跳至主要内容
临床试验/RBR-56z7knn
RBR-56z7knn进行中(未招募)不适用

Impact of nutritional counseling including propolis supplementation in patients with COVID-19

Universidade Federal de Ouro Preto0 个研究点目标入组 120 人开始时间: 2022年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120

研究概览

简要总结

Abstract: Sepsis is defined as the presence of life-threatening organ dysfunction secondary to a dysregulated host response to an infection. Excessive production of free radicals, depletion of endogenous antioxidant levels, and increased inflammatory mediators during sepsis contribute to major deleterious systemic effects, such as tissue hypoxia and organ failure. Bioactive substances have been studied using experimental models and clinical trials, opening new alternatives for the treatment of sepsis. Among natural substances, propolis stands out, exhibiting antimicrobial, anti-inflammatory, and antioxidant activity, among others. Objective: To evaluate the effect of Brazilian green propolis on serum levels of inflammatory markers in hospitalized septic patients, correlating these findings with mortality, length of hospital stay, biochemical and hematological parameters, and anthropometric data. Methodology: This is a randomized, controlled, double-blind clinical trial in patients with sepsis. The treatment group (n = 25) received 1500 mg of green propolis (500 mg capsules, 3 times daily), and the control group (n = 25) received a placebo at a similar dosage and frequency for 10 days, while maintaining the standard institutional treatment for sepsis in both groups. Blood samples were collected on days 1, 5, and 10 of the study for biological analysis. Results: No statistically significant differences were found between the two groups in terms of gender (p=0.569), age (p=0.333), weight (p=0.678), height (p=0.873), and body mass index (BMI) (p=0.588). The mean age of the patients was 57.2 ± 20.6 years, and 56% of the participants were male. The length of hospital stay (p=0.515) and the clinical outcome of mortality versus hospital discharge (p=0.103) did not differ statistically between the groups. An overall mortality rate of 26% was observed among patients diagnosed with sepsis. This mortality rate is below the average for the Southeast region (51.3%) and below the national average (~55%). Regarding IL-8, IL-17A, and CXCL-16 levels, no statistically significant difference was detected between the groups at any of the time points analyzed. However, on the tenth day of treatment, there was a significant increase (p<0.05) in IL-33 levels in the propolis group compared to the control group. Discussion: In this clinical trial, IL-33 levels were higher in the group treated with propolis, which may be associated with a protective effect. It can be inferred that the mechanism of interaction between propolis and IL-33, observed on the tenth day of treatment, was statistically significant. This mechanism contributed to the activation of immune system cells, with propolis promoting and modulating the inflammatory response. Furthermore, the suppression of bacterial activity was evident, indicating the therapeutic potential of propolis. Conclusion: The inclusion of green propolis as an additional therapeutic option will certainly represent a significant advance, offering a valuable alternative to improve the prognosis of patients with sepsis. However, further multicenter studies are needed to validate the effects of green propolis in sepsis

研究设计

研究类型
Interventional

入排标准

年龄范围
18Y 至 0(—)

入选标准

  • Patients aged 18 years or older; of both sexes; who were hospitalized in the intensive care unit (ICU) with a diagnosis of sepsis of any etiology according to the criteria defined by the fifth update of the Survivor Sepsis Campaign guidelines, published in 2021; who were hemodynamically compensated; who agreed to participate in the study through informed consent

排除标准

  • Patients who present with hemodynamic instability during the study that makes enteral feeding unfeasible; pregnant or lactating women; allergy to propolis or bee products; occurrence of side effects due to the intervention; patients with severe renal or hepatic disorders; change in drug dosage; changes in diet or physical activity levels; consumption of other dietary supplements two months before the start of the research

研究者

相似试验