<?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>IRCT20080901001157N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-27</date_registration>
      <primary_sponsor>Iranian academic center for education culture and research</primary_sponsor>
      <public_title>Effect of Nigella sativa oil on knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Effects of oral Nigella sativa seed oil on osteoarthritis indexes in patients suffering from knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29240</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, a random number table and block randomization method is used. In this method, eligible patients are divided into blocks of 4 patients. There is no significant difference between the patients in each block in terms of total pain score index . To half of the patients in a block, from the random numbers table, the numbers whose first digits are even and to other half patients, the numbers that first digit are odd are allocated. Then, half of the patients in the block which the first digit are even the Nigella sativa oil are assigned and the other half of the patients which the first digit are odd are assigned to the placebo, Blinding description: Letters A or B are labeled on drug or placebo emulsion bottles. Other specifications on the labels are completely identical. Physician, nurse, patient, data collector and those who evaluate the outcome, are unaware of the nature and meaning of the letters A or B on the labels. Only the main investigator knows the nature of the labels. Patients are aware that they are either in the drug or in the placebo groups, but they are not aware of the type of group they are in.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Nigella sativa oil emulsion; Patients taking a tablespoon of nigella sativa oil emulsion three times a day after food (5 ml nigella sativa oil daily) for one month. Intervention 2: Placebo group: Placebo emulsion; Patients taking a tablespoon of placebo emulsion three times a day after food ( total 5 ml mineral oil taking per day) for one month.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fallah Huseini Hasan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Institute of Medicinal Plants, ACECR Complex, Supa Boulevard, Poleh Kordan</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3365166571</zip>
        <telephone>+98 26 3476 4010</telephone>
        <email>h.fallah@acecr.ac.ir</email>
        <affiliation>Iranian academic center for education culture and research</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Mohtashami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vanak square, Molasadra Ave, Baqiyatallah University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1484958693</zip>
        <telephone>+98 21 8806 8923</telephone>
        <email>reza_mohtashami1979@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male or female patients with knee osteoarthritis 1 or 2 intensity according to physical examination and knee joint radiography
Age 50 to 70 years
Exacerbation of the disease at a rate of at least 2 units of sub-total pain score after discontinuation of analgesic drugs which was used at least 3 days a week during the last month
A minimum of 9 points out of 20 for pain, joint stiffness and physical activity of the patient according to the criteria of Western Ontario and McMaster Universities pain subscale index after discontinuing analgesic drug medications</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with secondary osteoarthritis due to a known disease
Patients with history of arthroscopy, surgery, knee replacement and injection to the knee joint during the last 6 months
Any serious systemic disease and other chronic inflammatory disease
Patients receiving steroid anti-inflammatory drugs, muscle relaxant, antidepressants, glucosamine, chondroitin, tramadol, topical analgesic agents Like the capsaicin
Alcohol consuming and drug abuse patients
Patients who refuse to stop analgesic drugs
No flares after discontinuation of analgesic drugs that using at least 3 days a week during the last months
Breast-feeding, pregnant women and who intend to have children</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M19.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis, unspecified site</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Nigella sativa oil emulsion; Patients taking a tablespoon of nigella sativa oil emulsion three times a day after food (5 ml nigella sativa oil daily) for one month.</i_keyword>
      <i_keyword>Placebo group: Placebo emulsion; Patients taking a tablespoon of placebo emulsion three times a day after food ( total 5 ml mineral oil taking per day) for one month.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of arthritis. Timepoint: Before and end of intervention after 1 month. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index Questionnaire.</prim_outcome>
      <prim_outcome>Extent of joint pain. Timepoint: Before and end of intervention after 1 month. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index Questionnaire.</prim_outcome>
      <prim_outcome>Extent of joint stiffness. Timepoint: Before and end of intervention after 1 month. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index Questionnaire.</prim_outcome>
      <prim_outcome>Extent of physical function. Timepoint: Before and end of intervention after 1 month. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dose of acetaminophen used. Timepoint: Before intervention and after 1 month at end of the intervention. Method of measurement: Daily recording of the acetaminophen dose used by the patient.</sec_outcome>
      <sec_outcome>Pain intensity. Timepoint: Before and end of the study and after one month. Method of measurement: Visual Analog Scale 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>Iranian academic center for education culture and research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-16</approval_date>
        <contact_name>Ethics committee of Avicenna research institute</contact_name>
        <contact_address>Rashidodin Fazlolah Street, Yaman Ave, Shaheed Chamran Highway, Evin Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
