<?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>IRCT20161219031463N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-09</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Improving effects of olibanum on learning and memory</public_title>
      <acronym></acronym>
      <scientific_title>Study of adding Boswellia serrata resin to therapy of patients with mild to moderate Alzheimer's disease on cognitive status compared with placebo</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24743</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was done individually, block and using the website www.Randomization.com with 6 subjects per block. This was done by an indipendent researcher and was given to the capsule deliverer by naming the unknown letters that the person did not know the original name of the capsules named in letters, Blinding description: Groups as paticpants, clinical care givers, outcome evaluators and data analyzer are not aware of the presence of samples in the control group of the placebo or the study group. So that the duty of dividing the patients into two groups was performed by the person who was not dependent on the study, and the distribution of the drug and placebo was done by the same person, and until the end of the study, information about the grouping of patients was reserved by this person.</study_design>
      <phase>2</phase>
      <hc_freetext>Alzheimer's disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A capsule containing 750 mg of Olibuma resin is taken orally three times per day for 12 weeks. Capsules are provided by the Pharmacy Department of Herbal Drugs at Imam Reza Pharmacy in Mashhad. Intervention 2: Control group: The placebo is used in the form of capsules are apparently similar to the study drug , which contains 500 mg of starch powder three times a day for 12 weeks orally. Capsules are provided by the pharmacy department of Herbal Drugs at Imam Reza Pharmacy in Mashhad.</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:
Demographic data, MMSE and CDR tests' scores

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

To whom:
Researchers working in academic and scientific institutions

Conditions:
For use in complementary studies including repeat study with higher sample size

Where to obtain:
Dr Hamid Reza Sadeghnia, Mashhad Faculty of Medicine, Department of Pharmacology
Email: Sadeghniahr@mums.ac.ir
Fax: +98 51 3882 8567
Address: Pharmacology Department, Faculty of Medicine, Inside campus college, Azadi square
Postal code: 91388-13944

How to obtain:
Submit a formal and written request from the Research, Academic and Scientific Institute at the address above

Comments:
No comments</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Reza Sadeghnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmacology Department, Faculty of Medicine, Inside campus college, Azadi square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91388-13944</zip>
        <telephone>+98 51 3800 2257</telephone>
        <email>Sadeghniahr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hami Reza Sadeghnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmacology Department, Faculty of Medicine, Inside campus college, Azadi square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91388-13944</zip>
        <telephone>+98 51 3800 2257</telephone>
        <email>Sadeghniahr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with mild to moderate Alzheimer's disease based on the score of the MMSE test between 10-23</inclusion_criteria>
      <agemin>55 years</agemin>
      <agemax>82 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diagnosis of Alzheimer's disease less than 6 months before entering the study
Using cholinesterase inhibitors and / or memantine  less than 90 days before entering the study or discontinuing them less than 90 days before entering the study
Use of other drugs and substances such as ginkgo biloba or vitamin E that affect cognitive status less than 60 days before entering the study or discontinued less than 90 days before entering the study.
Vascular dementia, thyroid disease, vitamin B12 deficiency, anemia, Lewy body dementia, liver function disorders, brain tumors, ischemic cerebrovascular accidents</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dementia in Alzheimer disease</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: A capsule containing 750 mg of Olibuma resin is taken orally three times per day for 12 weeks. Capsules are provided by the Pharmacy Department of Herbal Drugs at Imam Reza Pharmacy in Mashhad</i_keyword>
      <i_keyword>Control group: The placebo is used in the form of capsules are apparently similar to the study drug , which contains 500 mg of starch powder three times a day for 12 weeks orally. Capsules are provided by the pharmacy department of Herbal Drugs at Imam Reza Pharmacy in Mashhad</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive status. Timepoint: Study of cognitive status at the beginning of the study (before the intervention) and 12 weeks after the start of use of capsule containing Olibanum resin or placebo. Method of measurement: Using MMSE and CDR tests.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-18</approval_date>
        <contact_name>The Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Ghershi building, Daneshgah Ave. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
