Safety and Efficacy of a Complex Herbal Tea Mixture in Type 2 Diabetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Number of patients with adverse event
研究概览
简要总结
Nearly 25% of the world's population relies on traditional medicinal systems but for professionals their effectiveness and even more safety are the main concern. Therefore, the aim of this preliminary study is to assess safety and effectiveness of herbal tea mixture on the control of glycaemia in Type 2 diabetics.The mixture consists of nine plants which have well-documented traditional use for the control of glycaemia.
详细描述
The study will include Type 2 Diabetics who are taking only oral hypoglycemic medications (without insulin). Their therapy has to be stable for at least 3 months prior enrollment. Besides anthropometric measures, patient's glycaemia, renal and liver function will be monitored. Safety and adverse events will be closely monitored and these are the primary outcomes of the study. The main outcome measure of the effectiveness is HbA1c (glycated hemoglobin). Patients will be given detailed instructions on how to prepare the tea and the dosing. The intervention will last 3 months and during that time patients will be asked not to change their dietary or lifestyle habits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •Croatian-speaking
- •stable therapy for at least 3 months prior enrollment
- •not taking any dietary supplements, especially herbal-based
- •not taking any other herbal medicine (as a tea or a supplement)
- •stable dietary and lifestyle patterns for at least 3 months prior enrollment
排除标准
- •type 1 diabetes
- •severe somatic disorder (oncological disease, hepatic, renal or autoimmune disease)
- •pregnancy
- •inability to fill in questionnaires in Croatian
- •cognitive impairment
- •psychiatric disorder
- •undergoing current treatment for a major medical illness such as malignancy, autoimmune or immune deficiency disorder
- •clotting disorders
- •having nutritional deficiency (e.g. iron deficiency)
- •current or history of eating disorder (anorexia, bulimia or EDNOS)
- •current use of weight loss interventions (drugs; exercise interventions)
- •regular use of dietary supplements, especially herbal-based
- •regular use of herbal medicine (as a tea or a supplement)
- •significant changes in diet or lifestyle patterns (e.g. increased physical activity) in the last 3 months prior the enrollment
结局指标
主要结局
Number of patients with adverse event
时间窗: Starting from baseline, once per week until study completion at week 12.
Adverse event (e.g. hypoglycaemia) reporting through direct contact researcher-patient.
次要结局
- Glycated Hemoglobin(At enrollment (baseline) and at the end of the intervention (at 12 weeks).)
- Fasting Glucose(At enrollment (baseline) and at the end of the intervention (at 12 weeks).)
研究者
Ines Banjari
Associate Prof. Dr.
Josip Juraj Strossmayer University of Osijek