<?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>IRCT20200112046092N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-11</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The efficacy of the traditional medicine preparation of dodder (Cuscuta campestris Yunck.) and polypody (Polypodium vulgare) in patients with obsessive-compulsive disorde</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of the traditional medicine preparation of dodder (Cuscuta campestris Yunck.) and polypody (Polypodium vulgare) in patients with obsessive-compulsive disorder: A double-blind clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45072</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a double-blind clinical trial on patients with obsessive-compulsive disorder in outpatients referring to Kerman psychiatric clinics in 2021-23, Blinding description: This study is a double blind clinical trial. In this study, after patient consent was signed, all patients participating in this study and the clinical researcher were not aware of the type of  medication given to the patient (herbal or placebo).</study_design>
      <phase>3</phase>
      <hc_freetext>Obsessive-compulsive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Herbal drug include Basfaj (Polypodium vulgare) rhizome and aftimon (Cuscuta campestris) The components of the drug are 250 mg tablets (150 mg of Besfaij rhizome powder plus 40 mg of Aftimon aqueous extract, equivalent to 150 mg of Aftimon powder), 55 mg of sucrose and 5 mg of magnesium stearate per tablet). In both groups, fluvoxamine tablets are taken with an average dose of 200 mg daily (100 mg tablets twice a day after meals). In the intervention group, in addition to fluvoxamine tablets, a 250 mg tablet containing the powdered rhizome of Besfaij and Aftimon was received twice a day (in the morning, fasting and at night at bedtime). Intervention 2: Control group:  In this group, the drug used is fluvoxamine tablets with an average dose of 200 mg daily (100 mg tablets) twice a day after meals and placebo tablet. The placebo tablet contains 250 mg of cornstarch powder.</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 data will be available upon request after publication of the article

When:
after publication of the article

To whom:
Researchers working in academic institutions

Conditions:
The request is reviewed on a case-by-case basis

Where to obtain:
Refer to the author's email responsible for the article

How to obtain:
The request will be answered within a maximum of two weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behnaz Bakhshi Nejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jomhuri Eslami Blvd., Faculty of Traditional Iranian Medicine</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618843883</zip>
        <telephone>+98 34 3211 0360</telephone>
        <email>behnaz.bn1984@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behnaz Bakhshi Nejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman, Jomhuri Eslami Blvd., Faculty of Traditional Iranian Medicine</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618843883</zip>
        <telephone>+98 34 3211 0360</telephone>
        <email>behnaz.bn1984@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 18 to 70 years
Practicing obsessive compulsive disorder
Be treated with Fluvoxamine
No alcohol or drugs
Lack of physical illnesses such as: diabetes, hypertension, cardiovascular problems
A score above 21 on the Yale-Brown-OCS criterion
Absence of other psychiatric disorders such as bipolar and psychotic disorders
Absence of mental retardation
Non-pregnancy and lactation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Drug intolerance
Necessity to take psychiatric drugs other than fluvoxamine or to take measures such as ECT</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F42</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obsessive-compulsive disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Herbal drug include Basfaj (Polypodium vulgare) rhizome and aftimon (Cuscuta campestris) The components of the drug are 250 mg tablets (150 mg of Besfaij rhizome powder plus 40 mg of Aftimon aqueous extract, equivalent to 150 mg of Aftimon powder), 55 mg of sucrose and 5 mg of magnesium stearate per tablet). In both groups, fluvoxamine tablets are taken with an average dose of 200 mg daily (100 mg tablets twice a day after meals). In the intervention group, in addition to fluvoxamine tablets, a 250 mg tablet containing the powdered rhizome of Besfaij and Aftimon was received twice a day (in the morning, fasting and at night at bedtime).</i_keyword>
      <i_keyword>Control group:  In this group, the drug used is fluvoxamine tablets with an average dose of 200 mg daily (100 mg tablets) twice a day after meals and placebo tablet. The placebo tablet contains 250 mg of cornstarch powder.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of obsessive symptoms. Timepoint: Before starting the treatment and after 4 and 8 weeks of taking the drug, the participants are asked to complete the Yale-Brown questionnaire. Method of measurement: Yale-Brown questionnaire.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before starting the treatment and after 4 and 8 weeks of taking the drug, the participants are asked to complete the quality of life questionnaire. Method of measurement: quality of life questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Determining the effect of gender on the severity of obsessive symptoms and quality of life in patients with obsessive-compulsive disorders treated with fluvoxamine. Timepoint: Before starting treatment and after 4 to 8 weeks of taking the drug. Method of measurement: WHOQOL-BREF questionnaire and Yale-Brown.</sec_outcome>
      <sec_outcome>Determining the effect of age on the severity of obsessive symptoms and quality of life in patients with obsessive-compulsive disorders treated with fluvoxamine. Timepoint: Before starting treatment and after 4 to 8 weeks of taking the drug. Method of measurement: WHOQOL-BREF questionnaire and Yale-Brown.</sec_outcome>
      <sec_outcome>Determining the effect of education on the severity of obsessive symptoms and quality of life in patients with obsessive-compulsive disorders treated with fluvoxamine. Timepoint: Before starting treatment and after 4 to 8 weeks of taking the drug. Method of measurement: WHOQOL-BREF questionnaire and Yale-Brown.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-27</approval_date>
        <contact_name>Research Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Medical University Campus,Haft-Bagh Highway Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
