<?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>IRCT20190413043264N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-18</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect and safety of Lapis judaicus on kidney stones</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of safety and efficacy of Lapis judaicus versus hydrochlorothiazide in patients with renal stones: a randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39044</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method is block type alog with using random numbers table.
The pharmacist will prepare the three groups of drugs in the same capsule and in the same boxes.The number of boxes is numbered according to the random number and the researcher will randomly give the medicine to patients, Blinding description: Patient, the drug delivery officer, physician and the statistical analyst of the result, will be blind, and only the drug manufacture can decode based on the original from of randomization.</study_design>
      <phase>3</phase>
      <hc_freetext>renal stone.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A:Two capsules containing   Lapis judaicus 1 gram for 2 months . Intervention 2: Intervention group B;  Two capsules containing  Lapis judaicus 1 gram +12.5 mg of hydrochlorothiazide for 2 months. Intervention 3: Control group C: Two capsules containing 12.5 mg of hydrochlorothiazide for 2 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>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 There is not information about it.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Akbarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Traditional Medicine, Shiraz Medical School, Zand Avenue, Shiraz, Iran</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134845794</zip>
        <telephone>+98 71 3234 5145</telephone>
        <email>akbarzadeh_e@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Akbarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical Sciences School, Zand Ave, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134845794</zip>
        <telephone>+98 71 3234 5145</telephone>
        <email>akbarzadeh_e@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have informed and written consent to participate in the study.
Opaque stone greater than  or equal to 5 mm and less than or equal to 10 mm.
Age of 18 to 65 years of both sexes.Male and female.
Satisfaction with the non-use of non-protocol treatments
In one Last month, there was no effective drug on renal stone.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy or lactation
Sensitization  to drugs of intervention
Sensitization to sulfur
Symptoms of digestive, liver or kidney, heart disease ·        ·
Obstruction or other emergency problem during intervention
Dissatisfaction with the patient to continue the plan for both
Organic disease (kidney, liver, heart disease, cancer, diabetes)
Smoking, alcohol and substance abuse
Coagulopathy  disease
Kidney transplant or  single  kidney.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XIV</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>XIV Diseases of the genitourinary system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group A:Two capsules containing   Lapis judaicus 1 gram for 2 months .</i_keyword>
      <i_keyword>Intervention group B;  Two capsules containing  Lapis judaicus 1 gram +12.5 mg of hydrochlorothiazide for 2 months.</i_keyword>
      <i_keyword>Control group C: Two capsules containing 12.5 mg of hydrochlorothiazide for 2 months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Renal stone size. Timepoint: 2 Months. Method of measurement: KUB Sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>BUN. Timepoint: Before and after intervention. Method of measurement: DIRUI Automatic  Analyzer.</sec_outcome>
      <sec_outcome>Cr. Timepoint: Before and after intervention. Method of measurement: DIRUI Automatic  Analyzer.</sec_outcome>
      <sec_outcome>Calcium. Timepoint: Before and after intervention. Method of measurement: DIRUI Automatic  Analyzer.</sec_outcome>
      <sec_outcome>Aspartate Aminotransferase (AST). Timepoint: Before and after intervention. Method of measurement: DIRUI Automatic  Analyzer.</sec_outcome>
      <sec_outcome>Alanine Aminotransferas(ALT). Timepoint: Before and after intervention. Method of measurement: DIRUI Automatic  Analyzer.</sec_outcome>
      <sec_outcome>Urinalysis. Timepoint: Before and after intervention. Method of measurement: refractometry, microscopic and macroscopic  urinalysis.</sec_outcome>
      <sec_outcome>24- hour urine calcium. Timepoint: Before and after intervention. Method of measurement: DIRUI Automatic  Analyzer.</sec_outcome>
      <sec_outcome>24- hour urine magnesium. Timepoint: Before and after intervention. Method of measurement: DIRUI Automatic  Analyzer.</sec_outcome>
      <sec_outcome>24 -Hour urine citrate. Timepoint: Before and after intervention. Method of measurement: DIRUI Automatic  Analyzer.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-05</approval_date>
        <contact_name>Ethics committee of Shiraz University of   Medical Sciences</contact_name>
        <contact_address>University of Medical Science, Zand Ave, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
