Patients first degree burn.
Accidentally burn. 
 
ExclusionCriteria 
Details  1. patients with more than 20% burn area.
2. Deep burn and vital organs area involved.
3. electric burn.
4. patients below ahe 18 year and above 70 year patient.
5. patients suffering from HIV, HBsAg,AIDS.
6.ALL OTHER THAN INCLUSIVE CRITERIA  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
COMPARE EFFICACY OF JATYADI GHRITA AND JEERAK GHRITA AS AN EXTERNAL APPLICATION IN MANEGEMENT OF AGNIDAGDH VRANA(SECOND DEGREE BURN) BY USING SUBJECTIVE AND OBJECTIVE CRITERIA   TOTAL DURETION OF MEDICATION -21 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NOT APPLICABLE  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1 
Date of First Enrollment (India)   02/07/2025 
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="1"
Months="6"
Days="0" 
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 has mentioned various principles and treatment modalities for the prevention as well as cure for the disease. It is mentioned as aim of Ayurveda.
    Ashtanga Ayurveda has mentioned eight different branches of Ayurveda which includes Shalya Tantra which deals with various disorders like anorectal, etc.
    The description of types, clinical features, treatments and complications of Dagdha Vrana written in Ayurveda classics are quite similar to burn injury describe in modern medicine.
   In Ayurvedic classics use of medicinal, surgical and para surgical modalities for treatment of different ailments are given. Para surgical procedures like Agnikarma, Ksharakarma and Raktamokshana were commonly used by Ayurvedic physicians. During the therapy like Agnikarma there were accidental burn injuries known as ‘Pramada Dagdha’ or ‘Ittartha Dagdha’.
    Burn is critical skin condition to care due to involvement of many factor such as skin layers, inflammation and pain. From ancient days it is serious health issue. It is having high mortality rate in the whole world, injuries caused by burns have many more complications like cosmetic disfigurement permanent physical damage and mental trauma.
    Degree of Burn are classified according to its depth ; which includes Superficial 1st degree, superficial 2nd degree, deep 2nd degree, 3rd degree and 4th degree. Here in this study, Second degree superficial burn will be selected for the study. It includes blisters, moist wet, blanches with pressure severe pain to touch. It heals in 7-21 days. Its management includes cleansing, topical agent and sterile dressing.
Need of the study 
   The majority of the patients had third-degree burns followed by second-degree and first-degree burns. World wide.Flame and scald burns were the most common causes in all burn degrees. 
    Dagdha vrana are very frequently and commonly seen in society which are difficult to heal and leads to the intolerable painful condition to the subject. The ayurvedic management leading to better post healing scar reducing cost and hospital stay with nil complications
    The management of wounds was explained under Shashti Upakrama, application of Ghrita is one among them. Now a days silver sulfadiazine is commonly used in burn but this doesn’t avoid post burn complications, affected patients may land into horribly contracted pigmented scar.
     Jeeraka Ghrita is described by Bhaishajya Ratnawali as combination for having of burn wounds reduces the burn discharge and reduce burning sensation of burn area and blister formation. It contains Jeeraka, Ghrita, Rala, Moma and Jala. All this having Vranaghna, Vrana Ropana, Vrana Shodhana properties.
    Jatyadi Ghrita is one of the known formulation used for the management of Vrana or wound healing. It contains Jati, Patol patra, Nimba patra, Haridra etc. all this contains having antimicrobial, analgesic, wound healing properties.
    Here in this study, comparative study of Jeeraka Ghrita and Jatyadi Ghrita will be selected. All this drugs are easily available, easy to apply, affordable, cheap. Therefore, it will be selected for the comparative study.
 
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