<?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>IRCT20231226060527N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-10-01</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of alphalipoic acid in nausea of ​​pregnancy</public_title>
      <acronym>CEAB6</acronym>
      <scientific_title>Comparing the effect of alipoic acid with vitamin B6 in the treatment of pregnancy nausea and vomiting</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77752</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is based on the formation of Blocks of 4 and the random selection of each of these Blocks for every 4 new Patients entered, and the Blocks are as follows:
AABB                    ABAB                        ABBA
BBAA                     BABA                        BAAB
First, the demographic and clinical information of the patients, including age, BMI, education, gestational age, number of births, type of pregnancy, history of nausea and vomiting during pregnancy will be collected based on the checklist (Appendix 1). Then, using random blocks of 4, the patients will be divided into two groups: 1) alpha lipoic acid and 2) vitamin B6, Blinding description: Due to the fact that the form of the drugs are not the same and the treating physician is one of the evaluators of the results, it is not possible to perform double blinding and the only person who performs the data analysis (data analyzer) will be blinded to the treatment groups. As a result, the study is one-sided blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Pregnancy Nausea and Vomiting.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: vitamin B6 group (recipient of vitamin B6 tablets with a dose of 25 mg orally 3 times a day for one week). Intervention 2: Intervention group: Alpha-lipoic acid group (receiver of alpha-lipoic acid capsules with a dose of 300 mg orally, twice a day for one week).</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shina Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd Floor, No. 8, Nasim Alley, Shebli Blvd.</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618984815</zip>
        <telephone>+98 87 3356 0595</telephone>
        <email>Sh.Karimi.Gyn@Gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shina Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd Floor, No. 8, Nasim Alley, Shebli Blvd.</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618984815</zip>
        <telephone>+98 87 3356 0595</telephone>
        <email>Sh.Karimi.Gyn@Gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gestational age (7 to 14 weeks)
Symptoms of mild to moderate Nausea and Vomiting during Pregnancy with a score of 3 to 12 in the The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) Questionnaire</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Multiple births
PO intolerance
Gestational age below 7 weeks and above 14 weeks
BMI above 35
Taking Anti-vomiting and Anti-nausea Drugs (including Metoclopramide, Ondansetron, Dimenhydranate, etc.) within 48 hours before the visit
Mothers who smoke or use Narcotics
Abnormal pregnancy (molar pregnancy or its history, pregnancy with anomalous or dead fetus, ectopic pregnancy)
Having severe mental disorders
Other Pathologies that cause Nausea and Vomiting in Pregnancy: Gastroenteritis, Gastroparesis, Intestinal obstruction, Bile duct disease, Pancreatitis, Hepatitis, Gastric ulcer, Appendicitis, Pyelonephritis, Ovarian torsion, Urinary tract Stones, Diabetic Ketoacidosis, Patients with previous history Diabetes, uncontrolled gestational diabetes, Blood pressure, Liver dysfunction, Hyperthyroidism, Hyperparathyroidism, Migraine, false brain tumor, Vestibular diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O21.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vomiting of pregnancy, unspecified</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: vitamin B6 group (recipient of vitamin B6 tablets with a dose of 25 mg orally 3 times a day for one week)</i_keyword>
      <i_keyword>Intervention group: Alpha-lipoic acid group (receiver of alpha-lipoic acid capsules with a dose of 300 mg orally, twice a day for one week)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) Questionnaire: the degree of discomfort or Nausea, the number of times of vomiting, the amount of burping in the last 12 hours. Timepoint: At the beginning of the study, 48 hours later, one week later. Method of measurement: The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) Questionnaire.</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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-18</approval_date>
        <contact_name>Ethics committee of Kordestan University of Medical Sciences</contact_name>
        <contact_address>3rd Floor, No. 8, Nasim Alley, Shebli Blvd. Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
