<?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>IRCT20200331046900N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-24</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of oral aloe vera powder on type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the Effect of Oral Aloe Vera Administration on Fasting Plasma Glucose, Lipid Profile, Body Composition Components, Anthropometric Indices, and Blood Pressure Values in Patients with Diabetes Type 2</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46984</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The allocation of participants in two groups of intervention and control is done by the Balanced block randomization method. (Randomization of people between the two groups will be done by blocking method. Thus, the size of the blocks is considered to be 4 and all possible cases are written for groups A and B, and this will be done until the number reaches 60 people.) It is repeated. Then, using a table of random numbers, each of the components of the blocks is given a number. The numbers given to each of the components of the blocks represent the number intended for each person that has already been determined. So the order of the group assigned to each person is specified), Blinding description: Study participants, researchers, and assistants did not know who was in the intervention group and who was in the placebo group. The person who checked the information did not know which group the person belonged to, and the person who delivered the drugs did not know which group was interfering and knew groups 1 and 2. In addition, for weekly follow-ups, the first person was in contact with people who did not know in which group the person was. Participants did not know from the beginning to the end of study which group they were in.</study_design>
      <phase>3</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The raw materials and raw materials required were purchased from Shiraz University of Medical Sciences School of Pharmacy with the advice and approval of a consultant, and then combined under standard conditions and intervened as a supplement. Finally, the capsule contained the main intervention containing 500 mg of aloe vera of the species Barbadensis Aloe prepared by Adonis Gol Daru Company (which was placed in a capsule and patients were advised to take 2 tablets daily for 56 days ( 1 after breakfast and 1 after dinner). Intervention 2: Control group: 500 mg test powder with the advice and approval of a consultant from Shiraz University of Medical Sciences School of Pharmacy in a capsule that was exactly the same in terms of shape, color, smell and size with the capsule containing the main intervention and as a placebo to participants. It is recommended to take 2 tablets daily for 56 days (1 after breakfast and 1 after dinner).</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:
The Excel file contains all the data

When:
Start the access period 6 months after printing the results

To whom:
Data will only be available to researchers working at academic and scientific institutions

Conditions:
Get permission before using the project executor

Where to obtain:
Dr. Siavash Baba Jafari: jafaris@sums.ac.ir
Najmeh Sadat Zareian Jahromi: najmeh.zareayan@gmail.com

How to obtain:
The applicant will introduce himself in an email and explain the reason for the need for data.
  After review, the data will be sent within a week if agreed.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Najmeh Sadat Zareian Jahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karim Khan Zand</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7135848648</zip>
        <telephone>+98 71 9101 1710</telephone>
        <email>najmeh.zareayan@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Siavash Baba Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zahra Alley</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۱۵۳۶۷۵۵۴۱</zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>jafaris@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The desire to participate in the study
Age range 18 to 69 years
Diagnosis of type 2 diabetes by a specialist
The minimum duration of type 2 diabetes is 6 months
Weight constant over the past 6 months ( Self-report )
The type and dose of medications taken have been stable over the past 6 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>69 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Allergy to aloe vera or products containing it
Pregnancy and lactation
Use of any dietary supplement in the last 6 months
Smoking and addiction
Acute heart disease, stroke, liver, kidney, gastrointestinal, thyroid and parathyroid disease, rheumatoid and infectious arthritis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus without complications</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 raw materials and raw materials required were purchased from Shiraz University of Medical Sciences School of Pharmacy with the advice and approval of a consultant, and then combined under standard conditions and intervened as a supplement. Finally, the capsule contained the main intervention containing 500 mg of aloe vera of the species Barbadensis Aloe prepared by Adonis Gol Daru Company (which was placed in a capsule and patients were advised to take 2 tablets daily for 56 days ( 1 after breakfast and 1 after dinner).</i_keyword>
      <i_keyword>Control group: 500 mg test powder with the advice and approval of a consultant from Shiraz University of Medical Sciences School of Pharmacy in a capsule that was exactly the same in terms of shape, color, smell and size with the capsule containing the main intervention and as a placebo to participants. It is recommended to take 2 tablets daily for 56 days (1 after breakfast and 1 after dinner).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total cholesterol. Timepoint: Before the intervention and after the intervention. Method of measurement: Blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: Before and after the intervention. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: Before and after the intervention. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>High-density lipoprotein. Timepoint: Before and after the intervention. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>Low-density lipoprotein. Timepoint: Before and after the intervention. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>Anthropometry. Timepoint: Before and after the intervention. Method of measurement: Scales, meters, calipers and .</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before and after the intervention. Method of measurement: Blood pressure monitor.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-06</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
