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临床试验/CTRI/2022/05/042356
CTRI/2022/05/042356尚未招募4 期

Efficacy of Astymin3 as an add on therapy to standard of care in reduction of hospitalizationand improving wound healing in postoperative patients ARandomized single blind controlled clinical trial

Tablets India Limited1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年2月5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
200
试验地点
1
主要终点
changes in days of hospitalization

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients elected for open abdominal surgeries such as inguinal hernia surgery Cholecystectomy Appendectomy.

排除标准

  • 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.

结局指标

主要结局

changes in days of hospitalization

时间窗: 7 day therapy with follow up at day 0 and day 7

次要结局

  • Wound healing achieved by reduction in surgical site infection(Surgical scar assessment)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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