Effect of Hibiscus Sabdariffa on Blood Pressure in a University Population

NCT03804801 | Unknown Phase 4 FDA Drug

• 1 other identifier: SulimanAC-Hibiscus
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Elevated Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (2)

Intervention Arm (or Group)

EXPERIMENTAL

This arm will receive the intervention (Hibiscus Sabdariffa extract supplement)

Dietary Supplement: Hibiscus Sabdariffa

Control Arm (or Group)

NO INTERVENTION

This arm will receive no intervention whatsoever, not even placebo

Interventions

Hibiscus Sabdariffa DIETARY_SUPPLEMENT

The extract of the plant Hibiscus Sabdariffa, also known as sour or red tea

Intervention Arm (or Group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both sexes
• Age 18 - 70 years
• Abnormal blood pressure (SBP 120 - 139 mm Hg; DBP 80 - 89 mm Hg)
• Sulaiman Al Rajhi Colleges affiliate (student, teaching staff member, administrative staff member, worker)
• No regular medication

You may not qualify if:

• Allergic to hibiscus sabdariffa
• Normal blood pressure (SBP ≤ 120 mm Hg; DBP ≤ 80 mm Hg)
• Essential hypertension Stage II or higher (SBP ≥ 140 mm Hg; DBP ≥ 90 mm Hg)
• Hypertension due to secondary causes
• Other comorbid conditions (diabetes mellitus, renal failure, coronary artery disease, heart failure, malignant hypertension \[BP ≥ 180/110\], etc.)
• Regular hibiscus user
• Pregnancy
• Any metabolic or malabsorptive disease that may interfere with absorption of hibiscus sabdariffa (e.g. coeliac disease, chronic pancreatitis, etc.)
• Diagnosis of a sleep disorder or use of medication that interferes with sleep (either causing drowsiness or wakefulness)
• Diagnosis of a mood disorder or stress disorder
• Taking psychiatric medication (mood stabilizers, antidepressants, anxiolytics, or antipsychotics)

Sponsors & Collaborators

• Sulaiman AlRajhi Colleges: lead

Related Publications (9)

• 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.

  PMID: 24343464 BACKGROUND

• 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.

  PMID: 26600645 BACKGROUND

• 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.

  PMID: 26289514 BACKGROUND

• 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.

  PMID: 17315307 BACKGROUND

• 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.

  PMID: 15330492 BACKGROUND

• 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.

  PMID: 19962289 BACKGROUND

• 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.

  PMID: 25875025 BACKGROUND

• 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.

  PMID: 19801187 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

Related Links

• Ogden Publications, Inc., \& Ogden Publications, Inc. (n.d.). Lower Blood Pressure Naturally With Hibiscus Tea
• Hibiscus: Uses, Side Effects, Interactions, Dosage, and Warning
• Hypertension Highlights 2017 - American Heart Association
• Psychology Foundation of Australia - Overview of Depression, Anxiety, \& Stress Scales (DASS)
• Depression, Anxiety, and Stress Scales (DASS) Questionnaire

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study participants will be randomized into 2 groups, one of which will receive the intervention and the other will not receive the intervention

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 15, 2019
• Study Start: February 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: June 29, 2019
• Last Updated: January 16, 2019

Record last verified: 2019-01