<?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>IRCT2015010112823N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-19</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology, Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of the Platelet-Rich Plasma(PRP) injection in primary manifestations of knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Effect of the Platelet-Rich Plasma (PRP) injection in primary manifestations of knee osteoarthritis in patients who refer to rheumatology clinic of Kowsar hospital, Semnan</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12827</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>primary manifestations of osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: In the first group (N=30) 3 CC autologous PRP by a syringe which covered in aluminum foil will be intraarticularly injected. The patient is not aware of the contents of the syringe (real injections). Intervention 2: For patients in the control group (n=30) an empty syringe which covered by aluminum foil prepared and its needle enter up to 5 mm into skin and fat tissue without entering into the joint space (Pseudo  injection).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>Introduction:&lt;br /&gt;&#13;
Osteoarthritis (OA) has high prevalence due to various reasons such as occupational and environmental conditions. Pain and discomfort decreased quality of life in patients with osteoarthritis. There is known treatment for the disease. According to the effect of PRP single injection in some reports, in this study we aimed to assess the effect of single injection of platelet-rich plasma(prp) on the symptoms in early stages of knee OA.&lt;br /&gt;&#13;
Patient and methods:&lt;br /&gt;&#13;
In randomized, double-blind, clinical trial 34 patients with early symptoms of knee osteoarthritis in the age range 40-65 years, with a history of chronic knee pain for at least 12 months and kellgren –lawrence radiological criteria were enrolled. Three ml of autologous prp injected in both knees for patients in case group patients and patients in the control group received placebo injected into the another joint. Patients were assessed at baseline and 3 and 6 months after the intervention by IKDC,EQ-VAS,WOMAK and tegner criteria.&lt;br /&gt;&#13;
Result:&lt;br /&gt;&#13;
The difference of the mean IKDC score before and three months after injection as well as three and six months after the injection was statistically significant in the two groups(p=0.040), but was not significant before and six months after injection.&lt;br /&gt;&#13;
Difference of the WOMAC,EQ-VAS and tegner scores were not significant in  the two groups.&lt;br /&gt;&#13;
Conclusion:&lt;br /&gt;&#13;
The results showed that based on the IKDC criteria, single platelet-rich plasma injection can be effective in pain relieving and improve the patients’ performance.&lt;br /&gt;&#13;
           </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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Jamileh Moghimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basidj Boulevard</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 3345 1336</telephone>
        <email>moghimi_jam@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Jamileh Moghimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basidj Boulevard</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 3345 1336</telephone>
        <email>moghimi_jam@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1- age 40-60 years,  2- a history of chronic knee pain for at least 12 months, 3-Kellgren-Lawrence radiological criteria for having developing osteoarthritis of the knee (grade 1 and 2). &#13;
Exclusion criteria: 1. Thrombocytopenia, 2- taking anticoagulant agents during the past 2 weeks 3- taking immunosuppressive drugs, NSAIDs and corticosteroids, 4- liver or renal disease, 5- leukemia and lymphoma, 6- a history of malignancy, active malignant disease, 7- severe cardiovascular disease including congestive heart failure, myocardial infarction and cardiac arrhythmia, 8- bacterial arthritis at least during last 6 months, 9- intra-articular injection of steroid or hyaluronic acid during the last 6 months, 10- use of cigarettes and tobacco 11- fever and systemic infections and local infection in injection site.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Gonarthros</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>M17</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>In the first group (N=30) 3 CC autologous PRP by a syringe which covered in aluminum foil will be intraarticularly injected. The patient is not aware of the contents of the syringe (real injections).</i_keyword>
      <i_keyword>For patients in the control group (n=30) an empty syringe which covered by aluminum foil prepared and its needle enter up to 5 mm into skin and fat tissue without entering into the joint space (Pseudo  injection).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Befor and 3 and 6 months after intervention. Method of measurement: IKDC, EQ-VAS and Tegner criteria.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physical Activities. Timepoint: 6 months after intervantion. Method of measurement: IKDC، EQ-VAS and Tegner criteria.</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>Vice Chancellor for Research and Technology, Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-01-13</approval_date>
        <contact_name>Ethical committee, Semnan university of Medical Sciences</contact_name>
        <contact_address>Basidj Boulevard Semnan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
