| CTRI Number |
CTRI/2025/01/079092 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
STUDY OF TIL YAVA BHASMA IN PLUSHTA DAGDHA VRANA(first degree burn) |
|
Scientific Title of Study
|
OPEN RANDOMIZED CLINICAL CONTROL TRIAL OF TIL YAVA BHASMA IN PLUSHTA DAGDHA VRANA WITH SPECIAL REFERENCE TO FIRST DEGREE BURN. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siddheshwar Namdeo Sanap |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College, Post Graduation Research Center Ashta |
| Address |
Shalya Tantra OPD,Ground Floor, Dhanvantari Ayurvedic Hospital,
Ashta, Tal- Walwa , Dist -Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9921395359 |
| Fax |
|
| Email |
sidsanap.1297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akbar Walandakar |
| Designation |
Professor |
| Affiliation |
Hon. Shri Annasaheb Dange Ayurvedic Medical College, Post Graduation Research Center Ashta |
| Address |
Department of Shalya Tantra,Fifth Floor, Hon. Shri Annasaheb Dange Ayurvedic Medical College, Post Graduation Research Center
Ashta, Tal- Walwa , Dist -Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860181980 |
| Fax |
|
| Email |
akbar.walandkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akbar Walandakar |
| Designation |
Professor |
| Affiliation |
Hon. Shri Annasaheb Dange Ayurvedic Medical College, Post Graduation Research Center Ashta |
| Address |
Department of Shalya Tantra,Fifth Floor, Hon. Shri Annasaheb Dange Ayurvedic Medical College, Post Graduation Research Center
Ashta, Tal- Walwa , Dist -Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860181980 |
| Fax |
|
| Email |
akbar.walandkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurvedic Medical College, Post Graduation Research Center Ashta |
|
|
Primary Sponsor
|
| Name |
Hon Shri Annasaheb Dange Ayurvedic Medical College, Post Graduation Research Center Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurvedic Medical College, Post Graduation Research Center Ashta, tal- Walwa, dist- Sangli |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Siddheshwar Namdeo Sanap |
Hon Shri Annasaheb Dange Ayurvedic Medical College Post Graduation Research Center Ashta |
Shalyatanatra OPD , ground floor,Hon Shri Annasaheb Dange Ayurvedic Medical College Post Graduation Research Center Ashta
Sangli
MAHARASHTRA |
9921395359
sidsanap.1297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurvedic Medical College Post Graduation Research Center institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T310||Burns involving less than 10% of body surface. Ayurveda Condition: PLUSHTADAGDHAH/TUCCADAGDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Til Yava Bhasma , Reference: bhaishjya Ratnavali, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 9 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | silver sulfadiazine cream | Medicine Name SILVER SALPHADIAZINE CREAM
ROUTE LOCAL APPLICATION
DOSE ACCORDING WOUND REQUIRMMENT
FREQUENCUY BD twice a day
DURATION FOR 9 DAYS
|
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with first-degree burns who have less than 10% of TBSA will be selected randomly. |
|
| ExclusionCriteria |
| Details |
patients suffering from skin diseases or lesions.
Burn due to electric radiation or chemicals.
Patient with a known history of Diabetes, coagulopathy, and bleeding disorder.
Burn over face and genital parts. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
TIL YAVA BHASMA is significantly effective in the management of Plushta dagdha vrana
assesment parameter is pain relif and wound healing |
9 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TIL YAVA BHASMA is significantly
Not effective in the management of Plushta dagdha vrana
Til Yava bhasma & Silver Sulfadiazine Cream Equally effective
assesment will be according pain relif & healing of wound |
9 days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
10/02/2025 |
| 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
|
Burn injury involves complex pathology. Burn patients are more predisposed to infection due to suppressed immunity. Burn wound is land for the growth of various microorganisms. Due to the destruction of microcirculation in the burnt area. Also, the rise of antibiotic-resistant organisms is posing a great problem in the use of systemic antibiotics, so to find out easily available, affordable treatment for Burn injury. Til Yava Bhasma is a classical polyherbal preparation mentioned in Bhaishajya Ratnavali exclusively for Aganidagdha Vrana hence in the present study this classical preparation will be tested for efficacy in the management of Plushta Dagdha Vrana. |