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| Name | Class |
|---|---|
| Dom zdravlja Osijek (Health Centre Osijek) | UNKNOWN |
| Osijek University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Herbal Tea Mixture is consisted of: Vaccinium myrtillus L. folium, Morus nigra L. folium, Phaseolus vulgaris L. pericarpium, Viscum album L. herba, Urtica dioica L. radix, Gentiana lutea L. radix, Taraxacum officinale W. radix, Cichorium intybus L. herba, Teucrium chamaedrys L. herba, Stevia rebaudiana folium. |
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| Control | Active Comparator | Herbal Tea Mixture without antidiabetic properties is consisted of: Achillea millefolium L. herba, Teucrium montanum L. herba, Glechoma hederacea L. herba, Eupatorium cannabinum L. herba, Humulus lupulus L. lupulin, Artemisia absinthium L. herba, Salvia officinalis L. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antidiabetic Herbal Tea | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse event | Adverse event (e.g. hypoglycaemia) reporting through direct contact researcher-patient. | Starting from baseline, once per week until study completion at week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated Hemoglobin | Blood HbA1c (%) | At enrollment (baseline) and at the end of the intervention (at 12 weeks). |
| Fasting Glucose | Blood Glucose (mmol/L) |
| Measure | Description | Time Frame |
|---|---|---|
| Creatinine | Blood concentration of Creatinine (µmol) | At enrollment (baseline) and at the end of the intervention (at 12 weeks). |
| Urea | Blood concentration of Urea (mmol/L) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ines Banjari, PhD | Department of Food and Nutrition Research, Faculty of Food Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Food and Nutrition Research, Faculty of Food Technology | Osijek | 31000 | Croatia | |||
| Health Centre Osijek |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 3, 2021 | |
| Reset | Mar 29, 2021 | |
| Release | Mar 28, 2023 | |
| Reset | Jan 3, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 3, 2021 | Mar 29, 2021 | |||
| Mar 28, 2023 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069459 | Teas, Herbal |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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| Herbal Tea | Dietary Supplement | 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. |
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| At enrollment (baseline) and at the end of the intervention (at 12 weeks). |
| At enrollment (baseline) and at the end of the intervention (at 12 weeks). |
| Total Proteins | Blood concentration of Total Proteins (g/L) | At enrollment (baseline) and at the end of the intervention (at 12 weeks). |
| Alanine transaminase | Blood concentration of liver enzymes Alanine transaminase (ALT in U/L) | At enrollment (baseline) and at the end of the intervention (at 12 weeks). |
| Aspartate transaminase | Blood concentration of liver enzymes Aspartate transaminase (AST in U/L) | At enrollment (baseline) and at the end of the intervention (at 12 weeks). |
| Alkaline phosphatase | Blood concentration of liver enzymes Alkaline phosphatase (ALP in U/L) | At enrollment (baseline) and at the end of the intervention (at 12 weeks). |
| Gamma-glutamyl transpeptidase | Blood concentration of liver enzymes Gamma-glutamyl transpeptidase (GGT in U/L) | At enrollment (baseline) and at the end of the intervention (at 12 weeks). |
| Body Weight | Change in body weigh (in kg), Body Mass Index in kg/m2, waist circumference in cm | At enrollment (baseline) and at the end of the intervention (at 12 weeks). |
| Body Mass Index | Change in Body Mass Index (kg per square meter) | At enrollment (baseline) and at the end of the intervention (at 12 weeks). |
| Waist Circumference | Change in waist circumference (in cm) | At enrollment (baseline) and at the end of the intervention (at 12 weeks). |
| Osijek |
| 31000 |
| Croatia |
| University Hospital Centre | Osijek | 31000 | Croatia |
| Jan 3, 2024 |
| D004700 | Endocrine System Diseases |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |