<?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>IRCT20221203056694N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-28</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of platelet-rich plasma therapy in rheumatoid arthritis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Platelet-Rich Plasma (PRP) Therapy with  Steroid Therapy in Improving the Clinical Symptoms of Patients with Rheumatoid Arthritis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67178</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization methods:
The method of simple random assignment is that odd numbers are given to the intervention group (platelet-rich plasma prescription) and even numbers are given to the control group (common treatment with triamcinolone prescription). Then, according to the number of the studied sample, the relevant numbers are extracted from the table of random numbers or using a computer, each number is written on a card and placed in an envelope, and the envelopes are sealed, and the patient's number is written on each envelope. And the first patient who is registered in the study and enters the study will be given the envelope related to patient number 1, patient number 2 will be given envelope number 2 and so on, this work will continue until the end of the study sample. The person who prepares the envelopes will be different from the person who registers the patients and provides the envelopes to the patients. Considering that the treatment allocation of patients is done by the doctor, in order to prevent the influence of the doctor's opinion, the registration of the patients and their allocation in each of the groups will be done by the doctor's assistant and someone other than the doctor, Blinding description: In our study, the investigator, the physician evaluating the treatment, those responsible for data collection, and those evaluating the outcome are blinded.
In this study, in order to avoid applying the personal opinion of the doctor evaluating the course of treatment, he/she will be unaware of the type of treatment received in each of the research subjects, and it is important to note that during the stages of the research, due to the patient's contact with the doctor, blinding will not disappear. Those responsible for data collection should be unaware of the type of treatment received by the people participating in the research. Those who evaluate the results are chosen outside the treatment team so that even if the researcher knows the type of intervention assigned to the participants in the research, their knowledge does not affect the data analysis.</study_design>
      <phase>3</phase>
      <hc_freetext>Rheumatoid arthritis (RA).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Platelet-rich plasma (PRP) therapy uses injections of a concentration of a patient’s own platelets to accelerate the healing of injured tendons, ligaments, and joints. To prepare 4–5 cc PRP, 30–40 cc venous blood samples from the antecubital vein will be collected in a sterile acid citrate dextrose tube using an 18G needle to avoid traumatizing platelets. Then, the blood with anticoagulant will be centrifuged twice: First, we will centrifuge the blood at 1,800 rpm for 15 minutes to separate erythrocytes and Transfer the supernatant plasma containing platelets into another sterile tube (without anticoagulant). Then the tube will be centrifuged at 3,500 rpm for 5 minutes to concentrate platelets. The lower 1/3rd is PRP and the upper 2/3rd is platelet-poor plasma (PPP). PPP will be removed and platelet pellets will be suspended in a minimum quantity of plasma (2-4 mL) by gently shaking the tube. The final product is 4–5 cc of PRP-containing leukocytes. Approximately 0.5 cc PRP will be collected for platelet counting. Finally, 0.0425 mL of 10% calcium chloride per 1 mL of PRP will be added to the final product to activate the platelets.PRP in a sterile condition will be injected by a physician using a classic lateral approach with a 22 G needle with the subjects in a supine position with the knee in full extension. The second injection will be administered under the same conditions as the first injection., three months later. During the follow-up period, the patients will be asked to take acetaminophen only when necessary, or acetaminophen with codeine for persistent pain. The patients will be instructed not to take drugs in the 48 hours before an assessment. Patients will be prohibited from using other analgesics, NSAIDs, steroids, or medications which might have inﬂuenced platelet count or function. Exercise or physical treatment will not be allowed during the study period to eliminate synergistic effects. Patients will be evaluated before the treatment and the 3 months after the treatment with a clinical laboratory exam and radiological examination. A radiological examination of the knee is performed before and at the end of the study. Intervention 2: Control group: Prescribing conventional steroid drugs in the treatment of rheumatoid arthritis. Patients in this group will take intra-articular injections of triamcinolone, 80 mg, at the beginning of the study and three months later.  Frequency of patients’ evaluations: History taking, physical examination {including assessment of VAS (visual analog scale 0-10) for joint pain at rest (VASR), VAS for joint pain at motion (VASM), and VAS for joint swelling (VASSw) at baseline, and months three. Blood sampling will be performed at baseline and in months three. Inflammatory cytokines will be checked at baseline and at the end of the study. Synovial fluid sampling will be performed at each time intra-articular injection. Radiographs will be taken at the baseline and the end of the study.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The participants' data is part of their privacy.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasser Gholijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Autoimmune Diseases Research Center- Shiraz School of Medicine, Imam Hossein Square  Zand St., Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71348-45794</zip>
        <telephone>+98 71 3208 4176</telephone>
        <email>gholijanin@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasser Gholijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Autoimmune Diseases Research Center- Shiraz School of Medicine, Imam Hossein Square  Zand St., Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71348-45794</zip>
        <telephone>+98 71 3208 4176</telephone>
        <email>gholijanin@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>This study will be done on 40 patients with RA diseases who were diagnosed at the rheumatology clinic of Hafez Hospital, according to the American College of Rheumatology/European League Against Rheumatism criteria.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M06</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other rheumatoid arthritis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Platelet-rich plasma (PRP) therapy uses injections of a concentration of a patient’s own platelets to accelerate the healing of injured tendons, ligaments, and joints. To prepare 4–5 cc PRP, 30–40 cc venous blood samples from the antecubital vein will be collected in a sterile acid citrate dextrose tube using an 18G needle to avoid traumatizing platelets. Then, the blood with anticoagulant will be centrifuged twice: First, we will centrifuge the blood at 1,800 rpm for 15 minutes to separate erythrocytes and Transfer the supernatant plasma containing platelets into another sterile tube (without anticoagulant). Then the tube will be centrifuged at 3,500 rpm for 5 minutes to concentrate platelets. The lower 1/3rd is PRP and the upper 2/3rd is platelet-poor plasma (PPP). PPP will be removed and platelet pellets will be suspended in a minimum quantity of plasma (2-4 mL) by gently shaking the tube. The final product is 4–5 cc of PRP-containing leukocytes. Approximately 0.5 cc PRP will be collected for platelet counting. Finally, 0.0425 mL of 10% calcium chloride per 1 mL of PRP will be added to the final product to activate the platelets.PRP in a sterile condition will be injected by a physician using a classic lateral approach with a 22 G needle with the subjects in a supine position with the knee in full extension. The second injection will be administered under the same conditions as the first injection., three months later. During the follow-up period, the patients will be asked to take acetaminophen only when necessary, or acetaminophen with codeine for persistent pain. The patients will be instructed not to take drugs in the 48 hours before an assessment. Patients will be prohibited from using other analgesics, NSAIDs, steroids, or medications which might have inﬂuenced platelet count or function. Exercise or physical treatment will not be allowed during the study period to eliminate synergistic effects. Patients will be evaluated before the treatment and the 3 months after the treatment with a clinical laboratory exam and radiological examination. A radiological examination of the knee is performed before and at the end of the study.</i_keyword>
      <i_keyword>Control group: Prescribing conventional steroid drugs in the treatment of rheumatoid arthritis. Patients in this group will take intra-articular injections of triamcinolone, 80 mg, at the beginning of the study and three months later.  Frequency of patients’ evaluations: History taking, physical examination {including assessment of VAS (visual analog scale 0-10) for joint pain at rest (VASR), VAS for joint pain at motion (VASM), and VAS for joint swelling (VASSw) at baseline, and months three. Blood sampling will be performed at baseline and in months three. Inflammatory cytokines will be checked at baseline and at the end of the study. Synovial fluid sampling will be performed at each time intra-articular injection. Radiographs will be taken at the baseline and the end of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Erythrocyte Sedimentation Rate (ESR). Timepoint: Before and after Platelet-rich plasma (PRP) therapy. Method of measurement: Westergren method.</prim_outcome>
      <prim_outcome>C-reactive protein (CRP). Timepoint: Before and after Platelet-rich plasma (PRP) therapy. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Anti Citrullinated peptide Antibody. Timepoint: Before and after Platelet-rich plasma (PRP) therapy. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Antinuclear Antibody (ANA). Timepoint: Before and after Platelet-rich plasma (PRP) therapy. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Rheumatoid Arthritis (RA) factor. Timepoint: Before and after Platelet-rich plasma (PRP) therapy. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Interleukin-1 beta. Timepoint: Before and after Platelet-rich plasma (PRP) therapy. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Radiological Examination. Timepoint: Before and after Platelet-rich plasma (PRP) therapy. Method of measurement: Radiology.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-25</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz University of Medical Sciences, Zand St., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
