NCT03804801|UnknownPhase 4FDA Drug
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Sponsor study identifier
interventional
40
0 countries
N/A
Study Start
February 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 29, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Hypertension, also known as high blood pressure, is a very common disease and is considered "the silent killer". Hypertension is responsible for at least 45% of deaths due to heart disease, and 51% of deaths due to stroke. Hypertension plays a part in the worry of heart disease, stroke and kidney failure and premature mortality and disability. If hypertension goes uncontrolled, in the long term, it will cause serious complications, most of which will necessitate costly interventions to be solved and managed. Apparently, these interventions may include cardiac bypass surgery, carotid artery surgery and dialysis, draining individual and government budgets. Recent studies show that hibiscus (Hibiscus sabdariffa) tea can lower blood pressure as effectively as some standard anti-hypertensive drugs can. Hibiscus is widely consumed around the world as a ruby-colored, lemony beverage. Hibiscus is safe and, unlike most blood pressure drugs, rarely causes side effects. All of the studies the investigators found in the literature were either underpowered or inconclusive. All of these studies recommended further studies with bigger samples to accurately assess the effect of hibiscus sabdariffa on blood pressure in hypertensive patients. The aim of this study is to assess the feasibility of a large-scale study assessing the effectiveness of Hibiscus sabdariffa on lowering blood pressure in individuals with elevated blood pressure.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 29, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 7, 2019
Actual (reported)January 15, 2019
Actual (reported)February 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 29, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Blood Pressure (BP)
The investigators want to see the effect of Hibiscus Sabdariffa on the blood pressure of participants in the intervention group.
3 months
Low-density lipoprotein (LDL) levels
3 months
The Pittsburgh Sleep Quality Index (PSQI)
3 months
The Depression, Anxiety, and Stress Scales (DASS)
3 months
The Perceived Stress Scale (PSS)
3 months
This arm will receive the intervention (Hibiscus Sabdariffa extract supplement)
This arm will receive no intervention whatsoever, not even placebo
The extract of the plant Hibiscus Sabdariffa, also known as sour or red tea
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Al-Shafei AI, El-Gendy OA. Effects of Roselle on arterial pulse pressure and left ventricular hypertrophy in hypertensive patients. Saudi Med J. 2013 Dec;34(12):1248-54.
Nwachukwu DC, Aneke EI, Obika LF, Nwachukwu NZ. Effects of aqueous extract of Hibiscus sabdariffa on the renin-angiotensin-aldosterone system of Nigerians with mild to moderate essential hypertension: A comparative study with lisinopril. Indian J Pharmacol. 2015 Sep-Oct;47(5):540-5. doi: 10.4103/0253-7613.165194.
First Submitted
January 7, 2019
First Posted
January 15, 2019
Study Start
February 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Effect of Oat Beta Glucan in Managing Blood Pressure
Contact the study team to confirm eligibility.
Nwachukwu DC, Aneke E, Nwachukwu NZ, Obika LF, Nwagha UI, Eze AA. Effect of Hibiscus sabdariffaon blood pressure and electrolyte profile of mild to moderate hypertensive Nigerians: A comparative study with hydrochlorothiazide. Niger J Clin Pract. 2015 Nov-Dec;18(6):762-70. doi: 10.4103/1119-3077.163278.
Herrera-Arellano A, Miranda-Sanchez J, Avila-Castro P, Herrera-Alvarez S, Jimenez-Ferrer JE, Zamilpa A, Roman-Ramos R, Ponce-Monter H, Tortoriello J. Clinical effects produced by a standardized herbal medicinal product of Hibiscus sabdariffa on patients with hypertension. A randomized, double-blind, lisinopril-controlled clinical trial. Planta Med. 2007 Jan;73(1):6-12. doi: 10.1055/s-2006-957065.
Herrera-Arellano A, Flores-Romero S, Chavez-Soto MA, Tortoriello J. Effectiveness and tolerability of a standardized extract from Hibiscus sabdariffa in patients with mild to moderate hypertension: a controlled and randomized clinical trial. Phytomedicine. 2004 Jul;11(5):375-82. doi: 10.1016/j.phymed.2004.04.001.
Gurrola-Diaz CM, Garcia-Lopez PM, Sanchez-Enriquez S, Troyo-Sanroman R, Andrade-Gonzalez I, Gomez-Leyva JF. Effects of Hibiscus sabdariffa extract powder and preventive treatment (diet) on the lipid profiles of patients with metabolic syndrome (MeSy). Phytomedicine. 2010 Jun;17(7):500-5. doi: 10.1016/j.phymed.2009.10.014. Epub 2009 Dec 3.
Serban C, Sahebkar A, Ursoniu S, Andrica F, Banach M. Effect of sour tea (Hibiscus sabdariffa L.) on arterial hypertension: a systematic review and meta-analysis of randomized controlled trials. J Hypertens. 2015 Jun;33(6):1119-27. doi: 10.1097/HJH.0000000000000585.
Wahabi HA, Alansary LA, Al-Sabban AH, Glasziuo P. The effectiveness of Hibiscus sabdariffa in the treatment of hypertension: a systematic review. Phytomedicine. 2010 Feb;17(2):83-6. doi: 10.1016/j.phymed.2009.09.002. Epub 2009 Oct 3.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Primary Completion
April 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 29, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 16, 2019
Record last verified: 2019-01
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