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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Enrollment
60
Patients will be instructed to take 250 mL of freshly prepared tea (1 tea spoon or 3 g of tea, pour over 250 mL of boiling water and leave aside for 15 min) 2 times per day during 12 weeks. The first tea needs to be taken in the morning prior any meal. The second can be taken at any time during the day but with at least 4 hour difference from the first cup.
Patients will be instructed to take 250 mL of freshly prepared tea (1 tea spoon or 3 g of tea, pour over 250 mL of boiling water and leave aside for 15 min) 2 times per day during 12 weeks. The first tea needs to be taken in the morning prior any meal. The second can be taken at any time during the day but with at least 4 hour difference from the first cup.
Department of Food and Nutrition Research, Faculty of Food Technology
Osijek, Croatia
Health Centre Osijek
Osijek, Croatia
University Hospital Centre
Osijek, Croatia
Number of patients with adverse event
Adverse event (e.g. hypoglycaemia) reporting through direct contact researcher-patient.
Time frame: Starting from baseline, once per week until study completion at week 12.
Glycated Hemoglobin
Blood HbA1c (%)
Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Fasting Glucose
Blood Glucose (mmol/L)
Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
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