<?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>IRCT20130228012654N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-02</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparing the effect of topical Wishca, Diclofenac and Capsaicin cream in knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the therapeutic effect of topical Wishca,Diclofenac and Capsaicin in patient with knee Osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47712</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomztion, a random sequence generated for three treatment groups.
for this purpose, a point in random numbers table was selected and moving to the right, considering single digits, from numbers 1 to 3 assigned to group A: Wishca, numbers 4 to 6 to group B: Cepx and numbers 7 to 9 were assigned to group C: Diclofenac. Based on this sequence, participants entered three treatment groups.
randomization unit: individual.</study_design>
      <phase>N/A</phase>
      <hc_freetext>knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Wishca, patients receiving WishCa herbal cream produced in IMD Company (Dr. Kamkar International Laboratory) contains the active ingredient of 7 herbs; Patients were asked to apply 1 mL of ointment 3 times a day, topically on the osteoarthritic knee. Intervention 2: Intervention group 2: Capsaicin, patients receiving Capex 0.034%, produced by Barijessence inc  ; Patients were asked to apply 1 mL of ointment 3 times a day, topically on the osteoarthritic knee. Intervention 3: Control group: Diclofenac patents receiving Diclofenac Diethylammonium Salt Eq To diclofenac 1% gel produced by RAZAK Labs. Co ; Patients were asked to apply 1 mL of ointment 3 times a day, topically on the osteoarthritic knee.</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 data would be delivered upon  journal request</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Hosseinnezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>00</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9183857838</zip>
        <telephone>00</telephone>
        <email>hosseinnezhad.fatemeh70@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Hosseinnezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>sarab street,   Faculty of Medicine, Mashhad Islamic Azad University</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9183857838</zip>
        <telephone>00</telephone>
        <email>hosseinnezhad.fatemeh70@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>confirmed knee osteoarthritis according to American Rheumatology Association criteria
history of knee pain
ages 30 to 70
knee pain on most days of  &gt;40 mm on a 100 mm VAS on the worst knee
giving informed consent</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patient with other forms of arthritis (including secondary osteoarthritis, Rheumatic diseases
a significant knee injury
Having Low Back Pain and other referral pain to the knee
History of arthroscopy in the previous 6 months,
History of corticosteroid injection in the last 3 months
History of knee surgery
History of the knee clinical trials participation
History of intra-articular injection of hyaluronic acid in the previoHistory of malignancyus 6 months
open knee wound
active dermatitis
Infectious disease involving joints like TB or brucellosis
acute psychological illness (especially depression)
History of malignant neoplasm
history of lower limb trauma leads to rupture of the meniscus, ligament, or capsule
Patients with increased complaints and who are not satisfied with continuing medication</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Wishca, patients receiving WishCa herbal cream produced in IMD Company (Dr. Kamkar International Laboratory) contains the active ingredient of 7 herbs; Patients were asked to apply 1 mL of ointment 3 times a day, topically on the osteoarthritic knee.</i_keyword>
      <i_keyword>Intervention group 2: Capsaicin, patients receiving Capex 0.034%, produced by Barijessence inc  ; Patients were asked to apply 1 mL of ointment 3 times a day, topically on the osteoarthritic knee.</i_keyword>
      <i_keyword>Control group: Diclofenac patents receiving Diclofenac Diethylammonium Salt Eq To diclofenac 1% gel produced by RAZAK Labs. Co ; Patients were asked to apply 1 mL of ointment 3 times a day, topically on the osteoarthritic knee.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Symptoms and function of affected knee. Timepoint: At the baseline, the end of week 1 and 4 with one week washout period. Method of measurement: KOOS questionnaire.</prim_outcome>
      <prim_outcome>Pain. Timepoint: At the baseline, the end of week 1 and 4 with one week washout period. Method of measurement: VAS  visual analogue scale.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: At the baseline, the end of week 1 and 4 with one week washout period. Method of measurement: Angle measurement.</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>Vice Chancellor of Research, Faculty of Medicine, Mashhad Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-23</approval_date>
        <contact_name>Ethics committee of Mashhad Islamic Azad University, Faculty of Medicine</contact_name>
        <contact_address>Sarab street, Shahinfar faculty of medical science Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
