<?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>IRCT20200720048144N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-07</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of K-K9 point acupressure and  Quince and Ginger syrup on nausea and vomiting of pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of K-K9 point acupressure and  Quince and Ginger syrup on nausea and vomiting of pregnancy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75497</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Pregnant mothers referring to community health service centers who meet the entry criteria and desired characteristics were selected as available. And after obtaining written informed consent, they will be randomly assigned in two groups, Blinding description: Blinding will be done in such a way that the pregnant mothers participating in the study will be asked not to tell the mothers in the opposite group about the method used to reduce their nausea and vomiting.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Nausea and vomiting of pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Intervention group: In one group, under the supervision of a specialist doctor, Sharbat Beh and Zanjabil Barij essential oil, prepared by Barij Pharmaceutical Company, were given and the amount and method of consumption were taught to the mothers. So that on days 4 to 7, one tablespoon is consumed one hour before each meal. This syrup is a standardized 120 ml container based on 26-22 mg of total phenolics (in terms of gallic acid) per 5 ml of syrup and its ingredients include betel nut, ginger and honey. Intervention 2: Intervention group: Intervention group: In the other group of mothers, from 7 am to 7 pm, every two hours for two minutes on the K-K point 9 (picture no. 1) gentle pressure to the extent that they do not feel uncomfortable and tolerable for 4 days (4 days) to 7) entered. The researcher taught mothers the exact location of the K-K9 point and the amount of pressure on it in a practical way.</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>fateme kameli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>On the side of Asian Road, Gonabad University of Medical Sciences</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 51 5722 5027</telephone>
        <email>kameli.f@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>fateme kameli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>On the side of Asian Road, Gonabad University of Medical Sciences</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 51 5722 5027</telephone>
        <email>kameli.f@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Single pregnancy
maternal age 18-40 years
gestational age less than 20 weeks
nausea with or without Vomiting with mild and moderate severity (score 4-12 based on PUQE-24 questionnaire) of 24</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>high risk pregnancy
illness with nausea and vomiting such as peptic ulcer, hepatitis, pyelonephritis, pancreatitis, cholecystitis, appendicitis, gastroenteritis, urinary tract infection, central nervous system disorders, esophageal reflux disease, hyperthyroidism, mental illness
Known insensitivity to extracts to ginger</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 - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Intervention group: In one group, under the supervision of a specialist doctor, Sharbat Beh and Zanjabil Barij essential oil, prepared by Barij Pharmaceutical Company, were given and the amount and method of consumption were taught to the mothers. So that on days 4 to 7, one tablespoon is consumed one hour before each meal. This syrup is a standardized 120 ml container based on 26-22 mg of total phenolics (in terms of gallic acid) per 5 ml of syrup and its ingredients include betel nut, ginger and honey.</i_keyword>
      <i_keyword>Intervention group: Intervention group: In the other group of mothers, from 7 am to 7 pm, every two hours for two minutes on the K-K point 9 (picture no. 1) gentle pressure to the extent that they do not feel uncomfortable and tolerable for 4 days (4 days) to 7) entered. The researcher taught mothers the exact location of the K-K9 point and the amount of pressure on it in a practical way.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of nausea and vomiting based on PUQE-24 questionnaire. Timepoint: before the start of the intervention and on the 8th day after the start of the intervention. Method of measurement: Questionnaire PUQE-24.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-11</approval_date>
        <contact_name>Ethics Committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Gonabad, near Asian Road, Gonabad University of Medical Sciences gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
