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
|
|
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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Drug | Classical | | (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. | 2 | Intervention Arm | Drug | Classical | | (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. |