<?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>IRCT20230417057944N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-15</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of  Echium Amoenum  on the level of anxiety, perceived stress and occurrence of menstruation</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Aqueous Extract of Echium Amoenum on Anxiety and Perceived Stress and Onset of Menstruation in Women with Menstruation Retard : Three Blind Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>82</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69661</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be non-random (available) and for random allocation of samples to each of the intervention and control groups, permutation blocks of 2 and 4 will be used. The randomization list is generated by the analyst based on the web at the following address (www.sealedenvelope.com), then it is provided to the researcher in sealed and non-transparent envelopes, Blinding description: In this study, the aqueous extract of Echium Amoenum in the form of 500 mg oral capsules and capsules containing corn flour are used as a placebo. The drug and placebo are packed in the same packages in terms of shape and color and are coded with A and B codes, and in this way the study will be blinded from the point of view of the researcher and the research units.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Anxiety. Condition 2: Stress. Condition 3: Oligomenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: People in the intervention group will receive 42 capsules containing the aqueous extract of cow tongue plant in the form of 500 mg oral capsules for 6 weeks (one capsule a day, 30 minutes after breakfast). Gol Elixir Pharmaceutical Company Tos Mashhad will be the drug manufacturer. Intervention 2: :Control group: People in the control group will receive 42 capsules containing corn flour in the form of 500 mg oral capsules for 6 weeks (one capsule a day, 30 minutes after breakfast). Gol Elixir Pharmaceutical Company of Tos Mashhad will be the drug manufacturing 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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sakina Nazeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dastan e Mehr Afarin complex, near to Behesht Qasim Nuqab, Bahar, Nuqab</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>96917-65159</zip>
        <telephone>+98 51 5722 5080</telephone>
        <email>nazerisakina@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 13, 7 Imam Ali Street</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>96917-97852</zip>
        <telephone>+98 51 5722 5080</telephone>
        <email>faribaaskari@yahoo.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women of reproductive age between 18-40 years
Willingness and informed consent to participate in research
Negative pregnancy test
Menstrual cycle delay according to the average period of each person's menstrual cycle in the last six months
History of postponing menstrual bleeding for intervals of 36 days to 6 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Smoking, drugs and alcohol
The existence of underlying medical diseases and disorders related to the reproductive system based on individual statement.
BMI less than 18
Lactation amenorrhea
Suffering from known mental disorders other than stress and anxiety based on the person's statements and scores obtained from the Hamilton Anxiety Rating Scale (HARS) and Cohen's perceived stress questionnaires.
Being allergic to Echium Amoenum
Doing sports professionally
The presence of nutritional disorders such as bulimia nervosa and anorexia nervosa or malnutrition based on the person's statements
Taking hormonal, antihypertensive and depression and herbal medicines
Having primary amenorrhea.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.9</hc_code>
      <hc_code>F43.0</hc_code>
      <hc_code>N91.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
      <hc_keyword>Acute stress reaction</hc_keyword>
      <hc_keyword>Secondary oligomenorrhea</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: People in the intervention group will receive 42 capsules containing the aqueous extract of cow tongue plant in the form of 500 mg oral capsules for 6 weeks (one capsule a day, 30 minutes after breakfast). Gol Elixir Pharmaceutical Company Tos Mashhad will be the drug manufacturer.</i_keyword>
      <i_keyword>:Control group: People in the control group will receive 42 capsules containing corn flour in the form of 500 mg oral capsules for 6 weeks (one capsule a day, 30 minutes after breakfast). Gol Elixir Pharmaceutical Company of Tos Mashhad will be the drug manufacturing company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety mean. Timepoint: At the beginning of the study, 7, 14, 21, 28, 35, 42 days after starting to take the capsule of Echium Amoenum. Method of measurement: Hamilton Anxiety Rating Scale.</prim_outcome>
      <prim_outcome>Perceived Stress mean. Timepoint: At the beginning of the study, 7, 14, 21, 28, 35, 42 days after starting to take the capsule of Echium Amoenum. Method of measurement: Cohen perceived stress scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Occurrence of menstruation in a patient with oligomenorrhea or secondary amenorrhea. Timepoint: 3-7 days after starting to take the capsule of Echium Amoenum, during the period of taking the medicine, 4 weeks after stopping the capsule. Method of measurement: Questionnaire for recording the daily state of menstruation.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-03</approval_date>
        <contact_name>Ethics committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Gonabad University of Medical Sciences, Gonabad, Iran Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
