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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04339283
Other study ID # Hibiscus-tea Study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date October 30, 2019

Study information

Verified date April 2020
Source University of Ibadan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hibiscus sabdariffa tea is commonly used all over the world by healthy individual but the tea is also employed by patients in the management of chronic diseases such as hypertension diabetes, high cholesterol, liver disease etc. Several studies in humans and animal have proved the efficacy of Hibiscus sabdariffa tea in lowering blood pressure, blood glucose level and serum total cholesterol. But no study exists on the effect of daily consumption of this tea on blood pressure, blood glucose, total cholesterol and other biochemical and hematological parameters in healthy humans. Hence this study.


Description:

Several studies have been carried out on the effect of the water beverage of Hibiscus sabdariffa, most focus on hypertensive patients, diabetic patients and obese patient and some studies investigated the hypolipidemic a effect of the water beverage of Hibiscus sabdariffa as well as its effect on haematological parameters but mice were used for these studies. Little or no investigation has been done to assess the safety of daily consumption of this water beverage of hibiscus sabdariffa on humans.

Hence, this study aims at investigating the safety in the daily consumption of Zobo in humans, monitoring lipid profile, blood pressure, blood glucose, body mass index and haematological parameters such as haematocrit, haemoglobin, total white blood cells and also hepatic indices.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date October 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy volunteers only

- Not on any medications or herbs

- No disease condition

- Females not pregnant

- Non-smokers

Exclusion Criteria:

- Below 18yrs or above 40 years

- presence of chronic disease

- on medications pregnant females

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Standardized Hibiscus sabdariffa tea
Daily consumption of Standardized Hibiscus sabdariffa tea

Locations

Country Name City State
Nigeria Department of Clinical Pharmacy Laboratory, University of Ibadan Ibadan Oyo

Sponsors (1)

Lead Sponsor Collaborator
University of Ibadan

Country where clinical trial is conducted

Nigeria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Systolic Blood Pressure and Diastolic Blood Pressure on the 14th day Blood pressure was measured in mmHg at baseline and on the 14th day of study with the aid of Omron Digital Blood pressure monitor 14 days
Primary Change from Baseline Systolic Blood Pressure and Diastolic Blood Pressure on the 28th day Systolic and Diastolic Blood pressures were measured in mmHg at baseline and on the 28th day of study with the aid of Omron Digital Blood pressure monitor 28 days
Primary Change from Baseline Fasting Blood Glucose level on the 14th day Fating blood glucose level was measured with AccuChek Active glucometer in mg/dL on the 14th day of study 14 days
Primary Change from Baseline Fasting Blood Glucose level on the 28th day Fating blood glucose level was measured with AccuChek Active glucometer in mg/dL on the 28th day of study 28 days
Primary Change from Baseline Total Serum Cholesterol on the 14th day Total Serum Cholesterol was analysed with Randox kit and measured in mg/dL on the 14th day 14 days
Primary Change from Baseline Total Serum Cholesterol on the 28th day Total Serum Cholesterol was analysed with Randox kit and measured in mg/dL on the 28th day 28 days
Primary Change from Baseline Triglyceride on the 14th day Triglyceride was analysed with Randox kit and measured in mg/dL on the 14th day 14 days
Primary Change from Baseline Triglyceride on the 28th day Triglyceride was analysed with Randox kit and measured in mg/dL on the 28th day 28 days
Primary Change from Baseline High Density Lipoprotein Cholesterol on the 14th day High Density Lipoprotein Cholesterol was analysed with Randox kit and measured in mg/dL on the 14th day 14 days
Primary Change from Baseline High Density Lipoprotein Cholesterol on the 28th day High Density Lipoprotein Cholesterol was analysed with Randox kit and measured in mg/dL on the 28th day 28 days
Primary Change from Baseline Low Density Lipoprotein Cholesterol on the 14th day Low Density Lipoprotein Cholesterol was analysed with Randox kit and measured in mg/dL on the 14th day 14 days
Primary Change from Baseline Low Density Lipoprotein Cholesterol on the 28th day Low Density Lipoprotein Cholesterol was analysed with Randox kit and measured in mg/dL on the 28th day 28 days
Primary Change form Baseline Alanine Aminotransferase on the 14th day Alanine aminotransferase was analysed with Randox kit and measured in U/L on the 14th day 14 days
Primary Change form Baseline Alanine Aminotransferase on the 28th day Alanine aminotransferase was analysed with Randox kit and measured in U/L on the 28th day 28 days
Primary Change form Baseline Aspartate Aminotransferase on the 14th day Aspartate aminotransferase was analysed with Randox kit and measured in U/L on the 14th day 14 days
Primary Change form Baseline Aspartate Aminotransferase on the 28th day Aspartate aminotransferase was analysed with Randox kit and measured in U/L on the 28th day 28 days
Primary Change form Baseline Blood Urea Nitrogen on the 14th day Blood Urea Nitrogen was analysed with Randox kit and measured in mg/dL on the 14th day 14 days
Primary Change form Baseline Blood Urea Nitrogen on the 28th day Blood Urea Nitrogen was analysed with Randox kit and measured in mg/dL on the 28th day 28 days
Primary Change form Baseline Serum Creatinine on the 14th day Serum Creatinine was analysed with Randox kit and measured in mg/dL on the 14th day 14 days
Primary Change form Baseline Serum Creatinine on the 28th day Serum Creatinine was analysed with Randox kit and measured in mg/dL on the 28th day 28 days
Primary Change form Baseline Albumin on the 14th day Albumin was analysed with Randox kit and measured in g/dL on the 14th day 14 days
Primary Change form Baseline Albumin on the 28th day Albumin was analysed with Randox kit and measured in g/dL on the 28th day 28 days
Primary Change form Baseline Hematocrit on the 14th day Hematocrit was analysed in the laboratory and measured in % on the 14th day 14 days
Primary Change form Baseline Hematocrit on the 28th day Hematocrit was analysed in the laboratory and measured in % on the 28th day 28 days
Primary Change form Baseline Hemoglobin on the 14th day Hemoglobin was analysed in the laboratory and measured in g/dL on the 14th day 14 days
Primary Change form Baseline Hemoglobin on the 28th day Hemoglobin was analysed in the laboratory and measured in g/dL on the 28th day 28 days
Primary Change form Baseline White Blood Cell count on the 14th day White Blood Cell counts was analysed in the laboratory and measured in 10*3/ µL on the 14th day 14 days
Primary Change form Baseline White Blood Cell count on the 28th day White Blood Cell counts was analysed in the laboratory and measured in 10*3/ µL on the 28th day 28 days
Primary Change form Baseline Total Protein on the 14th day Total Protein was analysed in the laboratory and measured in g/dL on the 14th day 14 days
Primary Change form Baseline Total Protein on the 28th day Total Protein was analysed in the laboratory and measured in g/dL on the 28th day 28 days
Primary Change form Baseline Pulse on the 14th day Pulse was measured with the BP monitor in /min on the 14th day 14 days
Primary Change form Baseline Pulse on the 28th day Pulse was measured with the BP monitor in /min on the 28th day 28 days
Secondary Change from Baseline Body Mass Index on the 14th day Body mass index measure in kg/sq m was calculated from a measure of weight in kg and height in meters on the 14 day 14 day
Secondary Change from Baseline Body Mass Index on the 28th day Body mass index measure in kg/sq m was calculated from a measure of weight in kg and height in meters on the 14 day 28 day
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