Safety and Efficacy of Herbal Tea in Type 2 Diabetics

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Herbal Medicine Adverse Reaction
• Interventions: Dietary Supplement: Herbal Tea; Dietary Supplement: Antidiabetic Herbal Tea

• Registration Number: NCT04054284
• Lead Sponsor: Josip Juraj Strossmayer University of Osijek

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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-13
• Status Verified: 2020-02
• Primary Completion: 2020-02-10
• Study Completion: 2020-02-12
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Herbal Tea	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.
Intervention	Antidiabetic Herbal Tea	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (3)

Department of Food and Nutrition Research, Faculty of Food Technology; 🇭🇷 Osijek, Croatia

University Hospital Centre; 🇭🇷 Osijek, Croatia

Health Centre Osijek; 🇭🇷 Osijek, Croatia