<?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>IRCT20200506047325N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-18</date_registration>
      <primary_sponsor>Golestan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of anti-hypertensive effect of jujube fruit</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of antihypertensive effect of antioxidant enriched Ziziphus jujuba fruit extract in patients with primary hypertension: A randomized, double-blind, placebo controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59980</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random assignment list will be computer generated with a 1:1 allocation, stratified by recruitment site, using random block size of four. Using concealed in sequentially numbered, sealed, opaque envelopes (SNOSE), participants will enter the blocks in such a way that an equal number of each assigned group. Allocation will be done by randomly selecting one of the arrangements and assigning the next part of the participants to the study groups according to the specified sequence. And kept by the hospital pharmacist of the center, Blinding description: To maintain blindness in patients, the drug and placebo are the same in shape and appearance; Also, the evaluator is not aware of the type of drugs in the intervention groups, so that multi-digit numerical codes are written on the drug packages that only the main person in charge of the research is aware of.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Receiving routine drug treatment + enriched antioxidant extract of Ziziphus jujuba fruit for 12 weeks (3 months). Patients will be evaluated for symptoms at 14 weeks and 16 weeks after the end of the study. Intervention 2: Control group: Receiving routine drugs+ placebo for 12 weeks (3 months).</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ayesheh Enayati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shastkola Road</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14395-477</zip>
        <telephone>+98 17 3245 1434</telephone>
        <email>enayati_phyto@yahoo.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ayesheh Enayati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shastkola Road</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14395-477</zip>
        <telephone>+98 17 3245 1434</telephone>
        <email>enayati_phyto@yahoo.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>120 mmHg &lt;  blood pressure &lt;  mmHg 160 (Pre- and stage 1 hypertension)
Age over 18, female or male
Voluntary participation and written consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Other heart diseases
Secondary blood pressure
Serum Potassium &gt; 5.5 mmol/L or &lt; 3.5 mmol/L
double serum creatinine in the last 6 months
Severe complications of diabetes or serious macrovascular events within 6 months (for example, cerebral hemorrhage, cerebral infarction, or acute myocardial infarction)
Recent infection in the last 4 weeks
Primary or secondary kidney disease (e.g., IgA nephropathy, membranous nephropathy, or lupus nephritis)
Any cancer and malignancy
Severe mental disorder
Pregnant or lactating women or women who are planning to become pregnant or women who are not using appropriate contraceptive methods
Drug allergies or jujube allergies
Participate in other clinical trials
Use of other herbal medicines to control the symptoms of the present disease
History of smoking, drugs
Other conditions that the researchers considered inappropriate in this clinical study</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Receiving routine drug treatment + enriched antioxidant extract of Ziziphus jujuba fruit for 12 weeks (3 months). Patients will be evaluated for symptoms at 14 weeks and 16 weeks after the end of the study.</i_keyword>
      <i_keyword>Control group: Receiving routine drugs+ placebo for 12 weeks (3 months)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: 0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit). Method of measurement: Mercury sphygmomanometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>SCr. Timepoint: 0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit). Method of measurement: Blood and urine tests.</sec_outcome>
      <sec_outcome>EGFR. Timepoint: 0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit). Method of measurement: Blood and urine tests.</sec_outcome>
      <sec_outcome>Serum Albumin. Timepoint: 0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit). Method of measurement: Blood and urine tests.</sec_outcome>
      <sec_outcome>Serum Potassium. Timepoint: 0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit). Method of measurement: Blood and urine tests.</sec_outcome>
      <sec_outcome>EGC. Timepoint: 0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit). Method of measurement: Electrocardiograph.</sec_outcome>
      <sec_outcome>Liver enzymes. Timepoint: 0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit). Method of measurement: Blood tests.</sec_outcome>
      <sec_outcome>ACE2 enzyme. Timepoint: 0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit). Method of measurement: Bloodtests.</sec_outcome>
      <sec_outcome>Serum Nitric oxide. Timepoint: 0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit). Method of measurement: Blood tests.</sec_outcome>
      <sec_outcome>Lipid profiles. Timepoint: 0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit). Method of measurement: Blood tests.</sec_outcome>
      <sec_outcome>Diet. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Diet with 24Recall checklist.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>South Khorasan Academic center for education, culture and research</sponsor_name>
      <sponsor_name>Food and Bio-Nanotech International Research Center (Fabiano)</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Golestan University of Medical Sciences</source_name>
      <source_name>South Khorasan Academic center for education, culture and research</source_name>
      <source_name>Food and Bio-Nanotech International Research Center (Fabiano)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-31</approval_date>
        <contact_name>Research Ethics Committees of Golestan University of Medical Sciences</contact_name>
        <contact_address>Shastkola Road Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
