<?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>IRCT20201130049547N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-06</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>Effects  of Water Enema on Chronic Constipation</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of  Water Enema with common medical therapy in alleviating Constipation in Chronic Constipation patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52789</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be carried out using the “sealed envelope method” . Every participating clinician are provided with an identical set of envelopes which contain either of the two treatment options. Each of the two options have the same in the number in the sets. Each clinician would draw one envelope from the set for each patient and continue the patient’s treatment according to the drawn result.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Constipation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Water Enema recipients Patients will enema 150 to 200 cc of water through the anus daily with Powar. During the 6-month study period, the patient is advised to use only the treatment provided. Intervention 2: Control group: The control group will use the usual treatment for patients with constipation, which includes drug treatment (30 cc of Magnesium Hydroxide syrup every 12 hours and daily Bisacodyl suppository).</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:
All personal data is shared after deleting the profile

When:
Access period starts 9 months after the results are published

To whom:
Researchers working in academic institutions and public and private scientific research centers

Conditions:
Any analysis and use of this data is permitted.

Where to obtain:
dr.rakhsha@yahoo.com

How to obtain:
Obtaining the permit of the deputy of research and technology of North Khorasan University of Medical Sciences.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Rakhsha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. Shahriar6 Ave., Alghadir, Bojnurd,</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9415643344</zip>
        <telephone>+98 912 126 1128</telephone>
        <email>dr.rakhsha@yahoo.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Reza Shoraka</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vector - Borne  Research center- Shahriar St</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>941236542</zip>
        <telephone>+98 58 3229 7182</telephone>
        <email>hamidrezashoraka@yahoo.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All the patients suffering from signs of chronic constipation ( two or fewer defecations in a week )can be included in the study</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>95 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>ME05.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Constipation is an acute or chronic condition in which bowel movements occur less often than usual or consist of hard, dry stools that are often painful or difficult to pass. Here constipation other than specifically described elsewhere such as in here.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Water Enema recipients Patients will enema 150 to 200 cc of water through the anus daily with Powar. During the 6-month study period, the patient is advised to use only the treatment provided.</i_keyword>
      <i_keyword>Control group: The control group will use the usual treatment for patients with constipation, which includes drug treatment (30 cc of Magnesium Hydroxide syrup every 12 hours and daily Bisacodyl suppository).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>An increase in the number of defecations :  more than two defecations  per week. Timepoint: Three months and Six months  after the intervention. Method of measurement: Patients’ Inquiry regarding the number of defecations.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-23</approval_date>
        <contact_name>Ethics committee of North Khorasan University of Medical Sciences</contact_name>
        <contact_address>North Khorasan University of Medical Sciences; Shahriar St; Bojnurd; North Khorasan Province Bojnurd North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
