<?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>IRCT2016121531427N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-25</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of camel milk with Alhagi maurorum Medik on chronic kidney disease</public_title>
      <acronym></acronym>
      <scientific_title>Compare the effects of camel milk with Alhagi maurorum Medik. and current treatments on glomerular filtration rate in patients with chronic kidney disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24722</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization will be done with table of random numbers, Randomization description: Random number table.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Chronic kidney disease, stage 1. Condition 2: Chronic kidney disease, stage 2. Condition 3: Chronic kidney disease, stage 3. Condition 4: Chronic kidney disease, stage 4.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group in addition to routine treatment will receive camel milk a daily dose of 400 ml for three months. Intervention 2: The control group will receive the routine Treatments.</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:
Laboratory information

When:
Six months after printing results

To whom:
Researchers working in academia and academia

Conditions:
Researchers working in academia and academia

Where to obtain:
tavassolyap1@mums.ac.ir

How to obtain:
2 months

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirparviz Tavassoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9184643741</zip>
        <telephone>+98 51 3855 2189</telephone>
        <email>tavassolyap1@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sayyid Musa al-Reza Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qaem Educational, Research and Treatment Center</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9184643741</zip>
        <telephone>+98 51 3855 2189</telephone>
        <email>HoseiniMR@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with chronic kidney disease;
aged 15 to 70 years</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with chronic kidney disease concomitant uncontrolled diabetes(Hb A1c less than 9 and fasting blood sugar greater than 130)
Patients with uncontrolled hypertension(systolic blood pressure of 160 mm Hg and higher and diastolic blood pressure of 100 mm Hg and higher)
cancer patients
patients with urinary obstruction
the fifth stage of chronic kidney disease
patients with acute infection and feverish
patients who are taking nephrotoxic drugs
patients with heart failure
liver failure
poly cystic kidney
pregnancy
patients who had kidney transplant
drug addicts</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.1</hc_code>
      <hc_code>N18.2</hc_code>
      <hc_code>N18.3</hc_code>
      <hc_code>N18.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Kidney damage with normal or increased GFR (&gt; 90 mL/min)</hc_keyword>
      <hc_keyword>Kidney damage with mild decreased GFR (60-89 mL/min)</hc_keyword>
      <hc_keyword>Kidney damage with moderately decreased GFR (30-59 mL/min)</hc_keyword>
      <hc_keyword>Kidney damage with severely decreased GFR (15-29 mL/min)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group in addition to routine treatment will receive camel milk a daily dose of 400 ml for three months.</i_keyword>
      <i_keyword>The control group will receive the routine Treatments</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Glomerular filtration rate. Timepoint: Before the intervention, the end of intervention. Method of measurement: Cockcroft gault Formula, MDRD.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hb. Timepoint: The beginning of the study, the end of the study. Method of measurement: Laboratory blood test.</sec_outcome>
      <sec_outcome>Urinary albumin. Timepoint: The beginning of the study, the end of the study. Method of measurement: Evaluation of urine.</sec_outcome>
      <sec_outcome>24 hour urine protein level. Timepoint: The beginning of the study, the end of the study. Method of measurement: 24 hour urine evaluation.</sec_outcome>
      <sec_outcome>Serum alkaline phosphatase levels. Timepoint: The beginning of the study, the end of the study. Method of measurement: Laboratory blood test.</sec_outcome>
      <sec_outcome>Serum PTH level. Timepoint: The beginning of the study, the end of the study. Method of measurement: Laboratory blood test.</sec_outcome>
      <sec_outcome>Blood uric acid. Timepoint: Before the intervention, the end of intervention. Method of measurement: Laboratory blood test.</sec_outcome>
      <sec_outcome>Serum calcium. Timepoint: The beginning of the study, the end of the study. Method of measurement: Laboratory blood test.</sec_outcome>
      <sec_outcome>Serum sodium. Timepoint: The beginning of the study, the end of the study. Method of measurement: Laboratory blood test.</sec_outcome>
      <sec_outcome>Serum potassium. Timepoint: The beginning of the study, the end of the study. Method of measurement: Laboratory blood test.</sec_outcome>
      <sec_outcome>Serum CRP levels. Timepoint: The beginning of the study, The end of the study. Method of measurement: Laboratory blood test.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: The beginning of the study, the end of the study. Method of measurement: By Sphygmomanometer.</sec_outcome>
      <sec_outcome>FBS. Timepoint: The beginning of the study,Middle of the study, The end of the study. Method of measurement: Laboratory blood test.</sec_outcome>
      <sec_outcome>HbA1C. Timepoint: The beginning of the study, the end of the study. Method of measurement: Laboratory blood test.</sec_outcome>
      <sec_outcome>Lipid profile. Timepoint: The beginning of the study, the end of the study. Method of measurement: Laboratory blood test.</sec_outcome>
      <sec_outcome>Serum creatinine. Timepoint: Before the intervention, the end of intervention. Method of measurement: Evaluation of serum.</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>Vice Chancellor for Research and Technology Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-10</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Technology Mashhad University of Medical Sciences, Building Qureshi, Daneshgah Ave. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
