<?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>IRCT20200105046009N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-29</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>The effect of rhubarb (Rheum ribes L.) syrup in Children  with acute diarrhea</public_title>
      <acronym></acronym>
      <scientific_title>The effect of rhubarb (Rheum ribes L.) syrup in Children 1to 6 years with acute diarrhea</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58665</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the random number table, children are divided into two groups: A, rhubarb syrup + standard treatment, and B, control group, which is standard treatment+ placebo syrup. Randomization will be performed using size 4 permutation blocks. In this method, an equal number of drugs (A) and placebo (B) will be placed in each block in random order. This will be done by a statistician, Blinding description: In order to blind the drug and placebo, it will be uniform in color, color and smell and will be prepared in exactly the same packaging and jars.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute diarrhea.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Rhubarb syrup is prepared on the basis of USP 34 (USP simple syrup). USP simple syrup is based on water and sugar 66.7%. The syrup prepared is packaged in 120 ml amber jars with a label. The herbal medicine used in this design is a syrup made from the aqueous extract of R. ribes fruit. Preparation of R. ribes  in the laboratory of medicines Herbal is performed by Shahid Beheshti School of Pharmacy in Tehran. The standard for total flavonoid content is 0.356 MG / ML in syrup. The total flavonoid on Rutin is also 7.13. The desired dose is 2.5 ml for children under 15 kg or 5 ml for children over 15 kg every 6 hours for 5 days. Intervention 2: Control group: placebo is made using a simple formula based on the USP standard of Pharmacoy Syrup, which includes a standard color, flavoring and appearance similar to rhubarb syrup. Finally, both products are placed in the same bottle and in the same packaging. will be provided.</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:
Decide after the end of the study

When:
At the end of the study

To whom:
Academic researchers

Conditions:
Decide after the end of the study

Where to obtain:
email: seyyedali1357@gmail.com

How to obtain:
Ask via email: seyyedali1357@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyed Ali Mozaffarpur</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ganjafruz st.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4717647745</zip>
        <telephone>+98 11 3219 4728</telephone>
        <email>seyyedali1357@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed Ali Mozaffarpur</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ganjafruz ST.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4717647745</zip>
        <telephone>+98 11 3219 4728</telephone>
        <email>seyyedali1357@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children 1 to 6 years
Acute diarrhea (loose stools for more than 3 times a day) in the last 72 hours
Stool white blood cell count less than 5 / HPF in stool with or without mucus or blood
Dehydration mild to moderate</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>More than three days have passed since the onset of diarrhea
Children treated with antibiotics or antidiarrheal drugs in the last 3 days
History of pneumonia, sepsis, meningitis, or toxic colitis during diarrhea
Entamoeba histolytica cyst, Giardia lamblia trophozoite in stool exam
Dysentery (infectious or non-infectious )
Dry milk consumption
Severe malnutrition (weight less than 60% or weight/height less than 70%)
History of known chronic diseases
Any type of food allergy
Use of probiotics
Immunodeficiency
Other infections including urinary tract infections</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Viral and other specified intestinal infections</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: Rhubarb syrup is prepared on the basis of USP 34 (USP simple syrup). USP simple syrup is based on water and sugar 66.7%. The syrup prepared is packaged in 120 ml amber jars with a label. The herbal medicine used in this design is a syrup made from the aqueous extract of R. ribes fruit. Preparation of R. ribes  in the laboratory of medicines Herbal is performed by Shahid Beheshti School of Pharmacy in Tehran. The standard for total flavonoid content is 0.356 MG / ML in syrup. The total flavonoid on Rutin is also 7.13. The desired dose is 2.5 ml for children under 15 kg or 5 ml for children over 15 kg every 6 hours for 5 days.</i_keyword>
      <i_keyword>Control group: placebo is made using a simple formula based on the USP standard of Pharmacoy Syrup, which includes a standard color, flavoring and appearance similar to rhubarb syrup. Finally, both products are placed in the same bottle and in the same packaging. will be provided.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time to recovery. Timepoint: Counting the days of diarrhea up to the normal defecation. Method of measurement: Recovery time from acute diarrhea is defined as the time interval between admission and cessation of diarrhea or the first normal bowel movements, which in the Bristol stool diagram is equivalent to a score below 5.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: Counting the day of hospitalization (the days from hospitalization up to the discharge). Method of measurement: Counting the hospitalization days.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-31</approval_date>
        <contact_name>Ethics Committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Ganjafrooz Street, Babol, Mazandaran, Iran Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
