<?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>IRCT20210216050387N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-27</date_registration>
      <primary_sponsor>Fasa University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of  Althaea officinalis ointment in chronic low back pain relief</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the analgesic effects of Topical application  Althaea officinalis ointment and Piroxicam gel in patients with chronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54411</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A 2 groups will be studied and each of the letters A and B will be assigned to an intervention group, 6 possible modes for placing the letters A and B in
will be considered in blocks of 4. 28 blocks of 4 will be considered. For concealment, the type of intervention is written in a random allocation sequence, placed in opaque sealed envelopes and are encoded on the envelopes in order, Blinding description: patients randomly divided into 2 groups of 55 people.One group receives Althaea officinalis ointment and the other group receives Piroxicam gel.The drugs are given to patients in coded containers and without names.This is a double-blind clinical trial (outcome assessor-patients).</study_design>
      <phase>3</phase>
      <hc_freetext>low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 2.5 gr of 20% Althaea officinalis ointment produced in the laboratory of medicinal plants of Fasa University of Medical Sciences used topically twice a day for each person and Acetaminophen 500 mg tablets (manufactured by Zagros darou) once a day for 14 days. Intervention 2: Intervention group: 2 gr of 0.5% Piroxicam gel(manufactured by Razk laboratories), which is used twice a day for each person topically, and Acetaminophen 500 mg tablets(manufactured by Zagros darou) once a day for 14 days.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Leila Nikrouz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Avicenna square, Fasa University of Medical Sciences</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461686688</zip>
        <telephone>+98 71 5335 0994</telephone>
        <email>L.nikrouz@fums.ac.ir</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Leila Nikrouz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Avicenna square, Fasa University of Medical Sciences</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461686688</zip>
        <telephone>+98 71 5335 0994</telephone>
        <email>L.nikrouz@fums.ac.ir</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient informed consent
Doctor's approval
Back pain for more than three months
Pain intensity higher than 3 on the Visual Analogue Scale
Score higher than 4 in the Roland-Morris Disability Questionnaire</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having surgery, fractures, dislocations and sprains in the spine
Diseases such as osteoporosis, osteoarthritis, cancer, rheumatism, disc herniation, sciatica, inflammatory diseases, malignant tumors
Nervous system diseases and spinal cord injuries
Skeletal malformation
Severe structural disorder of the lower limbs and spine
Pregnancy
Injectable analgesics and corticosteroids</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</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: 2.5 gr of 20% Althaea officinalis ointment produced in the laboratory of medicinal plants of Fasa University of Medical Sciences used topically twice a day for each person and Acetaminophen 500 mg tablets (manufactured by Zagros darou) once a day for 14 days.</i_keyword>
      <i_keyword>Intervention group: 2 gr of 0.5% Piroxicam gel(manufactured by Razk laboratories), which is used twice a day for each person topically, and Acetaminophen 500 mg tablets(manufactured by Zagros darou) once a day for 14 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Beginning of the intervention - end of the intervention and 2 weeks after the end of the intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional Disability. Timepoint: Before intervention - end of the intervention. Method of measurement: Roland-Morris Disability Questionnaire.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before intervention - end of the intervention. Method of measurement: Aneroid Sphygmomanometer.</sec_outcome>
      <sec_outcome>Oxygen saturation. Timepoint: Before intervention - end of the intervention. Method of measurement: Finger Pulse Oximeter.</sec_outcome>
      <sec_outcome>Pulse rate. Timepoint: Before intervention - end of the intervention. Method of measurement: Finger Pulse Oximeter.</sec_outcome>
      <sec_outcome>Respiratory rate. Timepoint: Before intervention - end of the intervention. Method of measurement: Stopwatch.</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>2021-03-02</approval_date>
        <contact_name>Ethics committee of Fasa University of Medical Sciences</contact_name>
        <contact_address>Avicenna square, Fasa University of Medical Sciences Fasa Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
