<?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>IRCT20210202050229N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-02</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>The effect of Cassia fistula syrup  on constipation</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Cassia fistula syrup on quality of life in patients undergoing hemodialysis with constipation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56746</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done using random permutation blocks method. The size of the blocks is 4. Drugs in two categories (drug and placebo) are made by the study pharmacist and sent to the study statistics specialist. The statistician encodes them and places them in blocks of 4 (containing 2 numbers from each group). And is given to the researcher in blind form. Unlock the codes will be done after the end of the study. In case of side effects, the drug code will be unlocked. Blinding is such that placebo syrup and medicine in a single form, with the same label and the same taste and smell will be prepared by a pharmacist in the laboratory of the Clinical Trial Research Center of Shahed University. The only person who knows the nature of syrups is the pharmacist who makes the medicine. To hide the treatment process (Concealment), the drugs in two groups A and B (without explaining its content), reach a statistician and he performs the coding in blocks of four, Blinding description: Blinding is such that placebo syrup and medicine in a single form, with the same label and the same taste and smell will be prepared by a pharmacist in the laboratory of the Clinical Trial Research Center of Shahed University. The only person who knows the nature of syrups is the pharmacist who makes the medicine.</study_design>
      <phase>3</phase>
      <hc_freetext>quality of life.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The drug group is given 10% Cassia fistula  syrup (each 1 ml containing one tenth of a gram of dried pulp of Cassia fistula  fruit) in the amount of 10 ml twice daily for 30 days. Intervention 2: Control group: Placebo syrup is a combination of sugar and honey that turns dark after preparation and heating and is prepared with a dosage defined by the Clinical Trial Research Center of Shahed University.</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 no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>sadegh shirvanifarsani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The end of Abuzar Ghaffari ave , farsan</address>
        <city>farsan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8861868383</zip>
        <telephone>+98 38 3323 4227</telephone>
        <email>sadegh.shirvani1370@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Heidari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Persian Gulf Highway (Tehran - Qom), facing the holy shrine Imam Khomeini, Shahed University</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 2146</telephone>
        <email>mheidari@shahed.ac.ir</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 years and above
Dialysis adequacy index above 1/2
At least 3 months have passed since the start of hemodialysis
Having at least two of the criteria of Rome-3</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Sensitivity to plant compounds, especially Cassia fistula
History of active infection in the last month
Absence of gastrointestinal diseases including irritable bowel syndrome, secondary constipation or neurological diseases (Parkinson's, depression, etc.) Non-neurological diseases (hypothyroidism, hypokalemia, etc.)
History of any gastrointestinal surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: The drug group is given 10% Cassia fistula  syrup (each 1 ml containing one tenth of a gram of dried pulp of Cassia fistula  fruit) in the amount of 10 ml twice daily for 30 days.</i_keyword>
      <i_keyword>Control group: Placebo syrup is a combination of sugar and honey that turns dark after preparation and heating and is prepared with a dosage defined by the Clinical Trial Research Center of Shahed University.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life Score in the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire. Timepoint: Measurement of quality of life before the intervention and 30 days after the start of Cassia fistula syrup. Method of measurement: Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire.</prim_outcome>
      <prim_outcome>Constipation score in the Constipation Assessment Scale (CAS). Timepoint: Measurement of Constipation before the intervention and 30 days after the start of Cassia fistula syrup. Method of measurement: Constipation Assessment Scale (CAS).</prim_outcome>
      <prim_outcome>Frequency and frequency of defecation. Timepoint: Measurement  of the frequency of defecation on a daily basis the start of Cassia fistula syrup. Method of measurement: Make a note in the checklist.</prim_outcome>
      <prim_outcome>Stool consistency in the Bristol stool scale. Timepoint: Measurement  of the stool consistency after each bowel movement after starting Cassia fistula syrup. Method of measurement: Bristol stool scale.</prim_outcome>
      <prim_outcome>Digestive problems. Timepoint: Measurement  of the Digestive problems after each bowel movement after starting Cassia fistula syrup. Method of measurement: Make a note in the checklist.</prim_outcome>
      <prim_outcome>Measurement of blood sodium. Timepoint: Measurement of blood sodium before intervention, two weeks after and four weeks after intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Measurement of blood potassium. Timepoint: Measurement of blood potassium level before the intervention, two weeks after and four weeks after the intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Measurement of blood hemoglobin. Timepoint: Measurement of blood hemoglobin level before the intervention and four weeks after the intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Measurement of blood hematocrit. Timepoint: Measurement of blood hematocrit before intervention and four weeks after intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Blood platelet count. Timepoint: Measurement of blood platelet count before the intervention and four weeks after the intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Measurement of blood urea nitrogen. Timepoint: Measurement of blood urea nitrogen before intervention and four weeks after intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Measurement of blood Creatinine. Timepoint: Measurement of blood Creatinine levels before the intervention and four weeks after the intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Measurement of blood calcium. Timepoint: Measurement of blood calcium levels before the intervention and four weeks after the intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Measurement of blood phosphorus. Timepoint: Measurement of blood phosphorus before the intervention and four weeks after the intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Measurement of blood alkaline phosphatase. Timepoint: Measurement of blood alkaline phosphatase levels before the intervention and four weeks after the intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Blood CRP measurement. Timepoint: Measurement of blood CRP before intervention and four weeks after intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Measurement of PTH in the blood. Timepoint: Measurement of blood PTH before intervention and four weeks after intervention. Method of measurement: blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Itching score in the Itchy Quality of Life (ItchyQoL)  questionnaire. Timepoint: Measurement of pruritus before the intervention and 30 days after the start of Cassia fistula syrup. Method of measurement: Itchy Quality of Life (ItchyQoL) questionnaire.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-31</approval_date>
        <contact_name>Ethics committee of Shahed  University</contact_name>
        <contact_address>Shahed university – Opposite Holy Shrine of Imam Khomeini- Khalij Fars Expressway – Tehran - Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
