<?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>IRCT2016040627248N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-07-09</date_registration>
      <primary_sponsor>Vice Chancellor for research, School of Traditional medicine, Tehran University of Medical Scienc</primary_sponsor>
      <public_title>Effect of a special food (fried egg with grape molasses) on threatened abortion</public_title>
      <acronym></acronym>
      <scientific_title>The Effects of a Special Food (Fried Eggs with Grape Molasses) on Threatened Miscarriage in Combination with Conventional Therapies: A Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22367</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: None, Randomization description: Blocks of six subjects carried out randomization and treatments’ allocation with using stata software version 13. The list of random allocation of patients will be available only to the epidemiologist.</study_design>
      <phase>3</phase>
      <hc_freetext>Threatened abortion.</hc_freetext>
      <i_freetext>Intervention 1: Control group: They received 400 mg of progesterone suppository (Cyclogest®) with abstinence from sexual intercourse and physical exertion. Progesterone was used daily until two days once the bleeding had stopped. Then up to one week, suppositories were prescribed one day in between. Intervention 2: Intervention group: They received combined medicines: daily Khagineh and daily Cyclogest, abstinence from sexual intercourse, and physical exertion. Khagineh was also consumed daily, up to two days after discontinuation of bleeding/ spotting, and then was continued one day in between, up to one week. "Khagineh Recipe: Beat together one egg and 25 g of grape molasses with salt until blended. Heat 5 g of pasteurized cow butter in a pan until it becomes hot. Pour the blended eggs onto the pan and brown on both sides.".</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>Dr Fatemeh Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614353</zip>
        <telephone>+98 21 6697 6527</telephone>
        <email>dfmoradi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Malieheh Tabarraie Arani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614353</zip>
        <telephone>+98 21 6697 6527</telephone>
        <email>dr.mtabarrai@yahoo.com</email>
        <affiliation>School of Traditional medicine, Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant women presenting with mild to moderate vaginal bleeding (using 2 Pads or less per day)
Up to 16 weeks of pregnancy
Normal ultrasound (including a normal gestational sac at five wk of gestation, yolk sac at six wk, or fetal heart activity at seven wk of gestation or later)
Closed cervix in vaginal examination
Singleton pregnancy
Having consent to participate in the study
Tendency to consume this special food (in intervention group)
No fried eggs with grape molasses in routine diet food</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Mother systemic illness such as fever, diabetes, chronic hypertension
History of recurrent miscarriage
Heavy vaginal bleeding (&gt;2 pads soaked)
Loss of conception tissue
Open cervix (&gt;2 centimeters) in vaginal examination
Cervical lesions such as polyps or cervicitis
Abnormal findings on ultrasound (absence of a normal gestational sac at 5 weeks gestational age, a yolk sac or cardiac activity at 7 weeks gestational age, incomplete abortion, missed abortion)
Multiple gestation sacs
Molar pregnancy
Fetal or uterine anomalies
Allergy or intolerance to eggs, grape molasses or progesterone
The patient withdrew from the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O20.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Haemorrhage specified as due to threatened abortion</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>Control group: They received 400 mg of progesterone suppository (Cyclogest®) with abstinence from sexual intercourse and physical exertion. Progesterone was used daily until two days once the bleeding had stopped. Then up to one week, suppositories were prescribed one day in between.</i_keyword>
      <i_keyword>Intervention group: They received combined medicines: daily Khagineh and daily Cyclogest, abstinence from sexual intercourse, and physical exertion. Khagineh was also consumed daily, up to two days after discontinuation of bleeding/ spotting, and then was continued one day in between, up to one week. "Khagineh Recipe: Beat together one egg and 25 g of grape molasses with salt until blended. Heat 5 g of pasteurized cow butter in a pan until it becomes hot. Pour the blended eggs onto the pan and brown on both sides."</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determine the miscarriage rate (loss of an intrauterine pregnancy at ≤20 week’s gestation) in patients with threatened abortion. Timepoint: Weekly follow-up until vaginal bleeding has been stopped And follow-up at 20 weeks of pregnancy. Method of measurement: Self-designed form.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The average duration of vaginal bleeding. Timepoint: Weekly follow-up until vaginal bleeding has been stopped And follow-up at 20 weeks of pregnancy. Method of measurement: Self-designed form.</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>Vice Chancellor for research, School of Traditional medicine, Tehran University of Medical Scienc</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-12</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
