| CTRI Number |
CTRI/2025/11/097297 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Metformin help reducing inflammation and improve recovery in burn patients |
|
Scientific Title of Study
|
Anti-inflammatory effects of Metformin in adults with moderate to major burns (20-60 percentage TBSA): A Randomised Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Satish Harkal |
| Designation |
Junior resident (Anaesthesiology) |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi. |
| Address |
Department of Anaesthesiology, Pain medicine and Critical Care,
All India Institute of Medical Sciences (AIIMS) New Delhi.
New Delhi DELHI 110029 India |
| Phone |
9156759323 |
| Fax |
|
| Email |
harkalsatish27@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rupavath Ramkumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi. |
| Address |
Room no. 211, 2nd floor,
Burns and Plastic block,
All India Institute of Medical Sciences (AIIMS) New Delhi.
New Delhi DELHI 110029 India |
| Phone |
9592099690 |
| Fax |
|
| Email |
dr.ramkumarnaik09@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Rupavath Ramkumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi. |
| Address |
Room no. 211, 2nd floor,
Burns and Plastic block,
All India Institute of Medical Sciences (AIIMS) New Delhi.
New Delhi DELHI 110029 India |
| Phone |
9592099690 |
| Fax |
|
| Email |
dr.ramkumarnaik09@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS) Ansari Nagar New Delhi , INDIA 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences (AIIMS) New Delhi. |
| Address |
Ansari Nagar East,
New Delhi- 110029. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Satish Harkal |
Burns and Plastic Block All India Institute of Medical sciences New Delhi 110029 |
Burn ICU 5th and 6th floor Burns and Plastic Block All India Institute of Medical sciences Ansari nagar west New Delhi 110029 New Delhi DELHI |
9156759323
harkalsatish27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T31||Burns classified according to extent of body surface involved, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metformin group |
500 mg of metformin administered orally or via nasogastric tube twice daily (total daily dose of 1 g) for 7 days or until ICU discharge, whichever occurs first. |
| Comparator Agent |
Placebo group |
Matching placebo administered orally or via nasogastric tube twice daily for 7 days or until ICU discharge, whichever occurs first. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18–60 years.
2. Burns covering 20–60 percentage of TBSA.
3.Provision of informed consent by the patient or legal representative.
4. Hemodynamically stable.
|
|
| ExclusionCriteria |
| Details |
1. Known history of diabetes mellitus.
2. Serum creatinine greater than 1.5 mg/dL
3. Hepatic dysfunction (AST or ALT greater than 3 times the upper limit of normal).
4. Presence of lactic acidosis or metabolic acidosis.
5. Pregnancy or lactation.
6. Participation in another interventional clinical trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effects of Metformin on Serum levels of CRP, IL-6, Serum Ferritin, and PCT in adult burn patients with. 20-60 percentage of TBSA injuries. |
Till 7 days of ICU admission or till discharge whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the impact of metformin on clinical outcomes, including:
a. Sequential Organ Failure Assessment (SOFA) score
b. Length of ICU stay
c. Incidence of sepsis (as per CDC criteria)
To monitor the safety and tolerability of metformin in the study population |
Till 7 days of icu admission |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
22/11/2025 |
| 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="2" Months="0" 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
|
| This study explores a novel use of a well-known drug to address a serious unmet need in burn care, with the potential to transform treatment protocols and improve survival. 1. High Burden of Burn-Related Inflammation Burn injuries involving 20–60 percent of the TBSA induce a strong systemic inflammatory response. This excessive inflammation often leads to life-threatening complications such as sepsis, acute organ failure, and death. Current treatments primarily focus on supportive care, with limited options to directly modulate the inflammatory response. 2. Need for Adjunctive Therapies Despite advances in critical care, mortality and morbidity rates in moderate to severe burn patients remain high. Introducing safe, accessible, and cost-effective therapies that can reduce inflammation could significantly improve patient outcomes. 3. Metformin’s Unique Therapeutic Potential Metformin is widely used, well-tolerated, and inexpensive. Its anti-inflammatory properties, mediated via AMPK activation and NF-kappa B inhibition, provide a strong biological rationale for investigating its use beyond diabetes—especially in conditions characterized by excessive cytokine release, such as burns. 4. Lack of Prior Research in Burn Populations While metformin’s anti-inflammatory effects have been studied in other diseases (e.g., cardiovascular disease, diabetes, cancer), there is limited research specifically evaluating its role in burn-induced inflammation. This study would help fill that critical knowledge gap. 5. Potential to Improve Clinical Outcomes If metformin is shown to effectively reduce biomarkers like CRP, IL-6, Serum Ferritin and PCT in burn patients, it may lead to reduced sepsis rates, faster recovery, shorter ICU stays and lower healthcare costs, ultimately enhancing quality of care. | |