<?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>IRCT20130826014477N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-01</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison between the effectiveness of Crocus sativus and Crocin in the treatment of patients with major postpartum depression under common medical care.</public_title>
      <acronym></acronym>
      <scientific_title>Investigation into the effectiveness of Crocus savitus and its active ingredient Crocin as a complementary approach in the treatment of patients with major postpartum depression receiving treatment, using triple blind random clinical trial controlled with placebo, plus assessment of the change in patients' Beck II score.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14102</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple, individual, unstratified randomization using randomization website's random number list and sealed envelope, Blinding description: After all the patients are diagnosed as suffering from postpartum depression by a psychiatrist, they are divided randomly into three groups by an academic individual with knowledge of scientific methods not taking part in the investigation, and their sealed envelope of medications for a period of two weeks and Beck II questionnaire are distributed among the patients by another individual other than the investigator, clinical health care provider and outcome analyst, then the collected data is handed to the investigator.</study_design>
      <phase>3</phase>
      <hc_freetext>major postpartum depression.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Using placebo alongside the patient's main drug regimen. Intervention 2: Second intervention group: Tablets containing five mg Crocin (prepared in the Pharmacy faculty of Mashhad Medical University) taken orally twice a day for three months. Intervention 3: First intervention group: Tablets containing fifteen mg saffron (prepared in the Pharmacy faculty of Mashhad Medical University using Mashhad Saharkhiz company's saffron) taken orally twice a day for three months.</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>Zhila Taherzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of pharmacy, Pardis university campus, Azadi square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91775-1365</zip>
        <telephone>+98 51 1882 3255</telephone>
        <email>taherzadehzh@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zhila Taherzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmacodynamics and Toxicology Group, School of Pharmacy, Medical Science University of Mashhhad, Vakil Abad Blvd, Mashhad</address>
        <city>Mhahhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91775-1365</zip>
        <telephone>+98 51 3882 3255</telephone>
        <email>taherzadehzh@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Nursing mothers after their delivery up to the passage of six months
Nursing mothers in the 18-50 age range
Delivery of full-term, healthy, singleton baby
Acceptance of completion of the informed consent form after providing the necessary information on the investigation
Obtaining of an exact diagnosis of the major depressive disorder using Edinburgh questionnaire by a psychiatrist during a clinical examination</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients with a history of chronic, systemic diseases
Patients with a history of medical disorders such as preeclampsia and diabetes
Patients allergic to saffron
Smoking cigarettes, drinking alcohol and taking drugs
Patients with a history hepatic and renal disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F53.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Severe mental and behavioural disorders associated with the puerperium, not elsewhere classified      Puerperal psychosis NO</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Using placebo alongside the patient's main drug regimen</i_keyword>
      <i_keyword>Second intervention group: Tablets containing five mg Crocin (prepared in the Pharmacy faculty of Mashhad Medical University) taken orally twice a day for three months</i_keyword>
      <i_keyword>First intervention group: Tablets containing fifteen mg saffron (prepared in the Pharmacy faculty of Mashhad Medical University using Mashhad Saharkhiz company's saffron) taken orally twice a day for three months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in mean score of BDI-II. Timepoint: Every two weeks for12 weeks. Method of measurement: BDI_II Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Investigation on alternative medicine on females' sexual function. Timepoint: Beginning of intervention and end of every months. Method of measurement: FSFI Questionnaire.</sec_outcome>
      <sec_outcome>Monitor of, investigation into and finding evidence for completing probable adverse effects of using Corcus Sativus and Crocin in nursing mothers to add to drug's information in herbal pharmacopeia. Timepoint: Beginning of intervention and end of every months during patient's visit for a period of twelve weeks. Method of measurement: Observation and clinical examination of the patient.</sec_outcome>
      <sec_outcome>Examining patients' response to the alternative medicine. Timepoint: At the end of intervention. Method of measurement: Assessment of  patients' number with fifty percent decrease in average score Beck II questionnaire in comparison with the base line.</sec_outcome>
      <sec_outcome>Examining patient's remission under treatment. Timepoint: The end of intervention. Method of measurement: Assessment of  patients' number with seventy percent decrease in average score Beck II questionnaire in comparison with the base line.</sec_outcome>
      <sec_outcome>Assessment of the effects of such interfering factors as age, treatment protocol, type of delivery and etc. Timepoint: The end of intervention. Method of measurement: Statistical analysis of collected data with SPSS software.</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>2018-05-12</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>School of pharmacy, Pardis university campus, Azadi square Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
