DIABHerbMix: Safety and Efficacy of Herbal Tea in Type 2 Diabetics

Sponsor

Josip Juraj Strossmayer University of Osijek (Other)

Overall Status

Completed

CT.gov ID

NCT04054284

Collaborator

Dom zdravlja Osijek (Health Centre Osijek) (Other), Osijek University Hospital (Other)

Enrollment

Locations

Arms

7.4

Actual Duration (Months)

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Herbal Medicine Adverse Reaction	Dietary Supplement: Antidiabetic Herbal Tea Dietary Supplement: Herbal Tea	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jul 1, 2019

Actual Primary Completion Date :

Feb 10, 2020

Actual Study Completion Date :

Feb 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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 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. Other Names: Experimental-Intervention
Active Comparator: Control 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 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. Other Names: Active Comparator-Control

Arm

Intervention/Treatment

Experimental: Intervention

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

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.

Other Names:

Experimental-Intervention

Active Comparator: Control

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

Other Names:

Active Comparator-Control

Outcome Measures

Primary Outcome Measures

Number of patients with adverse event [Starting from baseline, once per week until study completion at week 12.]
Adverse event (e.g. hypoglycaemia) reporting through direct contact researcher-patient.

Secondary Outcome Measures

Glycated Hemoglobin [At enrollment (baseline) and at the end of the intervention (at 12 weeks).]
Blood HbA1c (%)
Fasting Glucose [At enrollment (baseline) and at the end of the intervention (at 12 weeks).]
Blood Glucose (mmol/L)

Other Outcome Measures

Creatinine [At enrollment (baseline) and at the end of the intervention (at 12 weeks).]
Blood concentration of Creatinine (µmol)
Urea [At enrollment (baseline) and at the end of the intervention (at 12 weeks).]
Blood concentration of Urea (mmol/L)
Total Proteins [At enrollment (baseline) and at the end of the intervention (at 12 weeks).]
Blood concentration of Total Proteins (g/L)
Alanine transaminase [At enrollment (baseline) and at the end of the intervention (at 12 weeks).]
Blood concentration of liver enzymes Alanine transaminase (ALT in U/L)
Aspartate transaminase [At enrollment (baseline) and at the end of the intervention (at 12 weeks).]
Blood concentration of liver enzymes Aspartate transaminase (AST in U/L)
Alkaline phosphatase [At enrollment (baseline) and at the end of the intervention (at 12 weeks).]
Blood concentration of liver enzymes Alkaline phosphatase (ALP in U/L)
Gamma-glutamyl transpeptidase [At enrollment (baseline) and at the end of the intervention (at 12 weeks).]
Blood concentration of liver enzymes Gamma-glutamyl transpeptidase (GGT in U/L)
Body Weight [At enrollment (baseline) and at the end of the intervention (at 12 weeks).]
Change in body weigh (in kg), Body Mass Index in kg/m2, waist circumference in cm
Body Mass Index [At enrollment (baseline) and at the end of the intervention (at 12 weeks).]
Change in Body Mass Index (kg per square meter)
Waist Circumference [At enrollment (baseline) and at the end of the intervention (at 12 weeks).]
Change in waist circumference (in cm)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Food and Nutrition Research, Faculty of Food Technology	Osijek	Croatia	31000
2	Health Centre Osijek	Osijek	Croatia	31000
3	University Hospital Centre	Osijek	Croatia	31000