<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20250603066044N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-07-13</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of hibiscus flower extract on blood pressure.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of Althaea officinalis extract oral solution on blood pressure levels in patients with high blood pressure (HTN): A randomized double blind clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84065</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The permutation block randomization method is used. Blocking is usually used to balance the number of samples allocated to each of the study groups. This feature helps researchers to ensure that the number of samples allocated to each of the study groups is equal in cases where interim analyses are needed during the sampling process. In this two-group clinical trial, the block size is 4. The allocation ratio between the two groups is 1:1. The randomization tool is the blockrand package of R software. For concealment, we use random allocation concealment. This method is used to perform random sequence on participants in such a way that the assigned group is not known before the individual is assigned. Using sealed opaque envelopes with a random sequence, in which each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the envelopes are sealed and placed in a box in order. When participant registration begins, based on the order of entry into the study, one of the envelopes is opened in order and the assigned group of that participant is revealed, Blinding description: To control the entry criteria for the study, the initial visit will be conducted by a physician. Coded medications will be prepared and delivered to the study assistant, who will not be informed about the types of medications. The codes will be sent separately in sealed envelopes so that neither the researcher nor the patient will be aware of the contents of the medication container until the end of the study. The medications will be administered to the patients by the study assistant using a random block method. Patients will be divided into two groups (35 individuals in each group) using a randomization list prepared by a statistical consultant.</study_design>
      <phase>3</phase>
      <hc_freetext>Essential (primary) hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: In addition to antihypertensive medications, an oral solution of hibiscus extract prepared by Zarband Pharmaceutical Company will be administered twice daily for 2 weeks, with each dose being 10 milliliters. Intervention 2: Control group: Placebo: In addition to antihypertensive drugs, a carrier solution containing an oral extract of hibiscus flower without active ingredients, prepared at the Faculty of Pharmacy in Ahvaz, will be administered for 2 weeks, twice a day, with each dose being 10 milliliters.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is In this regard, permission must be obtained from the patients and consultation should be made with the project colleague</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Neda Sistani karampour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd,Ahvaz Jundishapur University  of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6155833651</zip>
        <telephone>+98 61 3338 0031</telephone>
        <email>N.sistani1386@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Neda sistani karampour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd,Ahvaz Jundishapur University of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6155833651</zip>
        <telephone>+98 61 3338 0031</telephone>
        <email>N.sistani1386@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Blood pressure of 90/140 mmHg or higher
Patients should only use oral antihypertensive medications</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Lactation
Severe renal failure
Liver failure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: In addition to antihypertensive medications, an oral solution of hibiscus extract prepared by Zarband Pharmaceutical Company will be administered twice daily for 2 weeks, with each dose being 10 milliliters</i_keyword>
      <i_keyword>Control group: Placebo: In addition to antihypertensive drugs, a carrier solution containing an oral extract of hibiscus flower without active ingredients, prepared at the Faculty of Pharmacy in Ahvaz, will be administered for 2 weeks, twice a day, with each dose being 10 milliliters</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measuring Blood Pressure. Timepoint: It will be measured 5 times over the course of 2 weeks. Method of measurement: Using a blood pressure monitor.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>FBS TG LDL HDL. Timepoint: Beginning and end of the test. Method of measurement: Blood sampling.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Ahvaz jundishapur university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-04-18</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapur  University of Medical Sciences</contact_name>
        <contact_address>Golestat  Blvd,Ahvaz Jundishapur University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
