<?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>IRCT20201227049850N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-03</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of  Effect of Internal Septum of Walnut on Blood Lipids</public_title>
      <acronym></acronym>
      <scientific_title>Initial Evaluation of Effect of Internal Septum of Juglans regia L. on Blood Lipids in Patients with Dyslipidemia: A Double-blind Placebo-controlled Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53277</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization will be used to balance the number of samples assigned to each group. For this purpose, 10 blocks of 8 members with different sequences, but equal proportions are composed of two groups A and B and are numbered from 1 to 10. With the RANDBETWEEN function, 10 random number between 1 and 10 is specified, the corresponding blocks of these numbers are placed in a row, and a random chain of groups A and B is formed. Group A is selected as the intervention group and group B as the control group. In order to conceal the random allocation, 80 envelopes with aluminum wrappers (in order to obscure the contents of the envelopes) will be prepared and the letters A and B will be recorded on the cards and the cards will be placed in the envelopes in a random chain. Finally, by entering the study, patients will open the envelopes in order and their assigned group will be revealed, Blinding description: In this study, both of patients and researcher are blinded. Placebo is prepared the same as the drug capsule. Drug and placebo are coded into A and B by  the third supervisor and randomized by block randomization method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dyslipidemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group is treated with an oral capsule containing 500 mg of internal septum of Juglans regia L. extract three times a day for 12 weeks. Intervention 2: Control group: The control group is treated with an oral capsule containing 500 mg pectin (placebo) three times a day for 12 weeks.</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 The release schedule is not yet known</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soha Namazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 43, Golestan Complex, Golab Ave, Sadeghiye Squere, Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1451974681</zip>
        <telephone>+98 21 4441 2540</telephone>
        <email>namazisoha@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soha Namazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 43, Golestan Complex, Golab Ave, Sadeghiye Square, Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1451974681</zip>
        <telephone>+98 21 4441 2540</telephone>
        <email>namazisoha@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Obtain informed consent from patients.
Patients aged 25 to 70 years.
Patients with dyslipidemia who have serum LDL-C more than goal based on European Heart Association 2019 guideline despite receiving the maximum or maximum tolerable dose of  statins. The therapeutic goals of LDL-C blood levels varies between 55 and 100 mg/dl based on other conditions and diseases in the study participants.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of walnut allergy
Taking other herbal medicines
Immune system defects
Pregnancy
Renal failure (eGFR &lt;30 mL / min / 1.73m2)
Liver failure (AST or ALT&gt; × 3 ULN)
Uncontrolled thyroid disease (TSH &lt;LLN or TSH&gt; 1.5 × ULN)
TG&gt;350 mg/dl
Concomitant use of any medication containing estrogen or progesterone, systemic glucocorticoids, cyclosporine, tacrolimus, everolimus, sirolimus, antipsychotic drugs, psychotropic substances or alcohol
Neurological or psychiatric disorders that affect the acceptance of medication and the correct implementation of the study protocol
Lactation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E78.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hyperlipidemia, Unspecified</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: The intervention group is treated with an oral capsule containing 500 mg of internal septum of Juglans regia L. extract three times a day for 12 weeks.</i_keyword>
      <i_keyword>Control group: The control group is treated with an oral capsule containing 500 mg pectin (placebo) three times a day for 12 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Low-density lipoprotein cholesterol (LDL-C). Timepoint: Zero and 12 weeks after intervention. Method of measurement: Serum level measurement.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum level of lipoprotein(a). Timepoint: Zero and 12 weeks after intervention. Method of measurement: Serum level measurement.</sec_outcome>
      <sec_outcome>Serum level of triglycerides. Timepoint: Zero and 12 weeks after intervention. Method of measurement: Serum level measurement.</sec_outcome>
      <sec_outcome>Serum level of total cholesterol. Timepoint: Zero and 12 weeks after intervention. Method of measurement: Serum level measurement.</sec_outcome>
      <sec_outcome>Cholesterol ratio(low-density lipoprotein cholesterol/high-density lipoprotein cholesterol). Timepoint: Zero and 12 weeks after intervention. Method of measurement: Calculate Low Density lipoprotein cholesterol divided by high Density lipoprotein cholesterol.</sec_outcome>
      <sec_outcome>Atherogenic index (log triglycerides/high-density lipoprotein). Timepoint: Zero and 12 weeks after intervention. Method of measurement: Calculate the logarithm of high-density lipoprotein cholesterol divided by triglyceride.</sec_outcome>
      <sec_outcome>Weight, waist and waist to hip. Timepoint: Zero and 12 weeks after intervention. Method of measurement: Measurement with a meter.</sec_outcome>
      <sec_outcome>Systolic and diastolic blood pressure. Timepoint: Zero and 12 weeks after intervention. Method of measurement: By blood pressure monitor device.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-07</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>No. 4, Gharib Ave, Tehran city Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
