Safety and Efficacy of Herbal Tea in Type 2 Diabetics

Type 2 Diabetes Clinical Trial

— DIABHerbMix  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04054284
• Other study ID #: JJStrossmayerU-1
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: February 12, 2020

Study information

• Verified date: February 2020
• Source: Josip Juraj Strossmayer University of Osijek
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 12, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Herbal Medicine Adverse Reaction
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Croatia	Department of Food and Nutrition Research, Faculty of Food Technology	Osijek
Croatia	Health Centre Osijek	Osijek
Croatia	University Hospital Centre	Osijek

Sponsors (3)

Lead Sponsor	Collaborator
Josip Juraj Strossmayer University of Osijek	Dom zdravlja Osijek (Health Centre Osijek), Osijek University Hospital

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Creatinine	Blood concentration of Creatinine (µmol)	At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Other	Urea	Blood concentration of Urea (mmol/L)	At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Other	Total Proteins	Blood concentration of Total Proteins (g/L)	At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Other	Alanine transaminase	Blood concentration of liver enzymes Alanine transaminase (ALT in U/L)	At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Other	Aspartate transaminase	Blood concentration of liver enzymes Aspartate transaminase (AST in U/L)	At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Other	Alkaline phosphatase	Blood concentration of liver enzymes Alkaline phosphatase (ALP in U/L)	At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Other	Gamma-glutamyl transpeptidase	Blood concentration of liver enzymes Gamma-glutamyl transpeptidase (GGT in U/L)	At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Other	Body Weight	Change in body weigh (in kg), Body Mass Index in kg/m2, waist circumference in cm	At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Other	Body Mass Index	Change in Body Mass Index (kg per square meter)	At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Other	Waist Circumference	Change in waist circumference (in cm)	At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Primary	Number of patients with adverse event	Adverse event (e.g. hypoglycaemia) reporting through direct contact researcher-patient.	Starting from baseline, once per week until study completion at week 12.
Secondary	Glycated Hemoglobin	Blood HbA1c (%)	At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Secondary	Fasting Glucose	Blood Glucose (mmol/L)	At enrollment (baseline) and at the end of the intervention (at 12 weeks).