| CTRI Number |
CTRI/2025/10/095603 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Use Jeerakghrit And Silversulfadiazine In The treatment Of Burns |
|
Scientific Title of Study
|
Comparative Clinical Study Of Jeerakghrit and Silversulfadiazine In The Management Of Dagdhavrana w.s.r. To Burns |
| 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 Lakshya Dahiya |
| Designation |
MS PG Scholar |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalaya Khurja |
| Address |
Opd No.5 Shalya Tantra OPD, Ground Floor PLRD Hospital ,Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalaya Khurja Bulandshahr Uttarpradesh 203131
Roon No. 25 Shalya Tantra Department, Third floor Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalaya Khurja Bulandshahr Uttarpradesh 203131
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
07088735564 |
| Fax |
|
| Email |
lakshyadahiya97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Nayak |
| Designation |
Professor Department Of Shalyatantra |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalaya Khurja |
| Address |
Opd No.5 Shalya Tantra OPD, Ground Floor PLRD Hospital ,Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalaya Khurja Bulandshahr Uttarpradesh 203131
Roon No. 25 Shalya Tantra Department, Third floor Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalaya Khurja Bulandshahr Uttarpradesh 203131
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
7740931315 |
| Fax |
|
| Email |
shikhanayak24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shikha Nayak |
| Designation |
Professor Department Of Shalyatantra |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalaya Khurja |
| Address |
Opd No.5 Shalya Tantra OPD, Ground Floor PLRD Hospital ,Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalaya Khurja Bulandshahr Uttarpradesh 203131
Roon No. 25 Shalya Tantra Department, Third floor Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalaya Khurja Bulandshahr Uttarpradesh 203131
UTTAR PRADESH
203131
India |
| Phone |
7740931315 |
| Fax |
|
| Email |
shikhanayak24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pharmacy Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalaya Khurja Bulandshahr Uttarpradesh 203131 |
|
|
Primary Sponsor
|
| Name |
Dr Lakshya Dahiya |
| Address |
Opd No.5, Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalaya Khurja Bulandshahr Uttarpradesh 203131 |
| 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 Lakshya Dahiya |
Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalaya Khurja |
Opd No.5, Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalaya Khurja Bulandshahr Uttarpradesh 203131
Bulandshahar
UTTAR PRADESH |
07088735564
lakshyadahiya97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics CommitteVaidya Yagya Dutt Sharma Ayurved Mahavidhyalaya Khurja Bulandshahr |
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: DAGDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: jeerakghrit, Reference: bhaishajyaratnawali18/48 sadhyovranachiktsa adhyay, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -wound to be kept under aseptic conditions | | 2 | Comparator Arm (Non Ayurveda) | | - | silversulfadiazine | topical antibiotic cream used to prevent and treat infection in burn wounds. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of the age group above 18years and below 60years.
Patients of both sexes are included.
Diagnosed case of 1 st and 2 nd degree burns.
Burn percentage - 5% - 10%
Patient who will be ready to give written consent.
Known case of burns, 24 – 48 hours back.
Patients with burns on their extremities and trunk. |
|
| ExclusionCriteria |
| Details |
Diagnosed case of 3 rd and 4 th degree burns.
Patients of the age group below 18 years and above 60years will be excluded.
Patients with a concurrent systemic disease like Diabetes mellitus,Hypertension.
Patients who are known case of HIV,HCV,HbSAg
Patients who are known case of burns since more than 48 hours.
Patients with burn on their head and perenieum.
Burn percentage – less than 5% and more than 10% |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement of redness, burning sensation, pain, discharge and healing index of burnt area |
on 1st, 7th, 14th and 21st day assessment of redness, burning sensation, pain, discharge and healing index of burnt area will be done. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| how many signs & symptoms are resolved of the patient. |
assessment will be done at 1st 7th 14th & 21st day |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="0"
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
|
Burns are injuries to the skin and underlying tissues caused by heat, chemicals, electricity, radiation, or friction. Their severity is determined by the depth of damage, percentage of body surface area involved, and location. Burns are classified into four degrees: first-degree (superficial, red, painful) to fourth-degree (extending to muscle and bone). Treatment generally focuses on fluid resuscitation, pain management, infection prevention, and promotion of wound healing, with deeper burns often requiring surgical intervention such as skin grafting.
In the present study, the focus is on first- and second-degree superficial burns, where topical applications (lepa) are the primary mode of treatment. In modern medicine, silver sulfadiazine and other silver-based preparations are commonly used due to their antimicrobial action. In Ayurveda, several ghrita-based lepas are described for wound management; among them, Jeerak Ghrita is noted for its healing and soothing properties.
For this clinical trial, 60 patients aged between 18 and 60 years will be selected according to predefined inclusion and exclusion criteria. The duration of the study will be 15-20 days and follow up of 7 14 21 30 days from the date treatment started. cured patient gets more than 90% relief from symptoms. |