Safety and Efficacy of Herbal Tea in Type 2 Diabetics (DIABHerbMix)

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Herbal Medicine Adverse Reaction
• Intervention / Treatment: Dietary supplement: Antidiabetic Herbal Tea; Dietary supplement: Herbal Tea

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Osijek, Croatia, 31000
    • Department of Food and Nutrition Research, Faculty of Food Technology
  • Osijek, Croatia, 31000
    • Health Centre Osijek
  • Osijek, Croatia, 31000
    • University Hospital Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

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).

Other Outcome Measures

Outcome Measure	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)	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).

Collaborators and Investigators

• Sponsor: Josip Juraj Strossmayer University of Osijek
• Collaborators: Osijek University Hospital; Dom zdravlja Osijek (Health Centre Osijek)

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): February 10, 2020
• Study Completion (ACTUAL): February 12, 2020

Study Registration Dates

• First Submitted: July 29, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (ACTUAL): August 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Safety; Type 2 Diabetes; Herbal Medicine; Alternative Therapy; Glycaemia Control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Hypoglycemic Agents
• Other Study ID Numbers: JJStrossmayerU-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No