<?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>IRCT20170428033670N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-21</date_registration>
      <primary_sponsor>Immunology Research Center of Shahed University</primary_sponsor>
      <public_title>Effect of Zingiber zerumbet pomade in treatment of knee  arthrosis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Zingiber zerumbet ointment with Diclofenac Gel on clinical symptoms in patients with Knee osteoarthritis: A randomized, double-blind, controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25913</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The allocation of patients to Drug and Positive Control Groups, will be done by block randomization method. Zingiber Zerumbet (ZZ) Ointment and diclofenac gel are packed in completely similar containers and in weight; Each container is identified by a code. The code and contents of containers will be recorded by a third party in a sheet. The drugs are available to the researcher in the binary blocks of ZZ and diclofenac and ultimately distributed among the patients, the investigator and the patient are not aware of the contents of the packages, Blinding description: The drug containers are encoded with the same shape and weight, and are given to the researcher in binary blocks, and then given to the patient;  the patient, the investigator, and the analyst in the study are blinded; The  medications, are indicated for the data analyst as drug A and drug B.</study_design>
      <phase>3</phase>
      <hc_freetext>Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: zingiber zerumbet pomade, Knee local use. Dosage 1 grams per use 4 times a day. Intervention 2: Plus control group: diclofenac gel group. Knee local&#13;
use. Dosage 1 grams per use4 times a day.</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 I currently do not have a specific program to share data, but I will do this in the future.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>hasan kiani Ahmadabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Iranian Traditional Medicine, Shahed University, Persian Gulf Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 4055</telephone>
        <email>hasan-kiani@shahed.ac.ir</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hasan Kiani Ahmadabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Iranian Traditional Medicine, Shahed University, Persian Gulf Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 4055</telephone>
        <email>hasan-kiani@shahed.ac.ir</email>
        <affiliation>Shahed university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Out-patients who suffer osteoarthritis based on clinical criteria of ACR</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Those who need more than 2 grams of acetaminophen daily
Those who need to use other oral or intravenous analgesic
Sensitivity to study drugs
Patients with Secondary osteoarthritis caused by rheumatic diseases such as rheumatoid arthritis
Pregnancy
Joint Replacement
Concomitant use of glucosamine and chondrotin sulfate
Knee corticosteroid injection in the past 3 months
Oral or topical use of Corticosteroid in 14 past days
Other Articular corticosteroid injection in the past 1 months
Mussle corticosteroid injection in the past 1months
Skin Diseases in Knee
Radiculopathy and Neuropathy
Alcohol addicted, Drug Abuse
Patients with active Renal, Liver, and Peptic Ulcer Diseases
Age under 30 or over 80 years</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M19.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Arthrosis, unspecified</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>zingiber zerumbet pomade, Knee local use. Dosage 1 grams per use 4 times a day.</i_keyword>
      <i_keyword>Plus control group: diclofenac gel group. Knee local&#13;
use. Dosage 1 grams per use4 times a day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before the intervention, the end of the second week and the end of the fourth week after the start of the intervention. Method of measurement: The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) questionnaire.</prim_outcome>
      <prim_outcome>Physical Function. Timepoint: Before the intervention, the end of the second week and the end of the fourth week after the start of the intervention. Method of measurement: The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) questionnaire.</prim_outcome>
      <prim_outcome>Stiffness. Timepoint: Before the intervention, the end of the second week and the end of the fourth week after the start of the intervention. Method of measurement: The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Interleukin 1. Timepoint: Before the intervention and the end of the fourth week after the start of the intervention. Method of measurement: Venous blood sample.</sec_outcome>
      <sec_outcome>Interleukin 6. Timepoint: Before the intervention and the end of the fourth week after the start of the intervention. Method of measurement: Venous blood sample.</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>Immunology Research Center of Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-05</approval_date>
        <contact_name>Ethics committee of Shahed University</contact_name>
        <contact_address>Shahed university, Persian gulf freeway, Tehran,iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
