Safety and Efficacy of Herbal Tea in Type 2 Diabetics

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Safety and Efficacy of a Complex Herbal Tea Mixture in Type 2 Diabetics

Conditions
-----------------
Type 2 Diabetes, Herbal Medicine Adverse Reaction

Intervention / Treatment
-----------------
* Dietary Supplement: Antidiabetic Herbal Tea
* Dietary Supplement: Herbal Tea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Dietary Supplement: Antidiabetic Herbal Tea<br>* 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.<br>* Other names: Experimental-Intervention;|
| Active Comparator: Control<br>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. | Dietary Supplement: Herbal Tea<br>* 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.<br>* Other names: Active Comparator-Control;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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) | At enrollment (baseline) and at the end of the intervention (at 12 weeks). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes, Herbal Medicine, Safety, Glycaemia Control, Alternative Therapy