<?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>IRCT20170510033909N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-29</date_registration>
      <primary_sponsor>Islamic Azad University, Isfahan Branch (Khorasgan), Research Deputy</primary_sponsor>
      <public_title>The effect of supplementation and exercise on indicators of heart damage and oxidative stress in individuals Addicted</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 8 weeks of Royal Jelly supplementation and cache training on cardiac injury indices and oxidative stress in opium addicts quitting methadone</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60459</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: Simple randomization;
Randomization Tool: Random Number Table;
 Randomization Unit: Individual;

In order to use a table of random numbers, the researcher will first determine the reading position of the table numbers.

 The numbers will then be considered for different groups. For example, zero to twenty-four for intervention A, twenty-five to forty-nine for intervention B, fifty to seventy-four for group C, and seventy-five to nine for group D.

Then we will touch one of the numbers and move in one of the predetermined directions. The numbers will be recorded and assigned to four groups: Exercise with cache, use Royal Jelly, combination and control.

In order to hide random allocation, the method of coded boxes with random sequence will be used. This method uses a number of boxes that are numbered randomly. Adequate sealing of the boxes, their apparent similarity and their weight will be ensured.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Addicted.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 : For eight weeks, Royal Jelly was consumed daily as an oral gel at a dose of 100 mg per kilogram of body weight. Intervention 2: Intervention group 2 : Exercise with Cache : Subjects performed resistance exercises using Traband for 8 weeks and 3 consecutive sessions per week for 60 minutes each session. Each workout included 10 minutes of warm-up, 40 minutes of core training, and 10 minutes of cooling. Intervention 3: Intervention group 3 : Exercise with royal jelly supplements Subjects performed resistance exercises using Traband for 8 weeks and 3 consecutive sessions per week for 60 minutes each session. Royal jelly was also consumed daily as a oral gel at a dose of 100 mg per kilogram of body weight. Intervention 4: Control group:  No intervention, only follow up.</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 After the study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Taghian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorasgan University, Arghavanie St, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8183895183</zip>
        <telephone>+98 31335002352</telephone>
        <email>F_taghian@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Taghian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorasgan University, Arghavanie St, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8183895153</zip>
        <telephone>+98 81 8389 5183</telephone>
        <email>F_taghian@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gender
Type of addiction: Opium
Age range 25 to 45 years</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>No heart disease
Not participating in sports in the last year</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F19.20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other psychoactive substance dependence, uncomplicated</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1 : For eight weeks, Royal Jelly was consumed daily as an oral gel at a dose of 100 mg per kilogram of body weight.</i_keyword>
      <i_keyword>Intervention group 2 : Exercise with Cache : Subjects performed resistance exercises using Traband for 8 weeks and 3 consecutive sessions per week for 60 minutes each session. Each workout included 10 minutes of warm-up, 40 minutes of core training, and 10 minutes of cooling</i_keyword>
      <i_keyword>Intervention group 3 : Exercise with royal jelly supplements Subjects performed resistance exercises using Traband for 8 weeks and 3 consecutive sessions per week for 60 minutes each session. Royal jelly was also consumed daily as a oral gel at a dose of 100 mg per kilogram of body weight.</i_keyword>
      <i_keyword>Control group:  No intervention, only follow up</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: Serum concentration of CGRP by ELISA method using the Cayman Chemical Monobind USA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Superoxide dismutase. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: Serum concentration of superoxide dismutase is measured by ELISA method using Ransell kit made by Randox company.</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>Islamic Azad University, Isfahan Branch (Khorasgan), Research Deputy</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-24</approval_date>
        <contact_name>Ethics Committee on Research Islamic Azad University - Isfahan Branch (Khorasgan)</contact_name>
        <contact_address>University Blvd, Arghavanie, East Gay Street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
