Safety and Efficacy of Herbal Tea in Type 2 Diabetics

NCT ID: NCT04054284

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-02-12

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.

Conditions

Type 2 Diabetes; Herbal Medicine Adverse Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Antidiabetic Herbal Tea

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: ACTIVE_COMPARATOR

Herbal Tea

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Experimental-Intervention; Active Comparator-Control

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dom zdravlja Osijek (Health Centre Osijek)

UNKNOWN

Sponsor Role: collaborator

Osijek University Hospital

OTHER

Sponsor Role: collaborator

Josip Juraj Strossmayer University of Osijek

OTHER

Sponsor Role: lead

Responsible Party

Ines Banjari

Associate Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ines Banjari, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Food and Nutrition Research, Faculty of Food Technology

Locations

Department of Food and Nutrition Research, Faculty of Food Technology

Osijek, , Croatia

Health Centre Osijek

Osijek, , Croatia

University Hospital Centre

Osijek, , Croatia

Countries

Croatia

Other Identifiers

JJStrossmayerU-1

Identifier Type: -

Identifier Source: org_study_id