<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03804801</url>
  </required_header>
  <id_info>
    <org_study_id>SulimanAC-Hibiscus</org_study_id>
    <nct_id>NCT03804801</nct_id>
  </id_info>
  <brief_title>Effect of Hibiscus Sabdariffa on Blood Pressure in a University Population</brief_title>
  <official_title>Effect of Hibiscus Sabdariffa on Blood Pressure in a University Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sulaiman AlRajhi Colleges</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sulaiman AlRajhi Colleges</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypertension, also known as high blood pressure, is a very common disease and is considered&#xD;
      &quot;the silent killer&quot;. Hypertension is responsible for at least 45% of deaths due to heart&#xD;
      disease, and 51% of deaths due to stroke. Hypertension plays a part in the worry of heart&#xD;
      disease, stroke and kidney failure and premature mortality and disability. If hypertension&#xD;
      goes uncontrolled, in the long term, it will cause serious complications, most of which will&#xD;
      necessitate costly interventions to be solved and managed. Apparently, these interventions&#xD;
      may include cardiac bypass surgery, carotid artery surgery and dialysis, draining individual&#xD;
      and government budgets. Recent studies show that hibiscus (Hibiscus sabdariffa) tea can lower&#xD;
      blood pressure as effectively as some standard anti-hypertensive drugs can. Hibiscus is&#xD;
      widely consumed around the world as a ruby-colored, lemony beverage. Hibiscus is safe and,&#xD;
      unlike most blood pressure drugs, rarely causes side effects. All of the studies the&#xD;
      investigators found in the literature were either underpowered or inconclusive. All of these&#xD;
      studies recommended further studies with bigger samples to accurately assess the effect of&#xD;
      hibiscus sabdariffa on blood pressure in hypertensive patients. The aim of this study is to&#xD;
      assess the feasibility of a large-scale study assessing the effectiveness of Hibiscus&#xD;
      sabdariffa on lowering blood pressure in individuals with elevated blood pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Question:&#xD;
&#xD;
      Will daily consumption of 240 ml of Hibiscus sabdariffa reduce blood pressure in individuals&#xD;
      with elevated blood pressure?&#xD;
&#xD;
      Research Objectives:&#xD;
&#xD;
      Primary: To conduct a feasibility study investigating the effect of daily consumption of 240&#xD;
      ml of Hibiscus sabdariffa on blood pressure in individuals with elevated blood pressure&#xD;
&#xD;
      Secondary: To investigate the effect of daily consumption of 240 ml of Hibiscus sabdariffa on&#xD;
      low-density lipoprotein (LDL) levels&#xD;
&#xD;
      Secondary: To investigate the effect of daily consumption of 240 ml of Hibiscus sabdariffa on&#xD;
      sleep quality&#xD;
&#xD;
      Secondary: To investigate the effect of daily consumption of 240 ml of Hibiscus sabdariffa on&#xD;
      stress levels&#xD;
&#xD;
      Trial Design:&#xD;
&#xD;
      This study is an open-label randomized controlled trial. The intervention arm is going to&#xD;
      receive a 240 ml serving of hibiscus sabdariffa (sour tea) 1 time a day. The control arm will&#xD;
      not have a placebo; hence, &quot;open-label&quot;.&#xD;
&#xD;
      Allocation:&#xD;
&#xD;
      The investigators will use simple randomization in this trial. Each participant will have an&#xD;
      assigned code number, which will be generated by a computer program, and then these numbers&#xD;
      will randomly be placed into one of the two study arms by the same computer program. The&#xD;
      participants will know to which study arm they belong to once the trial is officially&#xD;
      started.&#xD;
&#xD;
      Study Setting:&#xD;
&#xD;
      This study will be conducted in Sulaiman Al-Rajhi Colleges (SRC) in Al-Qassim Region, Kingdom&#xD;
      of Saudi Arabia&#xD;
&#xD;
      Interventions:&#xD;
&#xD;
      Participants will drink hibiscus sabdariffa 1 time a day for 3 months. Hibiscus sabdariffa&#xD;
      will be given to the participants in the form of boxes filled with small paper bags filled&#xD;
      with the herb (just like teabags). The participant will immerse the teabag in 240 milliliters&#xD;
      of cold drinking water (the same volume as in a regular paper cup used for tea) and let it&#xD;
      settle for 2-3 minutes before drinking it. This will be done 1 time a day for 3 whole months.&#xD;
&#xD;
      The participant will be given a month's supply on the first day of the trial, and additional&#xD;
      supply will be given during the follow-up visits. Reminder text messages (SMS) will be sent&#xD;
      regularly (every 2-3 days) to the participant to remind the participants of drinking the&#xD;
      hibiscus. Regarding the study outcomes, the participant's blood pressure will be measured&#xD;
      using a standardized manual sphygmomanometer at the times of measurement. Regarding the blood&#xD;
      LDL levels, the participant will have a blood sample withdrawn and analyzed for LDL levels at&#xD;
      the times of measurement. Regarding sleep quality and stress levels, the participant will&#xD;
      fill out the respective questionnaires at the times of measurement.&#xD;
&#xD;
      Before initiating the trial, each participant will have the details of the trial, the&#xD;
      benefits and risks of the intervention, and the possible outcome of the trial explained to&#xD;
      the participants by one of the study investigators. To insure adherence to the intervention,&#xD;
      participants in the intervention group will be sent either a text message (SMS) or an e-mail&#xD;
      reminding the participants to take the hibiscus tea. The option of either SMS or e-mail&#xD;
      depends upon the participant's preference. Any questions or concerns from the side of the&#xD;
      participants will be cleared up before initiating the trial and during upcoming follow-up&#xD;
      visits.&#xD;
&#xD;
      Multiple randomized controlled trials showed that ingestion of hibiscus tea significantly&#xD;
      lowered blood pressure in hypertensive patients. Moreover, some studies showed that ingestion&#xD;
      of hibiscus tea lowered LDL levels in addition to other positive changes in blood lipid&#xD;
      profiles of patients. The investigators also want to assess if there is an effect of&#xD;
      ingestion of hibiscus tea on sleep quality and stress levels.&#xD;
&#xD;
      Sample Size:&#xD;
&#xD;
      Sample size is based on feasibility trial, to test whether this can be done, not on sample&#xD;
      size statistics. Also, the target population is pre-hypertensive individuals in a university&#xD;
      setting (this includes students, teaching staff, administration staff, and workers). Since&#xD;
      there is a definite effect of hibiscus on blood pressure, the investigators recognized that&#xD;
      the investigators need a relatively small sample size for the investigators' trial. 40&#xD;
      subjects (randomized into two arms of 20 subjects each) is the required number of&#xD;
      participants for the study in order to not comprise the statistical significance and power of&#xD;
      the results.&#xD;
&#xD;
      Recruitment:&#xD;
&#xD;
      The principal investigators will invite subjects to participate in the study via sending&#xD;
      e-mails to all university individuals. Individuals willing to participate in the trial will&#xD;
      sign up to participate in the trial using an online registration form. The investigators used&#xD;
      the definition of elevated blood pressure (pre-hypertension) given by the 2017 American Heart&#xD;
      Association Guidelines: &quot;Elevated blood pressure (pre-hypertension): Systolic blood pressure&#xD;
      [SBP] between 120-129 mm Hg and diastolic blood pressure [DBP] less than 80 mm Hg.&quot; (15) The&#xD;
      investigators also used the definition of essential hypertension given by the 2017 American&#xD;
      Heart Association Guidelines: &quot;Hypertension Stage I: Systolic blood pressure [SBP] 130 - 139&#xD;
      mm Hg OR diastolic blood pressure [DBP] 80 - 89 mm Hg. Hypertension Stage II: Systolic blood&#xD;
      pressure [SBP] at least 140 mm Hg OR diastolic blood pressure [DBP] at least 90 mm Hg&quot; (15)&#xD;
      The target population is individuals with elevated or Stage I hypertensive levels of blood&#xD;
      pressure. This means the investigators will be recruiting individuals with a systolic blood&#xD;
      pressure of 120 - 139 mm Hg and a diastolic blood pressure of 80 - 89 mm Hg. After being&#xD;
      recognized as eligible participants via the inclusion / exclusion criteria, these&#xD;
      participants will be randomized into one of the two study arms.&#xD;
&#xD;
      Data Collection:&#xD;
&#xD;
      Blood pressure (the primary outcome) will be measured regularly during the trial;&#xD;
      specifically, at the start of the trial, at 1 month after the official start, at 2 months&#xD;
      after the official start, and at 3 months after the official start (at the end of the trial).&#xD;
      Measurement will be done during curricular activity hours in the university clinic, on&#xD;
      multiple days of each measurement week (to accommodate for the schedule differences of&#xD;
      participants). The study investigators will measure each participant's blood pressure using a&#xD;
      standardized sphygmomanometer.&#xD;
&#xD;
      Low-density lipoprotein [LDL] (a secondary outcome) will be measured twice during the trial;&#xD;
      specifically, once at the official start of the trial, and once at 3 months after the&#xD;
      official start (at the end of the trial). A blood sample will be drawn from the participant&#xD;
      by the study investigators.&#xD;
&#xD;
      Sleep quality and stress levels (secondary outcomes) will be measured twice during the trial;&#xD;
      specifically, once at the official start of the trial, and once at 3 months after the&#xD;
      official start (at the end of the trial). The participant will fill out a validated&#xD;
      questionnaire form regarding sleep quality (the Pittsburgh Sleep Quality Index [PSQI]) and&#xD;
      another form regarding stress levels (the Depression, Anxiety, &amp; Stress Scales [DASS] AND the&#xD;
      Perceived Stress Scale [PSS]).&#xD;
&#xD;
      In addition, during each measurement point, the study investigators will inquire about the&#xD;
      participants' adherence to the intervention and will ask about any possible adverse effects&#xD;
      caused by the intervention. Time will be given to clear up any concerns or questions the&#xD;
      participants may have regarding the trial or its details.&#xD;
&#xD;
      For follow-up, the participants will visit the study investigators at the official start of&#xD;
      the trial, at 1 month after the official start, at 2 months after the official start, and at&#xD;
      3 months after the official start (at the end of the trial).&#xD;
&#xD;
      Statistical Methods:&#xD;
&#xD;
      The investigators will analyze the collected data using the IBM SPSS Statistics software. The&#xD;
      investigators will use the latest version (Version 25).&#xD;
&#xD;
      The investigators will analyze the difference between the mean blood pressures of the&#xD;
      intervention group prior to taking the hibiscus tea and the mean blood pressures of the&#xD;
      intervention group after taking the hibiscus tea (at the end of the trial) using the paired&#xD;
      t-tests. The investigators will analyze the difference between the mean blood pressures of&#xD;
      the control group and the mean blood pressures of the intervention group (both before and&#xD;
      after the intervention) using the unpaired t-tests.&#xD;
&#xD;
      Similarly, the difference between LDL levels of the control group and LDL levels of the&#xD;
      intervention group will be analyzed via the unpaired t-tests.&#xD;
&#xD;
      The differences in sleep quality and stress levels between the control group and the&#xD;
      intervention group will be analyzed using paired t-tests. The differences in sleep quality&#xD;
      and stress levels in the intervention group before and after the intervention will be&#xD;
      analyzed using paired t-tests as well.&#xD;
&#xD;
      Confidentiality:&#xD;
&#xD;
      Informed consent will be offered to every participant. The purpose of the study will be&#xD;
      explained to all the participants and the investigators will ensure strict confidentiality&#xD;
      and anonymity before proceeding with the study. The participants will be placed individually&#xD;
      in the university clinic and only the investigators will record the results in order for the&#xD;
      data collected to be totally confidential.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">June 29, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Pressure (BP)</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators want to see the effect of Hibiscus Sabdariffa on the blood pressure of participants in the intervention group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Low-density lipoprotein (LDL) levels</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators want to see the effect of Hibiscus Sabdariffa on the low-density lipoprotein (LDL) levels of participants in the intervention group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators want to see the effect of Hibiscus Sabdariffa on the sleep quality of participants in the intervention group.&#xD;
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 &quot;component&quot; scores, each of which has a range of 0-3 points. In all cases, a score of &quot;0&quot; indicates no difficulty, while a score of &quot;3&quot; indicates severe difficulty. The seven component scores are then added to yield one &quot;global&quot; score, with a range of 0-21 points, &quot;0&quot; indicating no difficulty and &quot;21&quot; indicating severe difficulties in all areas.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Depression, Anxiety, and Stress Scales (DASS)</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators want to see the effect of Hibiscus Sabdariffa on the stress levels of participants in the intervention group.&#xD;
The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress.&#xD;
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.&#xD;
For each of the three subscales, a higher score indicates a more severe negative emotional state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Perceived Stress Scale (PSS)</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators want to see the effect of Hibiscus Sabdariffa on the stress levels of participants in the intervention group.&#xD;
Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.&#xD;
Scores ranging from 0-13 would be considered low stress.&#xD;
Scores ranging from 14-26 would be considered moderate stress.&#xD;
Scores ranging from 27-40 would be considered high perceived stress.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Elevated Blood Pressure</condition>
  <arm_group>
    <arm_group_label>Intervention Arm (or Group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will receive the intervention (Hibiscus Sabdariffa extract supplement)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm (or Group)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This arm will receive no intervention whatsoever, not even placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Hibiscus Sabdariffa</intervention_name>
    <description>The extract of the plant Hibiscus Sabdariffa, also known as sour or red tea</description>
    <arm_group_label>Intervention Arm (or Group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both sexes&#xD;
&#xD;
          -  Age 18 - 70 years&#xD;
&#xD;
          -  Abnormal blood pressure (SBP 120 - 139 mm Hg; DBP 80 - 89 mm Hg)&#xD;
&#xD;
          -  Sulaiman Al Rajhi Colleges affiliate (student, teaching staff member, administrative&#xD;
             staff member, worker)&#xD;
&#xD;
          -  No regular medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic to hibiscus sabdariffa&#xD;
&#xD;
          -  Normal blood pressure (SBP ≤ 120 mm Hg; DBP ≤ 80 mm Hg)&#xD;
&#xD;
          -  Essential hypertension Stage II or higher (SBP ≥ 140 mm Hg; DBP ≥ 90 mm Hg)&#xD;
&#xD;
          -  Hypertension due to secondary causes&#xD;
&#xD;
          -  Other comorbid conditions (diabetes mellitus, renal failure, coronary artery disease,&#xD;
             heart failure, malignant hypertension [BP ≥ 180/110], etc.)&#xD;
&#xD;
          -  Regular hibiscus user&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any metabolic or malabsorptive disease that may interfere with absorption of hibiscus&#xD;
             sabdariffa (e.g. coeliac disease, chronic pancreatitis, etc.)&#xD;
&#xD;
          -  Diagnosis of a sleep disorder or use of medication that interferes with sleep (either&#xD;
             causing drowsiness or wakefulness)&#xD;
&#xD;
          -  Diagnosis of a mood disorder or stress disorder&#xD;
&#xD;
          -  Taking psychiatric medication (mood stabilizers, antidepressants, anxiolytics, or&#xD;
             antipsychotics)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>https://www.motherearthnews.com/natural-health/herbal-remedies/lower-blood-pressure-naturally-zmgz11zrog</url>
    <description>Ogden Publications, Inc., &amp; Ogden Publications, Inc. (n.d.). Lower Blood Pressure Naturally With Hibiscus Tea</description>
  </link>
  <link>
    <url>https://www.webmd.com/vitamins/ai/ingredientmono-211/hibiscus</url>
    <description>Hibiscus: Uses, Side Effects, Interactions, Dosage, and Warning</description>
  </link>
  <link>
    <url>https://www.heart.org/-/media/data-import/downloadables/hypertension-guideline-highlights-flyer-ucm_497841.pdf</url>
    <description>Hypertension Highlights 2017 - American Heart Association</description>
  </link>
  <link>
    <url>http://www2.psy.unsw.edu.au/dass/over.htm</url>
    <description>Psychology Foundation of Australia - Overview of Depression, Anxiety, &amp; Stress Scales (DASS)</description>
  </link>
  <link>
    <url>http://www2.psy.unsw.edu.au/dass/Download%20files/Dass42.pdf</url>
    <description>Depression, Anxiety, and Stress Scales (DASS) Questionnaire</description>
  </link>
  <link>
    <url>https://das.nh.gov/wellness/docs/percieved%20stress%20scale.pdf</url>
    <description>Perceived Stress Scale (PSS) Questionnaire</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>24343464</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26600645</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26289514</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17315307</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15330492</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19962289</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25875025</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19801187</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>2748771</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03804801
org study id: SulimanAC-Hibiscus
nct id: NCT03804801
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
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.
Research Question:

      Will daily consumption of 240 ml of Hibiscus sabdariffa reduce blood pressure in individuals
      with elevated blood pressure?

      Research Objectives:

      Primary: To conduct a feasibility study investigating the effect of daily consumption of 240
      ml of Hibiscus sabdariffa on blood pressure in individuals with elevated blood pressure

      Secondary: To investigate the effect of daily consumption of 240 ml of Hibiscus sabdariffa on
      low-density lipoprotein (LDL) levels

      Secondary: To investigate the effect of daily consumption of 240 ml of Hibiscus sabdariffa on
      sleep quality

      Secondary: To investigate the effect of daily consumption of 240 ml of Hibiscus sabdariffa on
      stress levels

      Trial Design:

      This study is an open-label randomized controlled trial. The intervention arm is going to
      receive a 240 ml serving of hibiscus sabdariffa (sour tea) 1 time a day. The control arm will
      not have a placebo; hence, "open-label".

      Allocation:

      The investigators will use simple randomization in this trial. Each participant will have an
      assigned code number, which will be generated by a computer program, and then these numbers
      will randomly be placed into one of the two study arms by the same computer program. The
      participants will know to which study arm they belong to once the trial is officially
      started.

      Study Setting:

      This study will be conducted in Sulaiman Al-Rajhi Colleges (SRC) in Al-Qassim Region, Kingdom
      of Saudi Arabia

      Interventions:

      Participants will drink hibiscus sabdariffa 1 time a day for 3 months. Hibiscus sabdariffa
      will be given to the participants in the form of boxes filled with small paper bags filled
      with the herb (just like teabags). The participant will immerse the teabag in 240 milliliters
      of cold drinking water (the same volume as in a regular paper cup used for tea) and let it
      settle for 2-3 minutes before drinking it. This will be done 1 time a day for 3 whole months.

      The participant will be given a month's supply on the first day of the trial, and additional
      supply will be given during the follow-up visits. Reminder text messages (SMS) will be sent
      regularly (every 2-3 days) to the participant to remind the participants of drinking the
      hibiscus. Regarding the study outcomes, the participant's blood pressure will be measured
      using a standardized manual sphygmomanometer at the times of measurement. Regarding the blood
      LDL levels, the participant will have a blood sample withdrawn and analyzed for LDL levels at
      the times of measurement. Regarding sleep quality and stress levels, the participant will
      fill out the respective questionnaires at the times of measurement.

      Before initiating the trial, each participant will have the details of the trial, the
      benefits and risks of the intervention, and the possible outcome of the trial explained to
      the participants by one of the study investigators. To insure adherence to the intervention,
      participants in the intervention group will be sent either a text message (SMS) or an e-mail
      reminding the participants to take the hibiscus tea. The option of either SMS or e-mail
      depends upon the participant's preference. Any questions or concerns from the side of the
      participants will be cleared up before initiating the trial and during upcoming follow-up
      visits.

      Multiple randomized controlled trials showed that ingestion of hibiscus tea significantly
      lowered blood pressure in hypertensive patients. Moreover, some studies showed that ingestion
      of hibiscus tea lowered LDL levels in addition to other positive changes in blood lipid
      profiles of patients. The investigators also want to assess if there is an effect of
      ingestion of hibiscus tea on sleep quality and stress levels.

      Sample Size:

      Sample size is based on feasibility trial, to test whether this can be done, not on sample
      size statistics. Also, the target population is pre-hypertensive individuals in a university
      setting (this includes students, teaching staff, administration staff, and workers). Since
      there is a definite effect of hibiscus on blood pressure, the investigators recognized that
      the investigators need a relatively small sample size for the investigators' trial. 40
      subjects (randomized into two arms of 20 subjects each) is the required number of
      participants for the study in order to not comprise the statistical significance and power of
      the results.

      Recruitment:

      The principal investigators will invite subjects to participate in the study via sending
      e-mails to all university individuals. Individuals willing to participate in the trial will
      sign up to participate in the trial using an online registration form. The investigators used
      the definition of elevated blood pressure (pre-hypertension) given by the 2017 American Heart
      Association Guidelines: "Elevated blood pressure (pre-hypertension): Systolic blood pressure
      [SBP] between 120-129 mm Hg and diastolic blood pressure [DBP] less than 80 mm Hg." (15) The
      investigators also used the definition of essential hypertension given by the 2017 American
      Heart Association Guidelines: "Hypertension Stage I: Systolic blood pressure [SBP] 130 - 139
      mm Hg OR diastolic blood pressure [DBP] 80 - 89 mm Hg. Hypertension Stage II: Systolic blood
      pressure [SBP] at least 140 mm Hg OR diastolic blood pressure [DBP] at least 90 mm Hg" (15)
      The target population is individuals with elevated or Stage I hypertensive levels of blood
      pressure. This means the investigators will be recruiting individuals with a systolic blood
      pressure of 120 - 139 mm Hg and a diastolic blood pressure of 80 - 89 mm Hg. After being
      recognized as eligible participants via the inclusion / exclusion criteria, these
      participants will be randomized into one of the two study arms.

      Data Collection:

      Blood pressure (the primary outcome) will be measured regularly during the trial;
      specifically, at the start of the trial, at 1 month after the official start, at 2 months
      after the official start, and at 3 months after the official start (at the end of the trial).
      Measurement will be done during curricular activity hours in the university clinic, on
      multiple days of each measurement week (to accommodate for the schedule differences of
      participants). The study investigators will measure each participant's blood pressure using a
      standardized sphygmomanometer.

      Low-density lipoprotein [LDL] (a secondary outcome) will be measured twice during the trial;
      specifically, once at the official start of the trial, and once at 3 months after the
      official start (at the end of the trial). A blood sample will be drawn from the participant
      by the study investigators.

      Sleep quality and stress levels (secondary outcomes) will be measured twice during the trial;
      specifically, once at the official start of the trial, and once at 3 months after the
      official start (at the end of the trial). The participant will fill out a validated
      questionnaire form regarding sleep quality (the Pittsburgh Sleep Quality Index [PSQI]) and
      another form regarding stress levels (the Depression, Anxiety, & Stress Scales [DASS] AND the
      Perceived Stress Scale [PSS]).

      In addition, during each measurement point, the study investigators will inquire about the
      participants' adherence to the intervention and will ask about any possible adverse effects
      caused by the intervention. Time will be given to clear up any concerns or questions the
      participants may have regarding the trial or its details.

      For follow-up, the participants will visit the study investigators at the official start of
      the trial, at 1 month after the official start, at 2 months after the official start, and at
      3 months after the official start (at the end of the trial).

      Statistical Methods:

      The investigators will analyze the collected data using the IBM SPSS Statistics software. The
      investigators will use the latest version (Version 25).

      The investigators will analyze the difference between the mean blood pressures of the
      intervention group prior to taking the hibiscus tea and the mean blood pressures of the
      intervention group after taking the hibiscus tea (at the end of the trial) using the paired
      t-tests. The investigators will analyze the difference between the mean blood pressures of
      the control group and the mean blood pressures of the intervention group (both before and
      after the intervention) using the unpaired t-tests.

      Similarly, the difference between LDL levels of the control group and LDL levels of the
      intervention group will be analyzed via the unpaired t-tests.

      The differences in sleep quality and stress levels between the control group and the
      intervention group will be analyzed using paired t-tests. The differences in sleep quality
      and stress levels in the intervention group before and after the intervention will be
      analyzed using paired t-tests as well.

      Confidentiality:

      Informed consent will be offered to every participant. The purpose of the study will be
      explained to all the participants and the investigators will ensure strict confidentiality
      and anonymity before proceeding with the study. The participants will be placed individually
      in the university clinic and only the investigators will record the results in order for the
      data collected to be totally confidential.
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
primary purpose: Treatment
masking: None (Open Label)
measure: Blood Pressure (BP)
time frame: 3 months
description: The investigators want to see the effect of Hibiscus Sabdariffa on the blood pressure of participants in the intervention group.
measure: Low-density lipoprotein (LDL) levels
time frame: 3 months
description: The investigators want to see the effect of Hibiscus Sabdariffa on the low-density lipoprotein (LDL) levels of participants in the intervention group.
measure: The Pittsburgh Sleep Quality Index (PSQI)
time frame: 3 months
description: 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.
measure: The Depression, Anxiety, and Stress Scales (DASS)
time frame: 3 months
description: 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.
measure: The Perceived Stress Scale (PSS)
time frame: 3 months
description: 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.
arm group label: Intervention Arm (or Group)
arm group type: Experimental
description: This arm will receive the intervention (Hibiscus Sabdariffa extract supplement)
arm group label: Control Arm (or Group)
arm group type: No Intervention
description: This arm will receive no intervention whatsoever, not even placebo
intervention type: Dietary Supplement
intervention name: Hibiscus Sabdariffa
description: The extract of the plant Hibiscus Sabdariffa, also known as sour or red tea
arm group label: Intervention Arm (or Group)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
url: https://www.motherearthnews.com/natural-health/herbal-remedies/lower-blood-pressure-naturally-zmgz11zrog
description: Ogden Publications, Inc., & Ogden Publications, Inc. (n.d.). Lower Blood Pressure Naturally With Hibiscus Tea
url: https://www.webmd.com/vitamins/ai/ingredientmono-211/hibiscus
description: Hibiscus: Uses, Side Effects, Interactions, Dosage, and Warning
url: https://www.heart.org/-/media/data-import/downloadables/hypertension-guideline-highlights-flyer-ucm_497841.pdf
description: Hypertension Highlights 2017 - American Heart Association
url: http://www2.psy.unsw.edu.au/dass/over.htm
description: Psychology Foundation of Australia - Overview of Depression, Anxiety, & Stress Scales (DASS)
url: http://www2.psy.unsw.edu.au/dass/Download%20files/Dass42.pdf
description: Depression, Anxiety, and Stress Scales (DASS) Questionnaire
url: https://das.nh.gov/wellness/docs/percieved%20stress%20scale.pdf
description: Perceived Stress Scale (PSS) Questionnaire
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PMID: 26600645
citation: 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
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PMID: 17315307
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PMID: 15330492
citation: 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
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PMID: 25875025
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PMID: 19801187
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PMID: 2748771
responsible party type: Sponsor
mesh term: Hypertension