<?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>IRCT2016072629084N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-08</date_registration>
      <primary_sponsor>Shahrekord University of Medical Sceinces</primary_sponsor>
      <public_title>The effect of Achillea millefolium and Hypericum perforatum ointments on episiotomy wound healing</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Achillea millefolium and Hypericum perforatum ointments on episiotomy wound healing in primiparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23457</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>episiotomy wound.</hc_freetext>
      <i_freetext>Intervention 1: control group: non-intervention. Intervention 2: control group: consuming placebo ointment. Placebo ointment was Vaseline without extract in 30gr tubes. The patients were selected among women who refferd to shahrekord health centers for routine prenatal visits. Before delivery they received necessary training about how care the sutures, personal hygiene, nutrition and physical activity, then they received one coded ointment and educated how to use: first, the perineum should be washed and dried, then at second day postpartum they were asked to use 1cm of ointment on episiotomy site (the sutures), so that ointment cover all surface of incision, then a pad was used; this was continued twice a day for ten days. Intervention 3: case group: consuming Achillea millefolium ointment. Achillea millefolium purchased from medical plants sellers and after proving the identity by Medical Plants Research Center of Shahrekord University of Medical Sciences, made broken then extracted by using Ethanol %90 solotion. The acquired hydroalcoholic extract condensated untill became dry and this condensated extract packed with strile Vaseline as base (%5 weight ratio) in 30gr tubes.The patients were selected among women who refferd to shahrekord health centers for routine prenatal visits. Before delivery they received necessary training about how care the sutures, personal hygiene, nutrition and physical activity, then they received one coded ointment and educated how to use: first, the perineum should be washed and dried, then at second day postpartum they were asked to use 1cm of ointment on episiotomy site (the sutures), so that ointment cover all surface of incision, then a pad was used; this was continued twice a day for ten days. Intervention 4: case group: consuming Hypericum perforatum ointment. Hypericum perforatum purchased from medical plants sellers and after proving the identity by Medical Plants Research Center of Shahrekord University of Medical Sciences, made broken then extracted by using Ethanol %90 solotion. The acquired hydroalcoholic extract condensated untill became dry and this condensated extract packed with strile Vaseline as base (%5 weight ratio) in 30gr tubes.The patients were selected among women who refferd to shahrekord health centers for routine prenatal visits. Before delivery they received necessary training about how care the sutures, personal hygiene, nutrition and physical activity, then they received one coded ointment and educated how to use: first, the perineum should be washed and dried, then at second day postpartum they were asked to use 1cm of ointment on episiotomy site (the sutures), so that ointment cover all surface of incision, then a pad was used; this was continued twice a day for ten 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh Keivani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashani avenue</address>
        <city>shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>003832251195</telephone>
        <email>ati.keyvani@gmail.com</email>
        <affiliation>Shahrekord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Hajhashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashani avenue</address>
        <city>shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>003833349507</telephone>
        <email>hajhashemy73@yahoo.com</email>
        <affiliation>Shahrekord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
•	Being nulliparous&#13;
•	Gestational age of 37-42 weeks&#13;
•	Having a single fetus&#13;
•	Not to use particular medications (such as glucocorticoids, anticoagulant, chemotherapy, immunosuppressant and radiotherapy)&#13;
•	No history of the diseases that disrupt wound healing process such as chronic systemic diseases, cardiac, renal, pulmonary diseases, coagulation disorders, immune deficiency, connective tissue disorder and diabetes&#13;
•	Not having anemia, mental illnesses, persistent constipation, hemorrhoid, hemophilia and malnutrition&#13;
•	no allergic history of herbal medicines&#13;
•	Body mass index of 19/8-26&#13;
•	having no active skin diseases such as allergic disorders, skin irritation or wound in Incision site and symptomatic vaginitis&#13;
•	Not using antibiotics after episiotomy&#13;
•	no history of perineal repair surgery &#13;
•	no history of genital warts&#13;
Exclusion critera:&#13;
•	Cephalopelvic disproportion in pelvic exam&#13;
•	Disruption in labor progress (first delivery stage &gt; 20hours, and prolonged second delivery stage &gt; 2hours (prolonged labor) or cervical dilation progress ≥ 5cm in hour or labor duration &lt; 3hours (fast Delivery))&#13;
•	Manual placental removal&#13;
•	Third and fourth degree perineal laceration&#13;
•	prolonged membrane Rupture (&gt; 18hours)&#13;
•	abnormal postpartum hemorrhage or hematoma&#13;
•	irregular use of ointment (&lt; 7days or 14 times)&#13;
•	onset complications such as itching or skin irritation</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O90.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disruption of perineal obstetric wound</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_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: non-intervention</i_keyword>
      <i_keyword>control group: consuming placebo ointment. Placebo ointment was Vaseline without extract in 30gr tubes. The patients were selected among women who refferd to shahrekord health centers for routine prenatal visits. Before delivery they received necessary training about how care the sutures, personal hygiene, nutrition and physical activity, then they received one coded ointment and educated how to use: first, the perineum should be washed and dried, then at second day postpartum they were asked to use 1cm of ointment on episiotomy site (the sutures), so that ointment cover all surface of incision, then a pad was used; this was continued twice a day for ten days.</i_keyword>
      <i_keyword>case group: consuming Achillea millefolium ointment. Achillea millefolium purchased from medical plants sellers and after proving the identity by Medical Plants Research Center of Shahrekord University of Medical Sciences, made broken then extracted by using Ethanol %90 solotion. The acquired hydroalcoholic extract condensated untill became dry and this condensated extract packed with strile Vaseline as base (%5 weight ratio) in 30gr tubes.The patients were selected among women who refferd to shahrekord health centers for routine prenatal visits. Before delivery they received necessary training about how care the sutures, personal hygiene, nutrition and physical activity, then they received one coded ointment and educated how to use: first, the perineum should be washed and dried, then at second day postpartum they were asked to use 1cm of ointment on episiotomy site (the sutures), so that ointment cover all surface of incision, then a pad was used; this was continued twice a day for ten days.</i_keyword>
      <i_keyword>case group: consuming Hypericum perforatum ointment. Hypericum perforatum purchased from medical plants sellers and after proving the identity by Medical Plants Research Center of Shahrekord University of Medical Sciences, made broken then extracted by using Ethanol %90 solotion. The acquired hydroalcoholic extract condensated untill became dry and this condensated extract packed with strile Vaseline as base (%5 weight ratio) in 30gr tubes.The patients were selected among women who refferd to shahrekord health centers for routine prenatal visits. Before delivery they received necessary training about how care the sutures, personal hygiene, nutrition and physical activity, then they received one coded ointment and educated how to use: first, the perineum should be washed and dried, then at second day postpartum they were asked to use 1cm of ointment on episiotomy site (the sutures), so that ointment cover all surface of incision, then a pad was used; this was continued twice a day for ten days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain level. Timepoint: Patient explained perineal pain level by a number of 0-10 at second, 7th &amp; 10th &amp; 14th days postpartum. Method of measurement: visual analogue scale.</prim_outcome>
      <prim_outcome>The healing process by 5 specifications: redness, ecchymosis, edema, discharge and wound dehiscence. Timepoint: at 7th, 10th and 14th days after delivery. Method of measurement: researcher assessed redness, edema and ecchymosis in millimeters and charted in perineal repair control form.</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>Shahrekord University of Medical Sceinces</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-08-21</approval_date>
        <contact_name>Ethics committe of Shahrekord University of Medical Sceinces</contact_name>
        <contact_address>Kashani avenue Shahrekord  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
