Clinical trial NCT04054284: Safety and Efficacy of Herbal Tea in Type 2 Diabetics
Official title: Safety and Efficacy of a Complex Herbal Tea Mixture in Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Herbal Medicine Adverse Reaction
Keywords: Type 2 Diabetes
Herbal Medicine
Safety
Glycaemia Control
Alternative Therapy
Lead sponsor: Josip Juraj Strossmayer University of Osijek
Sponsor class: OTHER
Collaborators: name: Dom zdravlja Osijek (Health Centre Osijek)
name: Osijek University Hospital
First posted: 2019-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Number of patients with adverse event
timeFrame: Starting from baseline, once per week until study completion at week 12.
Secondary outcomes:
measure: Glycated Hemoglobin
timeFrame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
measure: Fasting Glucose
timeFrame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Other outcomes:
measure: Creatinine
timeFrame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
measure: Urea
timeFrame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
measure: Total Proteins
timeFrame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
measure: Alanine transaminase
timeFrame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
measure: Aspartate transaminase
timeFrame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
measure: Alkaline phosphatase
timeFrame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
measure: Gamma-glutamyl transpeptidase
timeFrame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
measure: Body Weight
timeFrame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
measure: Body Mass Index
timeFrame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
measure: Waist Circumference
timeFrame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Locations:
city: Osijek
country: Croatia
facility: Department of Food and Nutrition Research, Faculty of Food Technology
city: Osijek
country: Croatia
facility: Health Centre Osijek
city: Osijek
country: Croatia
facility: University Hospital Centre
Study officials:
affiliation: Department of Food and Nutrition Research, Faculty of Food Technology
name: Ines Banjari, PhD
role: PRINCIPAL_INVESTIGATOR
References: