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临床试验/RBR-3qfbw73
RBR-3qfbw73招募中未知

A phase II,randomized, double-blind, placebo-controlled clinical study to evaluate the effectiveness, safety and tolerability of the Extract of the Pericarp of Passiflora edulis in the glycemic control of type 1 Diabetes Mellitus

niversidade Federal do Rio Grande do Norte0 个研究点开始时间: 2023年2月2日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Intervention

入排标准

年龄范围
18Y 至 60Y(—)

入选标准

  • Both sexes aged between 18 and 60 years; type 1 diabetes mellitus diagnosis at least two years ago; absence of C-peptide; glycated hemoglobin between 7% and 10%; patients without significant changes in insulin dose (<10% of the number of daily units) in the last eight weeks; agreeing to participate in the trial by signing the informed consent form

排除标准

  • Illiterate; pregnant or breastfeeding; inability to follow research protocol; hypothyroidism; hyperthyroidism; Alzheimer's; Parkinson's; Schizophrenia; renal insufficiency; anemia; obesity (BMI> 30 kg /m2); hemoglobinopathy; acute liver disease; chronic liver disease; unit of alcohol per week: > 21 men and > 10 women; consumption of 1 or more cigarettes per day; phytotherapy; non-steroidal anti-inflammatory drugs, opiates and corticosteroids; juices or other foods based on passion fruit (P. edulis); food supplements containing passion fruit (P. edulis) in the composition

研究者

发起方
niversidade Federal do Rio Grande do Norte

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