<?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>IRCT20220513054837N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-03</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>comparison of curcuma with meloxicam in knee osteoarthritis pain relief</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the efficacy of curcuma drug in comparison with meloxicam on pain relief and functional improvement of patients with knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64562</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: To make the study random, the blocked and cluster random method is used. Patients also in terms of age and the severity of the symptoms of the disease is divided into categories. The list will be prepared by a computer with the same block length and the secretary of the clinic divides patients based on the list, Blinding description: The blinding of the study is that the statistical expert and the questioner will not know the prescribed Medications to patients, but patients will not be blind in this study. For each patient to separately, first the cause and then the stages of research and the drugs used and their side effects will be explained and a written letter of satisfaction is taken.</study_design>
      <phase>3</phase>
      <hc_freetext>knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 1, Treatment in group 1 includes taking 15 mg of meloxicam orally daily for ten days and patients will be taught the method of correcting the way of life and Omeprazole will be prescribed also if needed so they take it fasting. Intervention 2: Intervention group: 2, treatment in group 2 will include two turmeric tablets (curcuma longa ) (turmeric extract) daily for one month, each tablet contains 450 mg of turmeric rhizome powder and 50 mg of turmeric extract and patients will be taught the method of correcting the way of life and Omeprazole will be prescribed also if needed so they take it fasting.</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:
all existing data will be reachable after making people unidentifiable

When:
starting access period one year after publish

To whom:
all personal

Conditions:
if data from this study could help improve sciences trend .

Where to obtain:
alireza karimi 09015613559

How to obtain:
after sending request , a call will be made with cooperative personal and if there are no disagreement , requesting data will be send to them in 4 weeks period .

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Reza Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.13,16 Meter Firestation Ave., Takhtjamshid Crossroad, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71577-63434</zip>
        <telephone>+98 71 3720 9719</telephone>
        <email>dralirezakarimi1988@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Reza Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.13,16 Meter Firestation Ave., Takhtjamshid Crossroad, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71577-63434</zip>
        <telephone>+98 71 3720 9719</telephone>
        <email>dralirezakarimi1988@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>completing and signing a consent form
having symptoms of knee osteoarthritis in at least one recent month
age between 40 and 60
lack of the presence of any other disease around the affected limb</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>having diabetes
having diseases such as Rheumatism, gout, collagen vascular and lupus
having accompanying radiculopathy
history of trauma, fracture and injury to the affected joint, nerve damage and neuropathies
history of knee replacement on the affected side
history of allergies to drugs used in the study
history of significant heart, kidney, liver and lung disorders
pregnant and lactating women
BMI above 42
having brucellosis
history of injection in the affected joint or in addition in the last 3 months
inability to communicating and completing questionnaires
patients taking anticoagulants
cancer patients
history or gastrointestinal disorders and stomach problems
consuming warfarin and ticlopidine and aspirin
uncontrolled hypertension
very severe osteoarthritis of the knee based on radiology</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M19.90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified osteoarthritis, unspecified site</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>Intervention group: 1, Treatment in group 1 includes taking 15 mg of meloxicam orally daily for ten days and patients will be taught the method of correcting the way of life and Omeprazole will be prescribed also if needed so they take it fasting.</i_keyword>
      <i_keyword>Intervention group: 2, treatment in group 2 will include two turmeric tablets (curcuma longa ) (turmeric extract) daily for one month, each tablet contains 450 mg of turmeric rhizome powder and 50 mg of turmeric extract and patients will be taught the method of correcting the way of life and Omeprazole will be prescribed also if needed so they take it fasting.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain rate based on the score obtained from the Visual Analog Scale questionnaire in the study. Timepoint: before and after starting treatment in second , forth and fifth weeks. Method of measurement: Filling in the questionnaire VAS by the patient and reading the questionnaire information.</prim_outcome>
      <prim_outcome>Knee disability based on the score obtained from the Oxford knee Scale in the study. Timepoint: before and after starting treatment in second , forth and fifth weeks. Method of measurement: Filling in the questionnaire OKS by the patient and reading the questionnaire information.</prim_outcome>
      <prim_outcome>Morning stiffness based on the score obtained from the Western Ontario and McMaster Universities Arthritis Index in the study. Timepoint: before and after starting treatment in second , forth and fifth weeks. Method of measurement: Filling in the questionnaire WOMAC by the patient and reading the questionnaire information.</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>2022-05-23</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>No.13, 16 meter Fire station Ave.,tatkt jamshid cross road, Aboonasr Blvd., Shiraz Town Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
