<?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>IRCT20140902019012N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-27</date_registration>
      <primary_sponsor>School of Iranian Traditional Medicine of Shahid Beheshti University of Medical Science</primary_sponsor>
      <public_title>Comparing the effect of topical ginger oil with oral ginger on the of menstrual flow</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of topical ginger oil with oral ginger on the of menstrual flow</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17111</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization method: Simple randomization
Random unit: Individual
Randomization Tool: Random Numbers
Because the form of the drug is not the same in the two groups, only the person who examines the severity of the symptoms and finally, the analyst of the intervention of the two groups is unaware, Blinding description: The study is a blind side.Because the drug is not the same in the two groups.Only the person who examines the severity of the symptoms and ultimately the analyst is unaware of the intervention of the two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Menorrhagia.</hc_freetext>
      <i_freetext>Intervention 1: Ginger capsule, which is used for treatment and not placebo. Ingredients: Dried rhizome of ginger was prepared as needed to prepare ginger capsules. Each capsule is filled with 250 mg of ginger powder. Intervention 2: Ginger Oil To grind ginger oil, ginger rhizomes are crushed and soaked in sesame oil in a ratio of one (ginger) to five (sesame oil). Then the oil becomes smooth. Microbial control tests include the determination of the total number of aerobic organisms and the absence of Salmonella, Pseudomonas, Staphylococcus and Ecoli.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The questionnaires used and the information about the main outcome after the 3 months of publication of the results are shared with the applicants.

When:
Start the access period 3 months after printing the results

To whom:
Researchers working in institutions academic and scientific

Conditions:
Students doing thesis Research centers

Where to obtain:
pantea shirooye  pshirooye@sbmu.ac.ir Tell: 88773521

How to obtain:
After 6 months of sampling and 2 months of statistical analysis and 3 months after printing results It takes about 14 months to complete. Information is provided to the applicant

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pantea Shirooye</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shams Alley, Vali-e Asr Ave, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14155-6153</zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>pshirooye@sbmu.ac.ir</email>
        <affiliation>School of Traditional Medicine, Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Pantea Shirooye</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shams Alley, Vali-e Asr Ave, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14155-6153</zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>pshirooye@sbmu.ac.ir</email>
        <affiliation>School of Traditional Medicine, Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18 to 45 years
Regular menstruation at intervals of 21 to 35 days and regular bleeding for 3 to 10 days at least in the last three cycles
Do not take other medications
Lack of susceptibility to ginger
No history of hemorrhagic diseases
Lack of history of gallstone</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy
Sensitization during the study
Menstrual disorder; Do not use the medicine properly; Use of another drug not defined in the study
Patients with severe potential side effects; Patients who need surgery and other interventions
Patients who decide to leave the study with a personal request.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N92.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Excessive and frequent menstruation with regular cycle</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>Ginger capsule, which is used for treatment and not placebo. Ingredients: Dried rhizome of ginger was prepared as needed to prepare ginger capsules. Each capsule is filled with 250 mg of ginger powder</i_keyword>
      <i_keyword>Ginger Oil To grind ginger oil, ginger rhizomes are crushed and soaked in sesame oil in a ratio of one (ginger) to five (sesame oil). Then the oil becomes smooth. Microbial control tests include the determination of the total number of aerobic organisms and the absence of Salmonella, Pseudomonas, Staphylococcus and Ecoli.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Menstrual bleeding. Timepoint: cycle before intervention, every cycles during intervention (3 cycles). Method of measurement: PBAC questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effect: Stomachache, nasea, vomiting, hematemesis, belch, fatigue, itching, acne, heartburn, diarrhea, constipation, melena,headache, drowsiness, redness, assessment of bleeding with PBAC. Timepoint: cycle before intervention, every cycle during intervention (3 cycles). Method of measurement: questionnaire.</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>School of Iranian Traditional Medicine of Shahid Beheshti University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-07</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University of Medical Science,Velenjak,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
