<?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>IRCT2015020120895N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-11-08</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effect of an herbal complement on sex hormones in infertile men</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Herbal composition on sex hormones level: a  Single-blinded, comparative controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-01-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18450</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization is provided with a sealed envelope. 
In this method, a number of cards selected by the researcher as the intervention group and the same number of cards for the control group are considered; Then, by merging the cards together (flipping the cards), a card is taken out and its allocation is recorded, and that card is returned to the other cards after being taken out. The cards are then merged again and another card is removed. This process continues until a random sequence is reached according to the sample size, Blinding description: The data collector who evaluates the outcome has no information about the coded packets and their contents and does not know what kind of intervention the intervention group and the control group will receive.</study_design>
      <phase>3</phase>
      <hc_freetext>Male infertility.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group, besides a standard treatment prescribed by an urologist, received two 500 mg capsules containing 350 mg of pollen essence powder and 250 grams of black seed powder every morning and night for three months. Within 90 days, every patient received 180 capsules in sealed coded envelopes. The herbal composition capsules were manufactured by the Golbadistan Company. Intervention 2: The control group received 180 capsules of placebo(500 mg) in the same shape and color as the medicine used in the intervention group besides the standard treatment for 3 months. The placebo was manufactured by Golbadistan Company.</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 As the present clinical trial is currently patented as a new invention, and now the whole process of commercialization is being completed.  Thus  in near future we may publish the findings.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Soghra Fallahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fertility/Infertility Research Center, Ring road, Jomhouri Islami Blvd., Shahid Mohammadi Hospital, Bandar Abbas, Iran.</address>
        <city>Bander-e Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>09173691399</zip>
        <telephone>+98 76 3333 7192</telephone>
        <email>fallahi.leila@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Soghra Fallahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fertility and Infertility Research Center, Shahid Mohammadi Hospital, Kamarbandi St, Jomhuri Eslami Blvd, Bandar Abbas, Hormozgan, Iran</address>
        <city>Bander-e Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919915519</zip>
        <telephone>+98 76 3333 7192</telephone>
        <email>fallahi.leila@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infertile men between 22 and 42 years of age
No allergy to the consumption of herbal medicines
Sperm count less than 20 million per milliliter
morphology &lt; 20%
progressive motility &lt; 50%</inclusion_criteria>
      <agemin>22 years</agemin>
      <agemax>42 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>history of genetic disorder
anomaly in reproductive system
Consumption of fertilizing drugs for at least 6 months before participating in this study
Varicocele
Testicular atrophy
Azospermia
Ejaculation disorder
Candidate for intracytoplasmic injection of sperm
unwillingness to take part in the study
trauma to testicles
alcohol abuse
history of  systemic disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N46.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Oligospermia</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>The intervention group, besides a standard treatment prescribed by an urologist, received two 500 mg capsules containing 350 mg of pollen essence powder and 250 grams of black seed powder every morning and night for three months. Within 90 days, every patient received 180 capsules in sealed coded envelopes. The herbal composition capsules were manufactured by the Golbadistan Company.</i_keyword>
      <i_keyword>The control group received 180 capsules of placebo(500 mg) in the same shape and color as the medicine used in the intervention group besides the standard treatment for 3 months. The placebo was manufactured by Golbadistan Company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sperm Motility. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Determination of sperm motility using CASA  computer system.</prim_outcome>
      <prim_outcome>Sperm count. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Determination of sperm count using CASA computer system.</prim_outcome>
      <prim_outcome>The amount of LH. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Measurement of LH by Radioimmunoassay.</prim_outcome>
      <prim_outcome>The amount of FSH. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Measurement of FSH by radioimmunoassay.</prim_outcome>
      <prim_outcome>The amount of prolactin. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Measurement of prolactin by Radioimmunoassay.</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>Bandare-abbas University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-04</approval_date>
        <contact_name>Ethis ommittee of Bandar Abbas University of Medical Sciences</contact_name>
        <contact_address>Fertility and infertility researh enter,Shahid Mohammadi Hospital,Kamarbandi st., Jomhuri Eslami Blvd., Bandar Abbas, Hormozgan,Iran. Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
