| CTRI Number |
CTRI/2025/03/081984 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Madhuchistadi Vikeshika on second degree burn |
|
Scientific Title of Study
|
An open randomized controlled clinical trail of Madhuchistadi Vikeshika in Duradagdha Vrana with special reference to 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 |
NILESH DILIP TAMKHANE |
| Designation |
PG Scholar |
| Affiliation |
S.D.S.S Annasaheb Dange Ayurved Medical College, Sangli |
| Address |
OPD no.13, Shalyatantra OPD,Ground floor,Dhanvantari Ayurveda Hospital Ashta, Tal- Walwa,Dist- sangli,Maharashtra, 416301
Hon. Shri. Annasaheb Dange Ayurved Medical College,
Post Graduate & Research Center, Ashta.
Tal-Walwa Dist- Sangli - 416 301(Maharashtra) India.
Sangli
MAHARASHTRA
416301
India |
| Phone |
7276847370 |
| Fax |
|
| Email |
nileshtamkhane2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Jadhav |
| Designation |
Reader |
| Affiliation |
S.D.S.S Annasaheb Dange Ayurved Medical College, Sangli |
| Address |
OPD no.13, Shalyatantra OPD,Ground floor,Dhanvantari Ayurveda Hospital Ashta, Tal- Walwa,Dist- sangli,Maharashtra, 416301
Hon. Shri. Annasaheb Dange Ayurved Medical College,
Post Graduate & Research Center, Ashta.
Tal-Walwa Dist- Sangli - 416 301(Maharashtra) India.
Sangli
MAHARASHTRA
416301
India |
| Phone |
9823279290 |
| Fax |
|
| Email |
sjadhav21066@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Jadhav |
| Designation |
Reader |
| Affiliation |
S.D.S.S Annasaheb Dange Ayurved Medical College, Sangli |
| Address |
OPD no.13, Shalyatantra OPD,Ground floor,Dhanvantari Ayurveda Hospital Ashta, Tal- Walwa,Dist- sangli,Maharashtra, 416301
Hon. Shri. Annasaheb Dange Ayurved Medical College,
Post Graduate & Research Center, Ashta.
Tal-Walwa Dist- Sangli - 416 301(Maharashtra) India.
Sangli
MAHARASHTRA
416301
India |
| Phone |
9823279290 |
| Fax |
|
| Email |
sjadhav21066@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon. Shri. Annasaheb Dange Ayurved Medical College,
Post Graduate & Research Center, Ashta.
Tal-Walwa Dist- Sangli - 416 301(Maharashtra) India. |
|
|
Primary Sponsor
|
| Name |
Dr Nilesh Tamkhane |
| Address |
OPD no.13, Shalyatantra OPD,Ground floor,Dhanvantari Ayurveda Hospital Ashta, Tal- Walwa,Dist- sangli,Maharashtra, 416301 |
| 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 |
| Dr Nilesh Tamkhane |
Hon. Shri. Annasaheb Dange Ayurved Medical College, Post Graduate & Research Center, Ashta. |
Opd no 13,shalyatantra
opd, ground floor,
dhanvantari ayirved
hospital, Ashta Sangli
416301
Sangli
MAHARASHTRA
Sangli
MAHARASHTRA |
7249797378
nileshtamkhane2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Center Ashta Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DURDAGDHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bandhanakarma, बन्धनकर्म | (Procedure Reference: Shastri Ambikadatta K., Sushruta Samhita, Ayurved Tatwa Sandipika hindi commentary, Vol.1., Chaukhamba Prakashan, Varanasi, reprint 2022, Chiktsasthan, Chapter-1, page no.5, Procedure details: application madhuchistadi vikeshika on durdahdga vrana for 15 days )
(1) Medicine Name: madhuchistadi ghrita , Reference: hastri Ambikadatta K., Sushruta Samhita, Ayurved Tatwa Sandipika hindi commentary, Vol.1., Chaukhamba Prakashan, Varanasi, reprint 2022, sutrasthan, Chapter-12, page no.128, Route: Topical, Dosage Form: Ghrita, Dose: 5(ml), Frequency: sos, Duration: 15 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Collagen Sheet | Route: Topical, Frequency: sos, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of Second Degreeburnsup to 15% of TBSA will be selected randomly from OPD of department Shalyatrantra of Ayurveda college hospital irrespective of sex, religion and marital status.
2.Patient of age group 15 to 55 years included. |
|
| ExclusionCriteria |
| Details |
a) Patient suffering from skin diseases and lesions.
b) Burns due to chemical, electrical radiation and deep burn.
c) Patient with known history of Diabetis, coagulopathy, bleeding disorders
and cutaneous manifestation of other illness.
d) Patients sensitive to any contents of MadhuchishtadhiVikeshika |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Madhuchistadi Vikeshika in Managment of Durdagdha Vrana with special reference to Second Degree Burn upto 15% |
15 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of Collagen Sheet on Durdagdha Vrana |
15 DAYS |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
01/07/2025 |
| 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 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
|
Burn is a wound where there is thermal coagulative necrosis of tissue caused by dry heat like flame, radiant heat, electricity, lightning-Ray or Highly heated surface by sun rays (Sunburn).the four types of DadgdhaDURADAGDHA, DURADAGDHA, Samyakdagdha and Atidagdha. madhuchistadighrita is drug which has significant snehan, vedanasthapan, sandhaniya, vranshodhan, ropan, tvachya, and properties. Madhuchishtadighrita is classical polyherbprepration mentioned in Susruta samhita for AganidagdhaVrana hence in present study this classical prepration will be tested for efficacy in the management of DurdadaagdhaVrana. So keeping all above in mind madhuchistadi ghruta is choosen for management of durdaghda vrana as vranaropana. Madhuchistadi vikeshika is applied on patient fro 15 days for every 48 hours for 32 patients. Collagen sheet will be applied to 32 patient for 15 days for every 72 hours and results will be noted. |