| 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
|
|
|
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
|
|
|
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. |