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. 2021 Nov 27;2021(11):CD007894. doi: 10.1002/14651858.CD007894.pub3

NCT04339283.

Methods RCT (open‐label)
Participants Inclusion criteria:

  • Adults 18 to 40 years old

  • Healthy volunteers only

  • Not on any medications or herbs

  • No disease condition

  • Females not pregnant

  • Non‐smokers


Exclusion criteria:

  • Below 18 or above 40 years of age

  • Presence of chronic disease

  • On medications

  • Pregnant females
Interventions Intervention:
Standardised Hibiscus sabdariffa tea: 300 mL of freshly prepared standardised Hibiscus sabdariffa tea (containing 102.49 mg/L of total monomeric anthocyanin) is administered daily to participants for 28 days.
Control:
No intervention: water 300 mL of distilled water is administered to participants daily for 28 days.
Outcomes Primary outcomes:

  • Change from baseline systolic blood pressure and diastolic blood pressure on the 14th day (Time Frame: 14 days)

  • Change from baseline systolic blood pressure and diastolic blood pressure on the 28th day (Time Frame: 28 days)

  • Change from baseline fasting blood glucose level on the 14th day (Time Frame: 14 days)

  • Change from baseline fasting blood glucose level on the 28th day (Time Frame: 28 days)

  • Change from baseline total serum cholesterol on the 14th day (Time Frame: 14 days)

  • Change from baseline total serum cholesterol on the 28th day (Time Frame: 28 days)

  • Change from baseline triglyceride on the 14th day (Time Frame: 14 days)

  • Change from baseline triglyceride on the 28th day (Time Frame: 28 days)

  • Change from baseline high‐density lipoprotein cholesterol on the 14th day (Time Frame: 14 days)

  • Change from baseline high‐density lipoprotein cholesterol on the 28th day (Time Frame: 28 days)

  • Change from baseline low‐density lipoprotein cholesterol on the 14th day (Time Frame: 14 days)

  • Change from baseline low‐density lipoprotein cholesterol on the 28th day (Time Frame: 28 days)

  • Change from baseline alanine aminotransferase on the 14th day (Time Frame: 14 days)

  • Change from baseline alanine aminotransferase on the 28th day (Time Frame: 28 days)

  • Change from baseline aspartate aminotransferase on the 14th day (Time Frame: 14 days)

  • Change from baseline aspartate aminotransferase on the 28th day (Time Frame: 28 days)

  • Change from baseline blood urea nitrogen on the 14th day (Time Frame: 14 days)

  • Change from baseline blood urea nitrogen on the 28th day (Time Frame: 28 days)

  • Change from baseline serum creatinine on the 14th day (Time Frame: 14 days)

  • Change from baseline serum creatinine on the 28th day (Time Frame: 28 days)

  • Change from baseline albumin on the 14th day (Time Frame: 14 days)

  • Change from baseline albumin on the 28th day (Time Frame: 28 days)

  • Change from baseline haematocrit on the 14th day (Time Frame: 14 days)

  • Change from baseline haematocrit on the 28th day (Time Frame: 28 days)

  • Change from baseline haemoglobin on the 14th day (Time Frame: 14 days)

  • Change from baseline haemoglobin on the 28th day (Time Frame: 28 days)

  • Change from baseline white blood cell count on the 14th day (Time Frame: 14 days)

  • Change from baseline white blood cell count on the 28th day (Time Frame: 28 days)

  • Change from baseline total protein on the 14th day (Time Frame: 14 days)

  • Change from baseline total protein on the 28th day (Time Frame: 28 days)

  • Change from baseline pulse on the 14th day (Time Frame: 14 days)

  • Change from baseline pulse on the 28th day (Time Frame: 28 days)


Secondary outcomes:

  • Change from baseline body mass index on the 14th day (Time Frame: 14 day)

  • Change from baseline body mass index on the 28th day (Time Frame: 28 day)
Notes Source: clinicaltrials.gov/ct2/show/NCT04339283
Locations: Nigeria, Department of Clinical Pharmacy Laboratory, University of Ibadan Ibadan, Oyo, Nigeria, 200284
Sponsors and Collaborators: University of Ibadan
Principal Investigator: Segun J Showande, PhD, University of Ibadan
ClinicalTrials.gov Identifier: NCT04339283
Other Study ID Numbers: Hibiscus‐tea Study
First Posted: 9 April 2020
Last Update Posted: 9 April 2020
Last Verified: April 2020
Trial authors contacted for additional data: Yes (Date: 2 October 2020)
Reply received: 2 October 2020. This study is currently under consideration for publication.

BMI: body mass index
DBP: diastolic blood pressure
HS: Hibiscus sabdariffa
SBP: systolic blood pressure