Clinical Trials Directory

Trials / Completed

CompletedNCT04254016

Short Term Effects of a Hibiscus Sabdariffa and Stevia Rebaudiana Drink on Cardiac Relaxation and Urinary Albumin Excretion in a Group of Diabetic Type 2 Subjects

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
22 (actual)
Sponsor
Yaounde Central Hospital · Other Government
Sex
All
Age
21 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The aim of this study is to evaluate the effects of a Hibiscus Sabdariffa and Stevia Rebaudiana drink on cardiac relaxation and urinary albumin excretion in a group of diabetic type II patients.

Detailed description

The investigators performed a non-randomized single-arm clinical trial with a before and after design, carried out from November 2016 and May 2017. Intervention consisted of the administration of a Hibiscus-Stevia drink at a dose of 4 mg / kg / day for Stevia and 4 g / day for Hibiscus for a period of 8 weeks. Before and after intervention, the following were done by the participants: bioelectrical impedance analysis (BIA), blood pressure measurements, fasting blood sugar, HbA1c, lipid profiles, liver function tests, kidney function tests, urinary excretion of albumin tests and full blood counts. These were followed by morphological workup including Electrocardiograms (ECGs), transthoracic heart ultrasounds and Ambulatory Blood Pressure Measurements (ABPM), also done before and after intervention. Clinical evaluation with fasting blood sugar control, blood pressure controls and urinary excretion albumin tests were done at the 30th and 60th days for safety purposes.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTHIBISTEVER1During 8 weeks, administration of a Hibiscus-Stevia drink for 8 weeks at a dose of 4 mg / kg / day for Stevia and 4 g / day for Hibiscus. Evaluation will take place the 30th and 60th days.

Timeline

Start date
2016-11-01
Primary completion
2017-05-01
Completion
2017-05-01
First posted
2020-02-05
Last updated
2020-02-05

Locations

1 site across 1 country: Cameroon

Source: ClinicalTrials.gov record NCT04254016. Inclusion in this directory is not an endorsement.