<?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>IRCT138902263936N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-01-08</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences.</primary_sponsor>
      <public_title>The effect of  red clover on menopausal symptoms</public_title>
      <acronym></acronym>
      <scientific_title>The effects of red clover on some of menopausal symptoms and quality of life in post-menopausal women under coverage of Isfahan’s selected health care center in 2010</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4121</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Other Inclusion criteria:&#13;
 No use of treatments such as hormone therapy, dietary supplementations, herbal therapy in the six months prior to enrollment for relieving menopause symptoms, Interest in participation in the study. &#13;
Other non-inclusion criteria and exclusion:&#13;
The incidence of menopause at the ages under 40 years, Current treatment or therapy in the last 3 months with any of the following drugs: anticonvulsants, antidepressants, phenothiazines, benzodiazepines, ergot derivatives, -blockers, central acting antihypertensive drugs,Vegetarian, Current participation in any other clinical trial, Disorder in the metabolism or sensitivity to estrogen or phytoestrogens (this criterion was assessed with asking the questions about record of using OCPs and incidence of any problem following the consumption of these pills).BMI 25kg/ m2, having any type of disease, Unwillingness to continue participation in the study, Occurrence of any serious event especially one that could affects the quality of life during the study,  Occurrence of any potential complication during the study that could affect the subject's health.&#13;
The data were collected in four phases: at the beginning of the study, at the end of the second, sixth and tenth weeks of study. Before the treatment and at the end of the study, menopause specific quality of life questionnaire (MENQOL) was completed in the two groups. Furthermore, menopausal symptoms weekly were recorded using KMI by the study subjects.&#13;
The subjects were asked to bring the container at the final visit and thus the number of the remained capsules could be counted by one of the health care center’s staff who was not informed about the study process. The study subjects were explained to avoid supplements containing soy more than once a week.&#13;
During the medication consumption, which continued from end of the second week to end of the tenth week, the study subjects recorded their symptoms and were phone called weekly and regular drug consumption was reminded to them. Besides, phone number of the researcher also was given to the study subjects to contact the researcher.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause.</hc_freetext>
      <i_freetext>Intervention 1: Daily oral consumption one 45 mg red clover capsule each morning with the breakfast meal for 8 weeks continued from end of the second week to end of the tenth week. Intervention 2: In the control group: Daily oral consumption one 45 mg starch powder capsule each morning with the breakfast meal for 8 weeks continued from end of the second week to end of the tenth week.</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>Kobra Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical SciencesHazar jarib ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 33 4243 2929</telephone>
        <email>k_salehi@nm.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kobra Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan university of medical sciences-ISFAHAN- IRAN</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 33 4243 2929</telephone>
        <email>k_salehi@nm.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Main Inclusion criteria:&#13;
Age&gt;45 years, Amenorrhea&gt;12 month and&lt;5 year duration, Kupperman Index Score15, Good general health. Able to give informed consent (Able to read and write).&#13;
Main non-inclusion criteria and exclusion:&#13;
Having hormone therapy contraindications, Use of drugs that influence vasomotors symptoms, Occurrence of any serious event in the 6 months prior the study, taking the drugs that might reduce absorption of isoflavones, Consuming less than %80 of the expected capsules during one month.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N95.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Menopausal and female climacteric</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Daily oral consumption one 45 mg red clover capsule each morning with the breakfast meal for 8 weeks continued from end of the second week to end of the tenth week.</i_keyword>
      <i_keyword>In the control group: Daily oral consumption one 45 mg starch powder capsule each morning with the breakfast meal for 8 weeks continued from end of the second week to end of the tenth week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Menopausal symptoms. Timepoint: Before the intervention (treatment), 4 and 8 weeks after beginning the intervention. Method of measurement: Kupperman menopausal index.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the intervention (treatment) and 8 weeks after beginning the intervention. Method of measurement: Menopause -specific quality of life questionnaire.</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>Isfahan University of Medical Sciences.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-05-10</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences- hezargerib st- isfahan -I.R.IRAN Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
