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Effect of Hibiscus Sabdariffa on Blood Pressure in a University Population

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ClinicalTrials.gov Identifier: NCT03804801
Recruitment Status : Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Sulaiman AlRajhi Colleges

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.

Condition or disease Intervention/treatment Phase
Elevated Blood Pressure Dietary Supplement: Hibiscus Sabdariffa Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study participants will be randomized into 2 groups, one of which will receive the intervention and the other will not receive the intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Hibiscus Sabdariffa on Blood Pressure in a University Population
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : June 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Arm (or Group)
This arm will receive the intervention (Hibiscus Sabdariffa extract supplement)
Dietary Supplement: Hibiscus Sabdariffa
The extract of the plant Hibiscus Sabdariffa, also known as sour or red tea

No Intervention: Control Arm (or Group)
This arm will receive no intervention whatsoever, not even placebo



Primary Outcome Measures :
  1. Blood Pressure (BP) [ Time Frame: 3 months ]
    The investigators want to see the effect of Hibiscus Sabdariffa on the blood pressure of participants in the intervention group.


Secondary Outcome Measures :
  1. Low-density lipoprotein (LDL) levels [ Time Frame: 3 months ]
    The investigators want to see the effect of Hibiscus Sabdariffa on the low-density lipoprotein (LDL) levels of participants in the intervention group.

  2. The Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 3 months ]

    The investigators want to see the effect of Hibiscus Sabdariffa on the sleep quality of participants in the intervention group.

    The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.


  3. The Depression, Anxiety, and Stress Scales (DASS) [ Time Frame: 3 months ]

    The investigators want to see the effect of Hibiscus Sabdariffa on the stress levels of participants in the intervention group.

    The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress.

    The DASS is composed of three 14-item subscales, for a total of 42 questions. DASS scores can be 0-42 on each subscale. Total score is calculated by summing the scores for each subscale.

    For each of the three subscales, a higher score indicates a more severe negative emotional state.


  4. The Perceived Stress Scale (PSS) [ Time Frame: 3 months ]

    The investigators want to see the effect of Hibiscus Sabdariffa on the stress levels of participants in the intervention group.

    Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

    • Scores ranging from 0-13 would be considered low stress.
    • Scores ranging from 14-26 would be considered moderate stress.
    • Scores ranging from 27-40 would be considered high perceived stress.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Additional Information:
Publications:

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Responsible Party: Sulaiman AlRajhi Colleges
ClinicalTrials.gov Identifier: NCT03804801    
Other Study ID Numbers: SulimanAC-Hibiscus
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases