<?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>IRCT20211130053228N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-05</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of (Cuminum cyminum,Foeniculum and Anethum graveolens dhi ) capsule  on  a postpartum pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of (Cuminum cyminum,Foeniculum and Anethum graveolens dhi ) capsule  on  a postpartum pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60343</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment method using Excel software, in one of two groups of intervention and control, Blinding description: For blinding, the intervention is performed by the researcher's colleague (midwife with similar work experience) and the researcher is not aware of 
the intervention and control groups. The same and with codes A and B will be prepared and coded by Pharmaco Gnosist consultant. The researcher will not know the codes.</study_design>
      <phase>3</phase>
      <hc_freetext>postpartum pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Herbs (cumin, dill, and fennel) will be purchased and after approving the identification, by soaking in ethanol alcohol at 96 degrees method, they will be extracted. Then the plant extraction (cumin, dill, and fennel) will be mixed with corn starch and filled in 500 mg capsules. Each capsule contains 300 mg prepared extraction from 100 mg of each plant extract. This capsule is prescribed every 8 hours, 2 to 24 hours after normal delivery for mothers who meet the inclusion criteria. The mother will also given mefenamic acid capsule. Intervention 2: Control group: The placebo capsule will be prepared by the Pharmacognosy Research Center of Shahid Beheshti University of Medical Sciences and will be prescribed in the identical dose and capsule in the control group. mother will also given mefenamic acid capsule.</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>Masoome Tajik</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Entrance of Varamin city- Shohada15 Khordad Varamin Hospital</address>
        <city>Varamin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3371461916</zip>
        <telephone>0098 21 35023337-9</telephone>
        <email>massometajik5@gmail.com</email>
        <affiliation>Social Security Organization</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mahboubeh Ahmadi Dolabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali Asr St., Niayesh Intersection, in front of Shahid Rajaei Heart Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>mah1372@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>normal vaginal delivery.
The gestational age  between 37-42 weeks
The live single  neonate with cephalic presentation
The  birth weight  2500-4000 grams.
moderate to severe postpartum  pain based on Visual scale of pain
The placental removal are is spontaneous.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Severe postpartum hemorrhage.
Prolonged  delivery and use vacium.
Analgesia and epidural anesthesia, spinal anesthesia during labor
Addiction
History of systemic diseases
Grade 3 or 4  perineal laceration
History of allergies to medicinal plants</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Herbs (cumin, dill, and fennel) will be purchased and after approving the identification, by soaking in ethanol alcohol at 96 degrees method, they will be extracted. Then the plant extraction (cumin, dill, and fennel) will be mixed with corn starch and filled in 500 mg capsules. Each capsule contains 300 mg prepared extraction from 100 mg of each plant extract. This capsule is prescribed every 8 hours, 2 to 24 hours after normal delivery for mothers who meet the inclusion criteria. The mother will also given mefenamic acid capsule.</i_keyword>
      <i_keyword>Control group: The placebo capsule will be prepared by the Pharmacognosy Research Center of Shahid Beheshti University of Medical Sciences and will be prescribed in the identical dose and capsule in the control group. mother will also given mefenamic acid capsule.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of postpartum pain. Timepoint: 1-2-3-4-5-6-12-18-24 hours  after delivery. Method of measurement: Pain ruler.</prim_outcome>
      <prim_outcome>Duration of pain after   delivery. Timepoint: 1-2-3-4-5-6-12-18-24 hours  after   delivery. Method of measurement: Timer.</prim_outcome>
      <prim_outcome>Time of pain relief after delivery. Timepoint: 1-2-3-4-5-6-12-18-24 hours  after delivery. Method of measurement: Timer.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-01</approval_date>
        <contact_name>Schools of Pharmacy, Nursing and Midwifery - Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Unit 17،Persepolis building،in front of Madani clinic، Shahid Rajaei Street Varamin Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
