<?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>IRCT138903252172N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-06-29</date_registration>
      <primary_sponsor>Vice chancellor for reasearch, Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of valerian root extract on sleep disturbances in menopausal women referred to selected health centers affiliated to Iran University of Medical Sciences 1388</public_title>
      <acronym></acronym>
      <scientific_title>Effect of valerian root extract on sleep disturbances in menopausal women referred to selected health centers affiliated to Iran University of Medical Sciences 1388</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1789</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Sleep disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group, Sedamin, 530 mg capsule, twice daily for one month. Intervention 2: Control group, Starch, placebo capsule, twice daily for one month.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>http://www.ncbi.nlm.nih.gov/pubmed/21775910</results_url_link>
      <results_summary>           Abstract&lt;br /&gt;&#13;
OBJECTIVE:&lt;br /&gt;&#13;
Sleep disturbances reduce the quality of life. About 50% of postmenopausal women experience sleep disturbances such as insomnia. Complementary and alternative medical therapies may be useful for the management of sleep disturbances among postmenopausal women. The aim of the present study was to evaluate the effects of valerian extract taken nightly on the improvement of sleep quality in postmenopausal women experiencing insomnia.&lt;br /&gt;&#13;
METHODS:&lt;br /&gt;&#13;
A randomized, triple-blind, controlled trial design was used for this study. Participants consisted of 100 postmenopausal women aged 50 to 60 years who were experiencing insomnia. A demographic data form and the Pittsburgh Sleep Quality Index were used to collect data. The women were randomly divided into two groups. Each group received either 530 mg of concentrated valerian extract or a placebo twice a day for 4 weeks. Descriptive and inferential statistics were used to analyze the data.&lt;br /&gt;&#13;
RESULTS:&lt;br /&gt;&#13;
A statistically significant change was reported in the quality of sleep of the intervention group in comparison with the placebo group (P &lt; 0.001). Also, 30% of the participants in the intervention group and 4% in the placebo group showed an improvement in the quality of sleep (P &lt; 0.001).&lt;br /&gt;&#13;
CONCLUSIONS:&lt;br /&gt;&#13;
Valerian improves the quality of sleep in women with menopause who are experiencing insomnia. Findings from this study add support to the reported effectiveness of valerian in the clinical management of insomnia.&lt;br /&gt;&#13;
</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>Simin Taavoni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd Floor, No.12, Nadjmabady St. Kazeroon St. Mirdamad Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919915375</zip>
        <telephone>00982182471000; 00982182471111</telephone>
        <email>staavoni@iums.ac.ir; staavoni14@yahoo.com</email>
        <affiliation>Nursing and Midwifery Faculty, Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Simin Taavoni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd Floor, No.12, Nadjmabady St. Kazeroon St. Mirdamad Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919915375</zip>
        <telephone>00982182471000; 00982182471111</telephone>
        <email>staavoni14@yahoo.com; staavoni@iums.ac.ir</email>
        <affiliation>Nursing and Midwifery Faculty, Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion and Exclusion criteria: &#13;
• Not having physical and psychological diseases which may cause sleep problems &#13;
• Not to use tobacco, drugs and alcohol &#13;
• Appearance of any physical illness and psychological disorder while in study&#13;
• Significant change in sleep conditions such as travel, shift work, etc. &#13;
• Taking any additional medication during the study &#13;
• Not taking the drug under investigation for more than 7 days during the study</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F51.0, F51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nonorganic sleep disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group, Sedamin, 530 mg capsule, twice daily for one month</i_keyword>
      <i_keyword>Control group, Starch, placebo capsule, twice daily for one month</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep dysfunction score. Timepoint: Before intervention and one month after intervention. Method of measurement: Pittsburg Sleep Quality Index 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>Vice chancellor for reasearch, Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-03-12</approval_date>
        <contact_name>Nursing and Midwifery Faculty, Iran University of Medical Sciences</contact_name>
        <contact_address>Valiasr street, after mirdamad,rashid yasemi street Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
