Effect of Standardized Hibiscus Sabdariffa Tea in Seemingly Healthy Human Volunteers
Standardized Hibiscus Sabdariffa Linn Tea, Potential Nutraceutical Candidate for the Prevention of Hypertension, Diabetes, and Hypercholesterolemia - a Pilot Study
1 other identifier
interventional
32
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedFirst Submitted
Initial submission to the registry
March 31, 2020
CompletedFirst Posted
Study publicly available on registry
April 9, 2020
CompletedApril 9, 2020
April 1, 2020
29 days
March 31, 2020
April 5, 2020
Conditions
Outcome Measures
Primary Outcomes (32)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Change form Baseline Hematocrit on the 14th day
Hematocrit was analysed in the laboratory and measured in % on the 14th day
14 days
Change form Baseline Hematocrit on the 28th day
Hematocrit was analysed in the laboratory and measured in % on the 28th day
28 days
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
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
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
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
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
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
Change form Baseline Pulse on the 14th day
Pulse was measured with the BP monitor in /min on the 14th day
14 days
Change form Baseline Pulse on the 28th day
Pulse was measured with the BP monitor in /min on the 28th day
28 days
Secondary Outcomes (2)
Change from Baseline Body Mass Index on the 14th day
14 day
Change from Baseline Body Mass Index on the 28th day
28 day
Study Arms (2)
Standardized Hibiscus sabdariffa tea Arm
EXPERIMENTAL300 mL of freshly prepared standardized Hibiscus sabdariffa tea (containing 102.49 mg/L of total monomeric anthocyanin) is administered daily to the participants for 28 days
Water Arm
NO INTERVENTION300 mL of distilled water is administered to the participants daily for 28 days.
Interventions
Daily consumption of Standardized Hibiscus sabdariffa tea
Eligibility Criteria
You may qualify if:
- Healthy volunteers only
- Not on any medications or herbs
- No disease condition
- Females not pregnant
- Non-smokers
You may not qualify if:
- Below 18yrs or above 40 years
- presence of chronic disease
- on medications pregnant females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Clinical Pharmacy Laboratory, University of Ibadan
Ibadan, Oyo State, 200284, Nigeria
Related Publications (1)
Pattanittum P, Ngamjarus C, Buttramee F, Somboonporn C. Roselle for hypertension in adults. Cochrane Database Syst Rev. 2021 Nov 27;11(11):CD007894. doi: 10.1002/14651858.CD007894.pub3.
PMID: 34837382DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Segun J Showande, Ph.D
University of Ibadan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
March 31, 2020
First Posted
April 9, 2020
Study Start
September 1, 2019
Primary Completion
September 30, 2019
Study Completion
October 30, 2019
Last Updated
April 9, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share