Safety and Efficacy of Herbal Tea in Type 2 Diabetics

NCT04054284 | Completed

• 1 other identifier: JJStrossmayerU-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Type 2 Diabetes; Herbal Medicine Adverse Reaction

Keywords

Type 2 Diabetes; Herbal Medicine; Safety; Glycaemia Control; Alternative Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Glycated Hemoglobin

  At enrollment (baseline) and at the end of the intervention (at 12 weeks).

• Fasting Glucose

  At enrollment (baseline) and at the end of the intervention (at 12 weeks).

Other Outcomes (10)

• Creatinine

  At enrollment (baseline) and at the end of the intervention (at 12 weeks).

• Urea

  At enrollment (baseline) and at the end of the intervention (at 12 weeks).

• Total Proteins

  At enrollment (baseline) and at the end of the intervention (at 12 weeks).

Study Arms (2)

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.

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.

Dietary Supplement: Herbal Tea

Interventions

Antidiabetic Herbal Tea DIETARY_SUPPLEMENT

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.

Also known as: Experimental-Intervention

Intervention

Herbal Tea DIETARY_SUPPLEMENT

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.

Also known as: Active Comparator-Control

Control

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Josip Juraj Strossmayer University of Osijek: lead
• Dom zdravlja Osijek (Health Centre Osijek): collaborator
• Osijek University Hospital: collaborator

Study Sites (3)

Department of Food and Nutrition Research, Faculty of Food Technology

Osijek, 31000, Croatia

Location

Health Centre Osijek

Osijek, 31000, Croatia

Location

University Hospital Centre

Osijek, 31000, Croatia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Teas, Herbal

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ines Banjari, PhD

  Department of Food and Nutrition Research, Faculty of Food Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof. Dr.

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 13, 2019
• Study Start: July 1, 2019
• Primary Completion: February 10, 2020
• Study Completion: February 12, 2020
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

CR (3)