<?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>IRCT20190928044906N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-11</date_registration>
      <primary_sponsor>Research deputy of Shahid Beheshti School of Traditional medicine</primary_sponsor>
      <public_title>Effect of persian medicine dietary recommendations in kidney stone</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of Iranian Traditional Medicine (Persian Medicine) dietary recommendations on metabolic risk factors in calcium or radio-opaque kidney stones: a controlled randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42594</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: block randomization. Block randomization with block size of four will be used. Random Allocation software will be used to generate the stochastic sequence. According to the randomly generated sequences, patients enter the control group and the intervention group.</study_design>
      <phase>3</phase>
      <hc_freetext>Diet in nephrolithiasis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Diet based on traditional Iranian medicine books and scientists such as Ibn Sina to control recurrence of stone and improve urinary  supersaturation of calcium oxalate and calcium phosphate and uric acid.  This diet includes orders to Reforming eating etiquette and improve digestion and orders for non-consumption of harmful foods from the viewpoint of Iranian traditional medicine in kidney stone patients  Such as contraindicated yogurt, cheese, and pasta and... etc. Intervention 2: Control group: The diet used in Shahid Labbafinejad Medical Center is based on European and American guidlines to control recurrence of stone and improve urinary  supersaturation of calcium oxalate and calcium phosphate and uric acid. This regime includes orders such as increasing fluid consumption and eating adequate dairy and reducing salt consumption and ...etc.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information of the changes in urinary factors of patients will be available without ability to identify patients

When:
Starting from 2022

To whom:
Researchers working in academic and scientific institutions

Conditions:
Request the article and oral explanations and guidance by email and academic identity

Where to obtain:
Responsible for the research project Dr Reza Ilkhani. ilkhani@sbmu.ac.ir

How to obtain:
After emailing Dr. Ilkhani on his discretion and confirmation of research assistant of Shahid Beheshti Faculty of Traditional Medicine,the information will be available in less than three weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Kargarsharif</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti School of Traditional medicine, No. 8, Shams Alley, Valie Asr Ave, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1516745811</zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>f.kargarsharif@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Ilkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti School of Traditional medicine, No. 8, Shams Alley, Valie Asr Ave, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1516745811</zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>ilkhanir@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Non-pregnant and non-lactating women
Men
Patients referred to the Stone Prevention Clinic of Labbafinejad Hospital which can perform tests and follow-up to implement the plan
People with calcium stone or Patients with Radioopacitis stone in radiology
At least once the recurrence of the stone.
Are not under the special regime to prevent kidney stones, At least 20 days have passed since their last treatment interventions.
18 to 65 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>GFR less than 60
24-hour urinary oxalate above 40 mg Which changed to over 60mg
Taking drugs affecting calcium metabolism such as calcium supplements
Taking oxalate or supresturation modifier drugs like vitamin B6, magnesium, potassium citrate, allopurinol
liver failure diseases, diabetes, hyperthyroid, hyperparathyroid disease, immunopathogenic diseases, cancer, chronic diarrhea, chronic kidney failure and urinary tract infection
Taking anti-obesity drugs to absorb fat-soluble inhibitors such as: Orlistate
Taking herbal medicines less than a month before studying or during the study
Pregnant and lactating women
Added condition: Do not change the dose of blood pressure medication one month before the plan and during the plan</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N20.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Calculus of kidney</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Diet based on traditional Iranian medicine books and scientists such as Ibn Sina to control recurrence of stone and improve urinary  supersaturation of calcium oxalate and calcium phosphate and uric acid.  This diet includes orders to Reforming eating etiquette and improve digestion and orders for non-consumption of harmful foods from the viewpoint of Iranian traditional medicine in kidney stone patients  Such as contraindicated yogurt, cheese, and pasta and... etc.</i_keyword>
      <i_keyword>Control group: The diet used in Shahid Labbafinejad Medical Center is based on European and American guidlines to control recurrence of stone and improve urinary  supersaturation of calcium oxalate and calcium phosphate and uric acid. This regime includes orders such as increasing fluid consumption and eating adequate dairy and reducing salt consumption and ...etc.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>24-hour urinary calcium oxalate supersaturation. Timepoint: The beginning of the study and the end of the two-month diet. Method of measurement: Litorsk Software.</prim_outcome>
      <prim_outcome>24-hour urinary uric acid supersaturation. Timepoint: The beginning of the study and the end of the two-month diet. Method of measurement: Litorsk Software.</prim_outcome>
      <prim_outcome>24-hour urinary calcium phosphate supersaturation. Timepoint: The beginning of the study and the end of the two-month diet. Method of measurement: Litorsk Software.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Evaluate foods eaten (Food recall). Timepoint: The beginning and the end of the study. Method of measurement: Nutrition 4 software.</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>Research deputy of Shahid Beheshti School of Traditional medicine</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-19</approval_date>
        <contact_name>Ethics committee of Shahid beheshti University of Medical Sciences</contact_name>
        <contact_address>7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
