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NCT Number: NCT04054284

Safety and Efficacy of Herbal Tea 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Herbal Medicine Adverse Reaction Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Nutrition Research, Faculty of Food Technology, Osijek, Croatia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antidiabetic Herbal Tea

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.

Other names: Experimental-Intervention

Herbal Tea

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.

Other names: Active Comparator-Control

Primary outcomes

  1. 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 outcomes

  1. Glycated Hemoglobin

    Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).

    Blood HbA1c (%)

  2. Fasting Glucose

    Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).

    Blood Glucose (mmol/L)

Other outcomes

  1. Creatinine

    Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).

    Blood concentration of Creatinine (µmol)

  2. Urea

    Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).

    Blood concentration of Urea (mmol/L)

  3. Total Proteins

    Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).

    Blood concentration of Total Proteins (g/L)

  4. Alanine transaminase

    Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).

    Blood concentration of liver enzymes Alanine transaminase (ALT in U/L)

  5. Aspartate transaminase

    Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).

    Blood concentration of liver enzymes Aspartate transaminase (AST in U/L)

  6. Alkaline phosphatase

    Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).

    Blood concentration of liver enzymes Alkaline phosphatase (ALP in U/L)

  7. Gamma-glutamyl transpeptidase

    Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).

    Blood concentration of liver enzymes Gamma-glutamyl transpeptidase (GGT in U/L)

  8. Body Weight

    Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).

    Change in body weigh (in kg), Body Mass Index in kg/m2, waist circumference in cm

  9. Body Mass Index

    Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).

    Change in Body Mass Index (kg per square meter)

  10. Waist Circumference

    Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).

    Change in waist circumference (in cm)

Sponsors and collaborators

Lead sponsor

Josip Juraj Strossmayer University of Osijek

Other

Collaborators

  • Dom zdravlja Osijek (Health Centre Osijek)
  • Osijek University Hospital

Registry information

Official study title

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

Acronym: DIABHerbMix

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2019
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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