<?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>IRCT20201010048982N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-04</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of Descurainia sophia (L.) Webb ex prantl on hydration, thirst status, and fatigue in recreational athletes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of Descurainia sophia (L.) Webb ex prantl on hydration, thirst status, and fatigue in recreational athletes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79806</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Eligible samples will be randomly divided into intervention and control groups. The intervention groups will be given codes A, B, C and the control group will receive code D. The study blocking is as follows: All block modes of these 4 groups are 24 numbers: ABCD, ABDC, ACDB, ACBD, ADBC, ADCB, BACD, BADC, BCAD, BCDA, BDAC, BDCA, CABD, CADB, CBAD, CBDA , CDAB, CDBA, DABC, DASB, DBCA, DBAC, DCAB, DCBA. These blocks will be placed in sealed envelopes inside a container. Then they will be drawn one by one, the first block to be removed will be selected as the first block. In fact, this will be repeated 28 times to complete the sample size. In this way, people enter the study and thus will be divided into groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Investigating the state of hydration, thirst and fatigue in non-professional athletes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Non-professional cyclists drank a syrup containing 2 grams of Descurainia sophia powder and 6.25 grams of brown sugar per 100 ml at a temperature of 15 degrees Celsius 30 minutes before the start of the trial and in a controlled environment for 45 minutes with 80% Maximum oxygen consumption run on a treadmill. Intervention 2: Control group: The non-professional cyclist drank 250 ml of sports drink (syrup containing 6.25 g of brown sugar per 100 ml) (placebo) 30 minutes before the start of the test and in controlled environmental conditions for 45 minutes with 80% oxygen. Maximum consumption of running on a treadmill.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
IPD collected for the primary outcome measure only, etc).

When:
starting 6 months after publication

To whom:
The data will be available to researchers working in academic and scientific institutions

Conditions:
After the request of the researchers, and after the publication of the article extracted from this work, the documents will be provided to them

Where to obtain:
Email Dr. Savana Dangyan.
Contact number: 09386658388

How to obtain:
After the request of the researchers, the documents will be provided to them

Comments:
We have no special comment</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sevana Dangian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia University of Medical Sciences, Resalat Blvd., Emergency Room</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5614687911</zip>
        <telephone>+98 45 3333 7906</telephone>
        <email>far.alami28@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sevana danghian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia University of Medical Sciences, Resalat Blvd., Emergency Room</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5614687911</zip>
        <telephone>+98 45 3333 7906</telephone>
        <email>far.alami28@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>- Non-professional cyclists 18-40 years old who volunteered to participate in the study with BMI in the normal range (24/9-18/9)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>- Diagnosis of any systemic disease that may be aggravated by participating in the study
- People with abnormal liver function or abnormal kidney function
- Women who are pregnant or breastfeeding, or intending to become pregnant
- People with blood pressure above 140/90 mmHg or high blood pressure with the use of a diuretic
- People with a history of asthma or allergic disease
- People with a history of alcohol addiction, drug addiction, or mental illness
- People with chronic cardiovascular, metabolic, respiratory diseases, recent muscle and skeletal injuries, previous history of heat stroke during the last 3 years
- People with a history of hay fever allergy based on self-report</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Non-professional cyclists drank a syrup containing 2 grams of Descurainia sophia powder and 6.25 grams of brown sugar per 100 ml at a temperature of 15 degrees Celsius 30 minutes before the start of the trial and in a controlled environment for 45 minutes with 80% Maximum oxygen consumption run on a treadmill.</i_keyword>
      <i_keyword>Control group: The non-professional cyclist drank 250 ml of sports drink (syrup containing 6.25 g of brown sugar per 100 ml) (placebo) 30 minutes before the start of the test and in controlled environmental conditions for 45 minutes with 80% oxygen. Maximum consumption of running on a treadmill.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Thirst evaluation questionnaire will be done at the beginning of the trial and after the end of the study period using the thirst evaluation questionnaire and visual analog scale (VAS) 10 cm self-rating, where zero means no desire to consume liquids and ten means It means extreme thirst.The volunteers' fatigue assessment questionnaire will be completed by the volunteers at the beginning of the trial (minute zero) and after the study period.The volunteers' urine samples will be taken at 0 (before the start of running), 45, 70, 95 and 120 minutes during the trial and will be collected in urine sample containers for analysis. The color and specific density of urine will be measured visually and using a digital refractometer at the mentioned time intervals. Timepoint: The test will be conducted in controlled conditions (temperature 35°C, relative humidity 30% and cooler temperature 26°C) on a treadmill for 45 minutes.Urine samples of volunteers will be taken at 0 (before the start of running), 45, 70, 95 and 120 minutes during the trial and will be collected in urine sample containers for analysis.Volunteers' blood samples will be taken at 0, 45, and 120 minutes during the trial, and blood analyzes will be performed including measurement of plasma volume and hematocrit.The heart rate of the volunteers will be measured at 0, 45, 70, 95 and 120 minutes during the trial period. Thirst evaluation questionnaire at the beginning of the experiment and after the end of the study period will be completed by the volunteers using the thirst evaluation questionnaire and the fatigue evaluation questionnaire of the volunteers at the beginning of the experiment (zero minute) and after the study. Method of measurement: Fatigue and thirst questionnaire, refractometer and blood tests to check the specific density of urine.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-11-21</approval_date>
        <contact_name>Ethics committee of urmia university of medical sciences</contact_name>
        <contact_address>Urmia University of Medical Sciences. Resalat Blvd. Emergency room Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
