Status:

COMPLETED

Safety and Efficacy of Herbal Tea in Type 2 Diabetics

Lead Sponsor:

Josip Juraj Strossmayer University of Osijek

Collaborating Sponsors:

Dom zdravlja Osijek (Health Centre Osijek)

Osijek University Hospital

Conditions:

Type 2 Diabetes

Herbal Medicine Adverse Reaction

Eligibility:

All Genders

40-75 years

Phase:

NA

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...

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 anthropometr...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 12 2020

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT04054284

Start Date

July 1 2019

End Date

February 12 2020

Last Update

February 13 2020

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Department of Food and Nutrition Research, Faculty of Food Technology

Osijek, Croatia, 31000

2

Health Centre Osijek

Osijek, Croatia, 31000

3

University Hospital Centre

Osijek, Croatia, 31000