<?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>IRCT20190409043220N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-25</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>Comparative study on the effect of honey and olive oil on episiotomy healing</public_title>
      <acronym></acronym>
      <scientific_title>Comparison’s Effects of Honey and Olive Oil on Episiotomy repair in Deliverd Women in Besat Hospital Sanandaj,Year 2019</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>165</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38746</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Honey and olive oil are used as cream with a purity of 30%, Randomization description: Participants with entry criteria are then randomly assigned to three groups using a sealed envelope. A simple randomization method, the individual randomization unit, is the tool for randomizing the packet, Blinding description: The creams will be produced in 3 tubes with the same shape and color,  and will be coded by the pharmacist, and the codes will be provided only to the supervisor, so that the researcher and the research units will be coded Will be aware.</study_design>
      <phase>3</phase>
      <hc_freetext>Episiotomy repair.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The first intervention group is 30 gr. Of honey with a purity of 30%, of which 55 are in this group. Cream is made by the Shafa herbal medicine company in Sanandaj. Intervention in this group starts at 12 hours postpartum. Each person takes one centimeter of worms every 12 hours in the episiotomy for up to 10 days. Intervention 2: Intervention group:The second intervention group is 30 grams of olive oil with a purity of 30%, of which 55 are in this group. Cream is made by the herbal healing plant in Sanandaj. Intervention in this group starts at 12 hours postpartum. Each person takes one centimeter of worms every 12 hours in the episiotomy for up to 10 days. Intervention 3: Control group: The group receives a placebo cream in the same color and shape as the two groups of creams, of which 55 are in this group. Cream is made by the Shafa Herbal Drug Company in Sanandaj. Intervention in this group starts at 12 hours postpartum. Each person takes one centimeter of worms every 12 hours in the episiotomy for up to 10 days.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Khadijeh Seyed Kaboli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Sreet</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>666147 - 13446</zip>
        <telephone>+98 87 3366 4664</telephone>
        <email>Payam_parya@yahoo.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khadijeh Seyed Kaboli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Sreet</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>666147 - 13446</zip>
        <telephone>+98 87 3366 4664</telephone>
        <email>Payam_parya@yahoo.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclination to Participate in the Study
Gestational Age 37- 42 Weeks
Normal Delivery with Mediolateral Episiotomy without Rupture and Tools of 3 to 5 Cm in Length
Live Fetal Embryo with Head View
A Baby Weighing 2500 - 4000 grams</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to Participating in the Study
Use of Forceps and Vacuume During Labor
Use Drugs that Affect the Wound Healing by the Mother
Cure for Diseases Affecting wound Healing
Having a History of Previous Injury or Surgery and visible Lesions in the perineum (Genital Warts, Hemorrhoids) and Persistent Constipation
Rupture of the Water Sac for more than 18 Hours
Mother Abdominal Hemorrhage after childbirth
Exit Manually Placenta
The Presence of perineal Hematoma
Retinal Remodeling after Delivery
Neonatal Admission and Presence of Abnormalitie</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:The first intervention group is 30 gr. Of honey with a purity of 30%, of which 55 are in this group. Cream is made by the Shafa herbal medicine company in Sanandaj. Intervention in this group starts at 12 hours postpartum. Each person takes one centimeter of worms every 12 hours in the episiotomy for up to 10 days.</i_keyword>
      <i_keyword>Intervention group:The second intervention group is 30 grams of olive oil with a purity of 30%, of which 55 are in this group. Cream is made by the herbal healing plant in Sanandaj. Intervention in this group starts at 12 hours postpartum. Each person takes one centimeter of worms every 12 hours in the episiotomy for up to 10 days.</i_keyword>
      <i_keyword>Control group: The group receives a placebo cream in the same color and shape as the two groups of creams, of which 55 are in this group. Cream is made by the Shafa Herbal Drug Company in Sanandaj. Intervention in this group starts at 12 hours postpartum. Each person takes one centimeter of worms every 12 hours in the episiotomy for up to 10 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Episiotomy Repaire. Timepoint: The first 12 hours before the intervention and the 5th and 10th day after the intervention. Method of measurement: Reeda Scale.</prim_outcome>
      <prim_outcome>Episiotomy site pain. Timepoint: The first 12 hours after delivery and before the intervention, on days 5 and 10 after delivery. Method of measurement: Visual Analogue Scale.</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>2019-03-17</approval_date>
        <contact_name>Ethics Committee of Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Pasdaran street Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
