| CTRI Number |
CTRI/2024/02/062816 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study on topical herbal creams in burn wound |
|
Scientific Title of Study
|
Development of three-pronged strategy for burn wound management using plant extracts and enzymes |
| 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 Suhas Abhyankar |
| Designation |
Consultant Plastic and Reconstructive Surgeon |
| Affiliation |
Masina Hospital, Masina Hospital Trust |
| Address |
Department of Plastic Surgery, Eric Kharas Burns Unit and Research Center, OPD No 1, 3rd Floor, Masina Hospital, Masina Hospital Trust,
Sant Savta Marg, Byculla East, Mumbai
Mumbai
MAHARASHTRA
400027
India |
| Phone |
986903828 |
| Fax |
|
| Email |
drsvabhyankar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bela Nabar |
| Designation |
Prof and Head |
| Affiliation |
Smt Chandibai Himathmal Mansukhani College |
| Address |
Department of Microbiology,
First Floor, Smt Chandibai Himathmal Mansukhani College,
Ulhasnagar Railway Station Road, Opp. Ulhasnagar Railway Station, Thane District, Ulhasnagar, Maharashtra
Thane
MAHARASHTRA
421003
India |
| Phone |
9322760417 |
| Fax |
|
| Email |
belamsn23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bela Nabar |
| Designation |
Prof and Head |
| Affiliation |
Smt Chandibai Himathmal Mansukhani College |
| Address |
Department of Microbiology,
First Floor, Smt Chandibai Himathmal Mansukhani College,
Ulhasnagar Railway Station Road, Opp. Ulhasnagar Railway Station, Thane District, Ulhasnagar, Maharashtra
MAHARASHTRA
421003
India |
| Phone |
9322760417 |
| Fax |
|
| Email |
belamsn23@gmail.com |
|
|
Source of Monetary or Material Support
|
| RAJIV GANDHI SCIENCE & TECHNOLOGY COMMISSION (RGSTC)
3rd Floor, Apeejay House, Dinshaw Vacha Rd, Near K. C. College, Churchgate, Mumbai, Maharashtra 400020 |
|
|
Primary Sponsor
|
| Name |
RAJIV GANDHI SCIENCE & TECHNOLOGY COMMISSION (RGSTC) |
| Address |
3rd Floor, Apeejay House, Dinshaw Vacha Rd, Near K. C. College, Churchgate, Mumbai, Maharashtra 400020 |
| Type of Sponsor |
Government funding agency |
|
|
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 Suhas Abhyankar |
Masina Hospital, Masina Hospital Trust |
Department of Plastic Surgery, Eric Kharas Burns Unit and Research Center, OPD No 1, 3rd Floor, Masina Hospital, Masina Hospital Trust,
Sant Savta Marg, Byculla East, Mumbai-400027
Mumbai
MAHARASHTRA |
986903828
drsvabhyankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), Masina Hospital Trust |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T202||Burn of second degree of head, face, and neck. Ayurveda Condition: DAGDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tugakshiryadi Ghrit, Reference: Sushrut Sootrasthana Chapter 12. Sloka. 23-24, Route: Topical, Dosage Form: Ghrita, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Samudga, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: 1 mm thick quantity of medicine will be used for wet dressing alternate day till complete healing of burn wound | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Cream Formulation of Aqueous extract, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Samudga, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: 1 mm thick quantity of medicine will be used for wet dressing alternate day till complete healing of burn wound | | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Cream Formulation of Hydro-alcoholic extract, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Samudga, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: 1 mm thick quantity of medicine will be used for wet dressing alternate day till complete healing of burn wound | | 4 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Silver Sulfadiazine Cream, Reference: NA, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 1(mg), Frequency: od, Bhaishajya Kal: Samudga, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: 1 mm thick quantity of medicine will be used for wet dressing alternate day till complete healing of burn wound |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with burn wound of any etiology
2. Patient with 5 to 10 percent of burned surface area
3. Patients with second degree burns.
4. Subjects willing to sign informed consent and to undergo all the study procedure
|
|
| ExclusionCriteria |
| Details |
1. Known allergy or hypersensitivity reaction to epidermal growth factor, silver sulfadiazine or other substances in formulation.
2. Burn wound involving the eyes, ears, nose, mouth & genitals
3. Pregnancy or breastfeeding
4. No underlying diseases that interfere wound healing such as known chronic kidney disease, liver disease, immunocompromised conditions.
5. Treatment with another investigational drug or other intervention (within a specified time frame)
6. History of drug or alcohol abuse
7. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with patient’s participation in, and completion of the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative difference in time required (in days) for complete healing of burn wound |
Baseline visit, every alternate day visit till complete healing of burn wound |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparative evaluation of wound healing process by comparing the mean surface area (percentage healing) of burn wound
2. Comparative assessment of wound discharge, smell, color of burn area, pain during dressing, burning pain at rest, edema, granulation tissue, itching and pigmentation
3. Global assessment for overall change by investigator and subjects
4. Assessment of adverse events.
|
Baseline visit, every alternate day visit till complete healing of burn wound |
|
|
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 2 |
|
Date of First Enrollment (India)
|
23/02/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is an open label, active controlled,
comparative, interventional, prospective clinical study to evaluate efficacy
and safety of topical herbal creams and classical ayurvedic ghrita in burn
wound. The study will be carried out at 1 to 2 centers in India. 1 mm thick
quantity of medicine will be used for wet dressing alternate day till complete
healing of burn wound. Primary objective of the study will be to assess comparative
difference in time required (in days) for complete healing of burn wound. Secondary
objectives of the study will be to assess comparative evaluation of wound
healing process by comparing the mean surface area (percentage healing) of burn
wound, comparative assessment of wound discharge, smell, color of burn area,
pain during dressing, burning pain at rest, edema, granulation tissue, itching
and pigmentation, global assessment for overall change by investigator and
subjects and assessment of adverse events on baseline visit, every alternate
day visit till complete healing of burn wound. |