<?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>IRCT20180618040131N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-13</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect Allicin and Silybum Marianum on suindicators of muscle damage</public_title>
      <acronym>CPK,LDH,AST,ALT</acronym>
      <scientific_title>Comparison of the effect a period of consumption Allicin and Silybum Marianum supplementation with four weeks wrestling selective training on some of the indicators of muscle damage in trained wrestlers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>33</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32401</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: First, it is purposeful and selective and then randomly
The methodology will be such that one of the members of the research team (other than the researcher and participants) will be present at the Qom Clubs and will provide names, records, and contact details of all athletes who are active. Then, from among these people, those who have 5 years of history of the wrestling and at least one title at the provincial level competitions will be selected and they will be invited by telephone to attend the club. The wrestlers will be assigned a number if they have criteria for entering the study and have a willingness to participate in the study. Then, by a research member (other than the researcher and participants), using the Random allocation rule, a set of numbers to Group A will be assigned to a group B and a set to the C group.The goal is to prevent any anticipation of future allocations from participants and researchers. For example, in this study with a sample size of 33 people, the balls that has the same weight and shape (33 numbers) are drawn into a container, and each of the letters A, B, C has 11 balls (three groups of letters) placed in the other container. Then, randomly, from each container, a number and a letter are left out of the container without replacement, and the resulting sequence is recorded. Akarca et al. Used this method in their random assignment, Blinding description: Prior to the commencement of the study, supplementary canisters and placebo can be marked by a person other than the researcher so that the knowledge of the researcher and the learners about the type of capsules received is not taken into consideration. The supplement and placebo will be administered under the supervision of the same person (he is a doctor). Which also monitors the subjects.</study_design>
      <phase>4</phase>
      <hc_freetext>Serum markers of muscle injury.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: first, 24 hours after blood sampling, the subjects received 3 tablets 300 mg  containing 1/1 mg of allicin for one month each day made in Isfahan Pharmaceutical Company. Pills will be put in powder form in the capsule. Intervention 2: Intervention group: second, 24 hours after blood sampling, the subjects received 3 tablets containing 140 mg of silybium maryanum for one month each day made in Isfahan Pharmaceutical Company. Pills will be put in powder form in the capsule. Intervention 3: Control group:Third, 24 hours after blood sampling, the subjects received 3 tablets containing Starch. Pills will be put in powder form in the capsule.</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:
Comparison of the effect a period of consumption Allicin and Silybum Marianum supplementation with four weeks wrestling selective training on some of the indicators of muscle damage in trained wrestlers. Due to limited and controversial studies, the possible synergistic effect of these two antioxidants and the lack of access to the studied  on the effects of silymarin and allicin supplementation and sporting activity necessitate that the effect of Allicin and Silybum Marianum supplementation on some of the serum indicators of injury Muscle (Phosphocreatine kinase-lactate dehydrogenase-alanine Aminotransferase- Aspartate aminotransferase) after one month, selected exercises are carried out in male wrestlers who have been practicing. so that coaches and sports technicians can relate to the results  prevent to some extent the occurrence of undesirable signs and symptoms and the cost of double treatment costs.

When:
Next 3 months

To whom:
By giving the resources to all people is allowed.

Conditions:
By giving the resources

Where to obtain:
Email researcher m-sharifian@iau-arak.ac.ir

How to obtain:
Email researcher m-sharifian@iau-arak.ac.ir

Comments:
Doctor will also monitor this study, and capsules, supplements will be provided from the pharmacy.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Sharifian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak- Imam Komeini squar -  Imam Komeini Boulevard – Amir kabir university - Islamic Azad University of Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9131138361</zip>
        <telephone>+98 86 3341 2314</telephone>
        <email>m-sharifian@iau-arak.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Sharifian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nader Mojtamae , 5 Golestan Ave.,Yadegar emam street., Arak Town</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9131138361</zip>
        <telephone>+98 86 3465 5233</telephone>
        <email>m-sharifian@iau-arak.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Wrestlers who have had a continuous training record of at least five years.
At least one championship title has been gained at the provincial level.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>20 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Use of anti-inflammatory drugs and vitamin supplements
Disorders that increase with supplementation of garlic (such as platelet problems, gastritis, hypotension, inflammation of the oral mucosa)</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: first, 24 hours after blood sampling, the subjects received 3 tablets 300 mg  containing 1/1 mg of allicin for one month each day made in Isfahan Pharmaceutical Company. Pills will be put in powder form in the capsule.</i_keyword>
      <i_keyword>Intervention group: second, 24 hours after blood sampling, the subjects received 3 tablets containing 140 mg of silybium maryanum for one month each day made in Isfahan Pharmaceutical Company. Pills will be put in powder form in the capsule.</i_keyword>
      <i_keyword>Control group:Third, 24 hours after blood sampling, the subjects received 3 tablets containing Starch. Pills will be put in powder form in the capsule</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Compare differences in the values of CPK change in different groups. Timepoint: At the beginning of the study (before the intervention) and one month after taking supplements and  exercise ( one hour after training, 24 hours (fasting) and 36 (fasting). Method of measurement: Autoanalyzer selectra l made in poland, centrifuge(hermel z310- germany), The kits and chemicals required will also be supplied by Iran's Pars Test Company.</prim_outcome>
      <prim_outcome>Compare differences in the values of LDH change in different groups. Timepoint: At the beginning of the study (before the intervention) and one month after taking supplements and  exercise ( one hour after training, 24 hours (fasting) and 36 (fasting). Method of measurement: Autoanalyzer selectra l made in poland, centrifuge(hermel z310- germany), The kits and chemicals required will also be supplied by Iran's Pars Test Company.</prim_outcome>
      <prim_outcome>Compare differences in the values of AST change in different groups. Timepoint: At the beginning of the study (before the intervention) and one month after taking supplements and  exercise ( one hour after training, 24 hours (fasting) and 36 (fasting). Method of measurement: Autoanalyzer selectra l made in poland, centrifuge(hermel z310- germany), The kits and chemicals required will also be supplied by Iran's Pars Test Company.</prim_outcome>
      <prim_outcome>Compare differences in the values of ALT change in different groups. Timepoint: At the beginning of the study (before the intervention) and one month after taking supplements and  exercise ( one hour after training, 24 hours (fasting) and 36 (fasting). Method of measurement: Autoanalyzer selectra l made in poland, centrifuge(hermel z310- germany), The kits and chemicals required will also be supplied by Iran's Pars Test Company.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Score Muscle soreness. Timepoint: Measurement of muscular sorness At the beginning of the study (before the intervention) and one month after taking supplements and  exercise ( one hour after training, 24 hours (fasting) and 36 (fasting).supplementation of allicin and silibium marianum. Method of measurement: Borg Pain Questionnaire.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-08</approval_date>
        <contact_name>Institutional Research Ethics Committee Islamic Azad University  Boroujerd-Branch</contact_name>
        <contact_address>Navab Square, Imam Khomeini Complex (Imam Khomeini), Borujerd Town Borujerd Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
