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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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