<?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>IRCT20220830055831N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-10</date_registration>
      <primary_sponsor>Fasa University of Medical Sciences</primary_sponsor>
      <public_title>The effect of exercise therapy and drug in relieving pain and disability caused by osteoarthritis of the knee</public_title>
      <acronym></acronym>
      <scientific_title>The effect of exercise therapy and drug in relieving pain and disability caused by osteoarthritis of the knee</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65560</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will prepare a sample size of 50 cards, on 25 cards, we will write the letter a and 25 of the rest, and put them in the envelope in the package, and then we ask the patient to select one of the cards at the time of referral. If the patient has an a card, the intervention group and if the owner of the b card is placed in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The intervention group evaluated 25 patients with knee pain by giving me exercise strength, hydrotherapy, aerobic exercise and they are asked to do it 3 times a day for 6 weeks every 10 minutes.This group also use uniflex once a day, wishca cream three times a day and meloxicam tablets 15 mg every 12 hours in case of pain uniflex uniflex tablets containing calcium carbonate, methylsulfonylmethane , vitamin D and K , magnesium and zinc .           Methylsulfonylmethane is anti-inflammatory and antioxidant and has been shown to have cartilage and collagen-making effects, which is useful for our study due to wear, which is cartilage analysis. Intervention 2: Control group: The control group also use uniflex tablets once a day, wishca cream three times a day and meloxicam tablets 15 mg every 12 hours in case of pain, uniflex uniflex tablets containing calcium carbonate, methylsulfonylmethane, vitamin D and K, magnesium and zinc.           Methylsulfonylmethane is anti-inflammatory and antioxidant and has been shown to have cartilage and collagen-making effects, which is useful for our study due to wear, which is cartilage analysis.</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:
Only a portion of data, such as information about the original outcome or the like, can be shared

When:
Start access 6 months after printing the results

To whom:
Academic and Scientific Institutions

Conditions:
Data usage can be used for complementary work and expanding research

Where to obtain:
fateme zeinali 09172516706

How to obtain:
The applicant can access the information after contacting Fatemeh Zeinali

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Zeinali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fars Fasa Phase 1 England Alley I No. 19</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461459331</zip>
        <telephone>+98 917 251 6706</telephone>
        <email>Zeynalif26@gmail.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Zeinali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fars Fasa Phase 1 England Alley I No. 19</address>
        <city>FASa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461459331</zip>
        <telephone>+98 917 251 6706</telephone>
        <email>Zeynalif26@gmail.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age 30 to 70 years
the severity of knee VAS pain above 3</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Knee-related rheumatology such as gout, rheumatological arthritis, RA
No uncontrollable underlying disease
History of knee surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:The intervention group evaluated 25 patients with knee pain by giving me exercise strength, hydrotherapy, aerobic exercise and they are asked to do it 3 times a day for 6 weeks every 10 minutes.This group also use uniflex once a day, wishca cream three times a day and meloxicam tablets 15 mg every 12 hours in case of pain uniflex uniflex tablets containing calcium carbonate, methylsulfonylmethane , vitamin D and K , magnesium and zinc .           Methylsulfonylmethane is anti-inflammatory and antioxidant and has been shown to have cartilage and collagen-making effects, which is useful for our study due to wear, which is cartilage analysis.</i_keyword>
      <i_keyword>Control group: The control group also use uniflex tablets once a day, wishca cream three times a day and meloxicam tablets 15 mg every 12 hours in case of pain, uniflex uniflex tablets containing calcium carbonate, methylsulfonylmethane, vitamin D and K, magnesium and zinc.           Methylsulfonylmethane is anti-inflammatory and antioxidant and has been shown to have cartilage and collagen-making effects, which is useful for our study due to wear, which is cartilage analysis.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score in oswestry Disability index. Timepoint: Evaluation of pain improvement 6 weeks after exercise. Method of measurement: Oswestry Disabylity Index Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient satisfaction score from 0 to 10. Timepoint: Pain score after 6 weeks of exercise. Method of measurement: Patients were asked to tell their satisfaction score from exercises from 0 to 10.</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>Fasa University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-30</approval_date>
        <contact_name>Ethics committee of Fasa University of Medical Sciences</contact_name>
        <contact_address>Ibn Sina Square Fasa Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
