<?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>IRCT2015092413566N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-13</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences-Deputy of Research and Technolog</primary_sponsor>
      <public_title>Effect of  Celery and Anise on oligomenorrhea</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Traditional Iranian Medicine product (based on Celery and Anise seed) with metformin on oligomenorrhea in patients with polycystic ovary syndrome(PCOs)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13384</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Polycystic ovarian syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In the group receiving traditional medicine products,patient will use 4.5 g  celery and anise powder (6 capsules divided into 3 meals ) for two weeks. If the menstruation occurs at each stage of using the drug, the  herbal drug will cut and one placebo capsule will be used after every meal. After purity, restart the herbal medication and this process is repeated 3 cycles. Intervention 2: Control group:In the group  taking metformin,1500 mg metformin powder(6 capsules divided into 3 meals) for two weeks . In the menstruation days and the menstruation waited days,one metformin powder(500mg) capsule will be used.After purity,1500 mg metformin powder(6 capsules divided into 3 meals)repeatedly will be prescribed and this process is repeated 3 cycles.</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>Arezoo Moini Jazani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz.Azadi street.Golgasht street.Tabriz University.in front of the Faculty of Mathematics.upper class of Central Library of Tabriz University of Medical Sciences.School of Traditional Medicine.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166737618</zip>
        <telephone>+98 41 3337 9529</telephone>
        <email>Moeinia@tbzmed.ac.ir                dr.moeeni@yahoo.com</email>
        <affiliation>School of Traditional Medicine-Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Kobra Hamdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz- South Army street-Baghshomal crossroad-Al-Zahra hospital- Infertility ward</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166737618</zip>
        <telephone>+98 41 3553 9161</telephone>
        <email>HamdiK@tbzmed.ac.ir           Hamdi_kobra@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences- Al-Zahra hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients satisfaction , Patients with  PCOS that  their main complaint is oligomenorrhea, age 40-18 years, no pregnancy, no abortion or within 6 weeks post partum; lack of breastfeeding, absence of any systemic diseases such as hyperinsulinemia and hyperandrogenism, diabetes, Cushing's syndrome, congenital adrenal hyperplasia, hyperprolactinemia, thyroid disorders, body mass index between 18 and 35 kg / m2; non-hormonal drugs in the last month, lack of uterine malignancies, ovarian and other malignancies;lack of  Chronic liver disease and kidney failure, lack of headaches and epilepsy; willingness to participate in the study. Exclusion criteria: use of hormonal drugs during the study, the incidence of side effects, the need for other interventions and surgery, pregnancy during the study, patient request for exclusion.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Polycystic ovarian syndrome</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:In the group receiving traditional medicine products,patient will use 4.5 g  celery and anise powder (6 capsules divided into 3 meals ) for two weeks. If the menstruation occurs at each stage of using the drug, the  herbal drug will cut and one placebo capsule will be used after every meal. After purity, restart the herbal medication and this process is repeated 3 cycles.</i_keyword>
      <i_keyword>Control group:In the group  taking metformin,1500 mg metformin powder(6 capsules divided into 3 meals) for two weeks . In the menstruation days and the menstruation waited days,one metformin powder(500mg) capsule will be used.After purity,1500 mg metformin powder(6 capsules divided into 3 meals)repeatedly will be prescribed and this process is repeated 3 cycles.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Experience of menstural bleeding. Timepoint: Before intervention and 1,2, 3, 4 month after intervention. Method of measurement: Ask the patient  and complete tracking form.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of bleeding. Timepoint: Before intervention and 1,2,3, 4 month after intervention. Method of measurement: Ask the patient and complete tracking form.</sec_outcome>
      <sec_outcome>Menstrual blood volume. Timepoint: Before intervention and1,2, 3, 4 month after intervention. Method of measurement: Pictorial Blood Loss Assessment Chart (PBAC).</sec_outcome>
      <sec_outcome>Menstrual cycle length. Timepoint: Before intervention and1,2, 3, 4 month after intervention. Method of measurement: Ask the patient and complete tracking form.</sec_outcome>
      <sec_outcome>Serum LH. Timepoint: Before intervention and 3 month after intervention. Method of measurement: Serum analysis by ELIZA.</sec_outcome>
      <sec_outcome>LH/FSH proportion. Timepoint: Before intervention and 3 month after intervention. Method of measurement: Serum analysis by ELIZA.</sec_outcome>
      <sec_outcome>Free Testosterone. Timepoint: Before intervention and 3 month after intervention. Method of measurement: Serum analysis by ELIZA.</sec_outcome>
      <sec_outcome>Fasting Blood Suger(FBS). Timepoint: Before intervention and 3 month after intervention. Method of measurement: blood biochemistrical analysis.</sec_outcome>
      <sec_outcome>Liver function test(AST,ALT). Timepoint: Before intervention and 3 month after intervention. Method of measurement: spectophotometry.</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>Tabriz University of Medical Sciences-Deputy of Research and Technolog</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-09-14</approval_date>
        <contact_name>Tabriz  University of Medical Sciences- Deputy of research and technology-Ethic committee</contact_name>
        <contact_address>Tabriz-Gogasht street, Tabriz University of Medical Sciences-Central Building number 2-third floor-Deputy of research and technology Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
