Safety and Efficacy of Herbal Tea in Type 2 Diabetics

Overview

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.

Full Title of Study: “Safety and Efficacy of a Complex Herbal Tea Mixture in Type 2 Diabetics”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 10, 2020

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Josip Juraj Strossmayer University of Osijek
  • Collaborator
    • Dom zdravlja Osijek (Health Centre Osijek)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ines Banjari, Associate Prof. Dr. – Josip Juraj Strossmayer University of Osijek
  • Overall Official(s)
    • Ines Banjari, PhD, Principal Investigator, Department of Food and Nutrition Research, Faculty of Food Technology

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