<?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>IRCT20180929041175N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-06</date_registration>
      <primary_sponsor>Shahrood University of Technology</primary_sponsor>
      <public_title>Comparison of wheat Germ Extrat and Flexible Traning on primary Dysmenorrhea of Non- athlete Girls</public_title>
      <acronym>primary dysmenorrheal</acronym>
      <scientific_title>Comparison of wheat Germ Extrat and Flexible Traning on primary Dysmenorrhea of Non- athlete Girls</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34134</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Other design features: This is a randomized trial with pre-test and post-test design with a study group, Randomization description: Sequencing was done using software and by methodologist based on a block size of 8 volumes. Considering the fact that in the present study, four groups were examined (three groups of intervention and one control group) to equalize the sample size In all of the studied groups, 8 blocks were used. So that in each block 8 people were placed. Regarding the sample size, 11 blocks were considered. The random allocation of individuals to the study groups was carried out in such a way that at first 11 envelopes containing 8 cards, labeled with Latin letters AA, BB, CC, DD, of the letters of the letter Wax was used and each random sequence created on a card was recorded and the cards were inserted into the envelope respectively. In order to preserve the random sequence, the envelopes were also numbered on the outer surface and finally the envelopes are pasted, Blinding description: Due to the study nature of the study, there is no possibility for participants to blindness to practice intervention, but the information analyst will not know about how the participants will be present in the groups and they will be educated. The collector does not know the information before the intervention. To fill in the questionnaire after the intervention, another person who is not aware of the group will be used to complete the questionnaire.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Primary Dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group Widow: Wheat germ group: From day 16 of menstrual cycle to five menstruation daily, two capsules of 500 mg capsules consume wheat germ in two consecutive cycles. Capsule, extracts with ethanol 70% in three steps and each stage for 24 hours Done. The resulting extract is then powdered after drying and poured into a 500 mg capsule and each day should consume two capsules several different directions. Intervention 2: Second intervention group (training group): In this study, the subjects performed 8 moves with 3 replicates of 10 seconds for 8 weeks, 4 days a week. Some moves take place in several different directions. Taking these directions in total, 18 moves were performed and each 1 second was added to the stretch. Before and after the training period, all subjects were submucosal flexion (flexion), lumbar (humorous), hamstring (test Sit and brush) and thigh closers (goniometers) are measured and recorded. Intervention 3: Intervention group: Third intervention group: A training group with wheat germ was also operated according to the protocol of the training group and wheat germ. Intervention 4: Control group: During the two-course practice protocol, 500 mg capsules consume the placebo in two consecutive cycles and do not participate in any training program, and only use the relevant questionnaires before and after the training period.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Bolbol haghighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Seventh Tir Square, Shahroud University of Medical Sciences and Health Services</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>36147-73947</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>nbhaghighi349@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Bolbol haghighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haft Tir Square, Shahroud University of Medical Sciences and Health Services</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>36147-73947</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>nbhaghighi349@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female students residing in dormitories aged between 18 and 30 years
Regular menstruation
Not athlete
No history of alcoholic beverages
Not having a history of surgery, especially in the abdomen and pelvis
Healthy and physically and psychologically
History of moderate to severe dysmenorrheal
Not having pelvic diseases</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Absence of more than two sessions during the review period
The history of certain diseases
Gastric ulcer and taking anticoagulants
Irregular menstruation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N80.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endometriosis of uterus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group Widow: Wheat germ group: From day 16 of menstrual cycle to five menstruation daily, two capsules of 500 mg capsules consume wheat germ in two consecutive cycles. Capsule, extracts with ethanol 70% in three steps and each stage for 24 hours Done. The resulting extract is then powdered after drying and poured into a 500 mg capsule and each day should consume two capsules several different directions.</i_keyword>
      <i_keyword>Second intervention group (training group): In this study, the subjects performed 8 moves with 3 replicates of 10 seconds for 8 weeks, 4 days a week. Some moves take place in several different directions. Taking these directions in total, 18 moves were performed and each 1 second was added to the stretch. Before and after the training period, all subjects were submucosal flexion (flexion), lumbar (humorous), hamstring (test Sit and brush) and thigh closers (goniometers) are measured and recorded</i_keyword>
      <i_keyword>Intervention group: Third intervention group: A training group with wheat germ was also operated according to the protocol of the training group and wheat germ.</i_keyword>
      <i_keyword>Control group: During the two-course practice protocol, 500 mg capsules consume the placebo in two consecutive cycles and do not participate in any training program, and only use the relevant questionnaires before and after the training period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Primary dysmenorrhea. Timepoint: 8 Weeks. Method of measurement: Before and after 8 weeks, the questionnaire for systemic symptoms, the mental and emotional symptoms questionnaire, and the visual assessment questionnaire filled the pain or pain intensity.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Motion range (flexibility). Timepoint: 8 Weeks. Method of measurement: Before and after exercises, measure the flexibility of the muscles of the waist and the waist using (ruler), hamstring muscles using (board and brush or flexure board) and thigh closers with (goniometer), height and weight with.</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>Shahrood University of Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-22</approval_date>
        <contact_name>Ethics Committee of Shahrood University of Medical Sciences</contact_name>
        <contact_address>Seventh Tir Square, Shahrood University of Medical Sciences and health services shahrood Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
