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

Primary Purpose

Type 2 Diabetes, Herbal Medicine Adverse Reaction

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Antidiabetic Herbal Tea
Herbal Tea
Sponsored by
Josip Juraj Strossmayer University of Osijek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Herbal Medicine, Safety, Glycaemia Control, Alternative Therapy

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of patients with adverse event
Adverse event (e.g. hypoglycaemia) reporting through direct contact researcher-patient.

Secondary Outcome Measures

Glycated Hemoglobin
Blood HbA1c (%)
Fasting Glucose
Blood Glucose (mmol/L)

Full Information

First Posted
July 29, 2019
Last Updated
February 12, 2020
Sponsor
Josip Juraj Strossmayer University of Osijek
Collaborators
Dom zdravlja Osijek (Health Centre Osijek), Osijek University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04054284
Brief Title
Safety and Efficacy of Herbal Tea in Type 2 Diabetics
Acronym
DIABHerbMix
Official Title
Safety and Efficacy of a Complex Herbal Tea Mixture in Type 2 Diabetics
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Josip Juraj Strossmayer University of Osijek
Collaborators
Dom zdravlja Osijek (Health Centre Osijek), Osijek University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Herbal Medicine Adverse Reaction
Keywords
Type 2 Diabetes, Herbal Medicine, Safety, Glycaemia Control, Alternative Therapy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Antidiabetic Herbal Tea
Other Intervention Name(s)
Experimental-Intervention
Intervention Description
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
Intervention Name(s)
Herbal Tea
Other Intervention Name(s)
Active Comparator-Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients with adverse event
Description
Adverse event (e.g. hypoglycaemia) reporting through direct contact researcher-patient.
Time Frame
Starting from baseline, once per week until study completion at week 12.
Secondary Outcome Measure Information:
Title
Glycated Hemoglobin
Description
Blood HbA1c (%)
Time Frame
At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Title
Fasting Glucose
Description
Blood Glucose (mmol/L)
Time Frame
At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Other Pre-specified Outcome Measures:
Title
Creatinine
Description
Blood concentration of Creatinine (µmol)
Time Frame
At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Title
Urea
Description
Blood concentration of Urea (mmol/L)
Time Frame
At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Title
Total Proteins
Description
Blood concentration of Total Proteins (g/L)
Time Frame
At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Title
Alanine transaminase
Description
Blood concentration of liver enzymes Alanine transaminase (ALT in U/L)
Time Frame
At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Title
Aspartate transaminase
Description
Blood concentration of liver enzymes Aspartate transaminase (AST in U/L)
Time Frame
At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Title
Alkaline phosphatase
Description
Blood concentration of liver enzymes Alkaline phosphatase (ALP in U/L)
Time Frame
At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Title
Gamma-glutamyl transpeptidase
Description
Blood concentration of liver enzymes Gamma-glutamyl transpeptidase (GGT in U/L)
Time Frame
At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Title
Body Weight
Description
Change in body weigh (in kg), Body Mass Index in kg/m2, waist circumference in cm
Time Frame
At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Title
Body Mass Index
Description
Change in Body Mass Index (kg per square meter)
Time Frame
At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Title
Waist Circumference
Description
Change in waist circumference (in cm)
Time Frame
At enrollment (baseline) and at the end of the intervention (at 12 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ines Banjari, PhD
Organizational Affiliation
Department of Food and Nutrition Research, Faculty of Food Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Food and Nutrition Research, Faculty of Food Technology
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Health Centre Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
University Hospital Centre
City
Osijek
ZIP/Postal Code
31000
Country
Croatia

12. IPD Sharing Statement

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Safety and Efficacy of Herbal Tea in Type 2 Diabetics

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