FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/05/042356 [Registered on: 02/05/2022] Trial Registered Prospectively
Last Modified On: 02/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Amino acids in wound healing 
Scientific Title of Study   Efficacy of Astymin 3 as an add on therapy to standard of care in reduction of hospitalization and improving wound healing in postoperative patients A Randomized single blind controlled clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tharun Ganapathy C 
Designation  Associate Professor 
Affiliation  SRM Medical College Hospital And Research Centre 
Address  SRM Medical College Hospital And Research Centre Department of General Surgery SRM Nagar Potheri Chengalpattu Tamil Nadu

Kancheepuram
TAMIL NADU
603203
India 
Phone  044-47432567  
Fax    
Email  tharungc@srmist.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Tharun Ganapathy C 
Designation  Associate Professor 
Affiliation  SRM Medical College Hospital And Research Centre 
Address  SRM Medical College Hospital And Research Centre Department of General Surgery SRM Nagar Potheri Chengalpattu Tamil Nadu

Kancheepuram
TAMIL NADU
603203
India 
Phone  044-47432567  
Fax    
Email  tharungc@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  Melvin George 
Designation  Professor 
Affiliation  SRM Medical College Hospital And Research Centre 
Address  SRM Medical College Hospital And Research Centre Department of Clinical Pharmacology SRM Nagar Potheri Chengalpattu Tamil Nadu

Kancheepuram
TAMIL NADU
603203
India 
Phone  044-47432567  
Fax    
Email  melvingeorge2003@gmail.com  
 
Source of Monetary or Material Support  
STUDY SAMPLES TO BE PROVIDED BY TABLETS INDIA LIMITED 
 
Primary Sponsor  
Name  Tablets India Limited 
Address  72 Marshall Road Egmore Chennai 600008 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
Nidhi Mariam George  SRM Medical College Hospital and Research Centre  SRM Medical College Hospital And Research Centre Department of General Surgery SRM Nagar Potheri Chengalpattu Tamil Nadu
Kancheepuram
TAMIL NADU 
04447432567

drnidhigeorge@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Astymin 3 20ml   Astymin 3 20ml for a period of 1 week along with the standard treatment 
Comparator Agent  standard of care   standard of care for 7 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients elected for open abdominal surgeries such as inguinal hernia surgery
Cholecystectomy
Appendectomy
 
 
ExclusionCriteria 
Details  Laparoscopic surgeries
Patients with type 1 or type 2 diabetes m
Chronic renal failure
Acute kidney injury
Chronic alcoholic patients
Smokers
Obesity BMI more than 25
Any major surgical procedure involving excessive blood loss more than 1 liter
COPD
CHF and anemia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
changes in days of hospitalization  7 day therapy with follow up at day 0 and day 7 
 
Secondary Outcome  
Outcome  TimePoints 
Wound healing achieved by reduction in surgical site infection

Surgical scar assessment

Increase in epithelization turnover

Surgical scar assessment

Increase in epithelization turnover 
7 day therapy with follow up at day 0 and day 7 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 4 
Date of First Enrollment (India)   02/05/2022 
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="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Surgical incisions lead to localised damage to the skin, muscle and underlying tissue. This is complicated with shear, friction or unrelieved pressure, usually over bony prominences. They are associated with many health conditions that cause prolonged bed rest, prolonged hospitalization, immobility, inactivity or poor sensation and can significantly contribute to morbidity and mortality, particularly in the aged population.

Surgical wound often fail to heal in a timely and orderly manner, resulting in a chronic non-healing wound. Many intrinsic and extrinsic factors have been identified that can disrupt the wound healing processes of haemostasis, inflammation, proliferation, angiogenesis and remodelling. One of the factors gaining more interest for its impact on wound healing processes is nutritional status.

Arginine is a semi-essential amino acid because even though the body normally makes enough of it, supplementation is sometimes needed during critical illness and severe trauma. There have been numerous research studies focusing on using arginine to enhance wound healing and pressure ulcer prevention. It is required for promotion of nitrogen balance, cell proliferation, T lymphocyte function and collagen accumulation. It also changes into nitric oxide, which is known for its vasodilatory and angiogenic properties.

Glutamine is conditionally essential amino acid because it can be manufactured in the body, but under extreme physical stress the demand for glutamine exceeds the body’s ability to make it. Adequate amounts of glutamine are generally obtained through diet alone because the body is also able to make glutamine on its own. Certain medical conditions, including injuries, surgery, infections, and prolonged stress, can deplete glutamine levels. Since glutamine plays a key role in the immune system, a deficiency in this nutrient can significantly slow the healing process.

Beta-hydroxy-Beta methylbutyrate (HMB) is a metabolite of leucine, an essential amino acid. HMB supplementation was associated with increased muscle mass accretion. HMB appears to assert its effect via inhibiting muscle proteolysis and modulating protein turnover.

Recently, arginine has been found to accelerate wound healing in combination with HMB and glutamine. It was shown that healthy subjects who are supplemented orally with arginine had a significant rise in plasma arginine and ornithine levels that led to enhanced rate of collagen synthesis. In studies, a HMB/Arginine/Lysine mixture increased protein turnover in elderly patients over a year long period. We hypothesize that due to the above benefits there would be reduction in days of hospitalization in post-surgical patients with amino acids.

 
Close