Type 2 Diabetes, Herbal Medicine Adverse Reaction
Conditions
Keywords
Type 2 Diabetes, Herbal Medicine, Safety, Glycaemia Control, Alternative Therapy
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.
Interventions
DIETARY_SUPPLEMENTAntidiabetic 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.
DIETARY_SUPPLEMENTHerbal 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.
Sponsors
Dom zdravlja Osijek (Health Centre Osijek)
Osijek University Hospital
Josip Juraj Strossmayer University of Osijek
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse event | Starting from baseline, once per week until study completion at week 12. | Adverse event (e.g. hypoglycaemia) reporting through direct contact researcher-patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Hemoglobin | At enrollment (baseline) and at the end of the intervention (at 12 weeks). | Blood HbA1c (%) |
| Fasting Glucose | At enrollment (baseline) and at the end of the intervention (at 12 weeks). | Blood Glucose (mmol/L) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Alanine transaminase | At enrollment (baseline) and at the end of the intervention (at 12 weeks). | Blood concentration of liver enzymes Alanine transaminase (ALT in U/L) |
| Aspartate transaminase | At enrollment (baseline) and at the end of the intervention (at 12 weeks). | Blood concentration of liver enzymes Aspartate transaminase (AST in U/L) |
| Alkaline phosphatase | At enrollment (baseline) and at the end of the intervention (at 12 weeks). | Blood concentration of liver enzymes Alkaline phosphatase (ALP in U/L) |
| Creatinine | At enrollment (baseline) and at the end of the intervention (at 12 weeks). | Blood concentration of Creatinine (µmol) |
| Body Weight | 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 |
| Body Mass Index | At enrollment (baseline) and at the end of the intervention (at 12 weeks). | Change in Body Mass Index (kg per square meter) |
| Waist Circumference | At enrollment (baseline) and at the end of the intervention (at 12 weeks). | Change in waist circumference (in cm) |
| Gamma-glutamyl transpeptidase | 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) |
| Urea | At enrollment (baseline) and at the end of the intervention (at 12 weeks). | Blood concentration of Urea (mmol/L) |
| Total Proteins | At enrollment (baseline) and at the end of the intervention (at 12 weeks). | Blood concentration of Total Proteins (g/L) |
Countries
Croatia
Outcome results
None listed