Type 2 DiabetesDIABHerbMixNCT04054284
Safety and Efficacy of Herbal Tea in Type 2 Diabetics
A study testing Antidiabetic Herbal Tea and Herbal Tea in people with Type 2 Diabetes and Herbal Medicine Adverse Reaction, run by Josip Juraj Strossmayer University of Osijek at 3 sites in Croatia.
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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Herbal Medicine Adverse Reaction
- What is being tested?
- Antidiabetic Herbal Tea and Herbal Tea
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesCroatia
- Study dates
- 1 Jul 2019to 12 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Croatia3 sites
Department of Food and Nutrition Research, Faculty of Food Technology
Osijek, 31000
Health Centre Osijek
Osijek, 31000
University Hospital Centre
Osijek, 31000
About this study
Official title: Safety and Efficacy of a Complex Herbal Tea Mixture 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.
Read the 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.
- Conditions
- Type 2 Diabetes, Herbal Medicine Adverse Reaction
- Being tested
- Antidiabetic Herbal Tea, Herbal Tea
- Keywords
- Type 2 Diabetes, Herbal Medicine, Safety, Glycaemia Control, Alternative Therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antidiabetic Herbal TeaDietary supplement
Also called Experimental-Intervention
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 TeaDietary supplement
Also called Active Comparator-Control
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Herbal Tea Mixture is consisted of: Vaccinium myrtillus L. folium, Morus nigra L. folium, Phaseolus vulgaris L. pericarpium, Viscum album L. herba, Urtica dioica L. radix, Gentiana lutea L. radix, Taraxacum officinale W. radix, Cichorium intybus L. herba, Teucrium chamaedrys L. herba, Stevia rebaudiana folium. Receives: Dietary Supplement: Antidiabetic Herbal Tea |
| Control | Active comparator | Herbal Tea Mixture without antidiabetic properties is consisted of: Achillea millefolium L. herba, Teucrium montanum L. herba, Glechoma hederacea L. herba, Eupatorium cannabinum L. herba, Humulus lupulus L. lupulin, Artemisia absinthium L. herba, Salvia officinalis L. Receives: Dietary Supplement: Herbal Tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse event
Adverse event (e.g. hypoglycaemia) reporting through direct contact researcher-patient.
Measured: Starting from baseline, once per week until study completion at week 12.
Secondary outcomes (2)
Glycated Hemoglobin
Blood HbA1c (%)
Measured: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Fasting Glucose
Blood Glucose (mmol/L)
Measured: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Jul 2019
- Primary completion10 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Collaborators
- Dom zdravlja Osijek (Health Centre Osijek), Osijek University Hospital
- Responsible party
- Principal investigator, Ines Banjari, Josip Juraj Strossmayer University of Osijek
- Investigators
- Ines Banjari, PhD, Principal investigator, Department of Food and Nutrition Research, Faculty of Food Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054284
- Sponsor's protocol ID
- JJStrossmayerU-1
- Acronym
- DIABHerbMix
- Status last verified
- Feb 2020
- First submitted
- 29 Jul 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Complex Herbal Tea Mixture in Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT04054284
- Acronym / sponsor ID
- DIABHerbMix / JJStrossmayerU-1
- Conditions
- Type 2 Diabetes, Herbal Medicine Adverse Reaction
- Keywords
- Type 2 Diabetes, Herbal Medicine, Safety, Glycaemia Control, Alternative Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Collaborators
- Dom zdravlja Osijek (Health Centre Osijek), Osijek University Hospital
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Antidiabetic Herbal TeaHerbal Tea Mixture is consisted of: Vaccinium myrtillus L. folium, Morus nigra L. folium, Phaseolus vulgaris L. pericarpium, Viscum album L. herba, Urtica dioica L. radix, Gentiana lutea L. radix, Taraxacum officinale W. radix, Cichorium intybus L. herba, Teucrium chamaedrys L. herba, Stevia rebaudiana folium. |
| Control | Active comparator | Dietary Supplement: Herbal TeaHerbal Tea Mixture without antidiabetic properties is consisted of: Achillea millefolium L. herba, Teucrium montanum L. herba, Glechoma hederacea L. herba, Eupatorium cannabinum L. herba, Humulus lupulus L. lupulin, Artemisia absinthium L. herba, Salvia officinalis L. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- type 1 diabetes
- severe somatic disorder (oncological disease, hepatic, renal or autoimmune disease)
- pregnancy
- inability to fill in questionnaires in Croatian
- cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antidiabetic Herbal TeaAlso: Experimental-InterventionPatients 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 supplement | Intervention |
| Herbal TeaAlso: Active Comparator-ControlPatients 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 supplement | Control |
Primary outcome
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.
2 secondary outcomes
Glycated Hemoglobin
Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Fasting Glucose
Time frame: At enrollment (baseline) and at the end of the intervention (at 12 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ines Banjari, PhD principal investigator
Department of Food and Nutrition Research, Faculty of Food Technology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antidiabetic Herbal Tea and Herbal Tea in people with Type 2 Diabetes and Herbal Medicine Adverse Reaction, run by Josip Juraj Strossmayer University of Osijek at 3 sites in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse event (time frame: Starting from baseline, once per week until study completion at week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.