Type 2 Diabetes Clinical Trial
— DIABHerbMixOfficial title:
Safety and Efficacy of a Complex Herbal Tea Mixture in Type 2 Diabetics
Verified date | February 2020 |
Source | Josip Juraj Strossmayer University of Osijek |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Josip Juraj Strossmayer University of Osijek | Dom zdravlja Osijek (Health Centre Osijek), Osijek University Hospital |
Croatia,
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). |
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