<?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>IRCT20210806052093N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-16</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The effect of kharatin oil on improving limb stiffness in patients with neurological disorders</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of application of kharatin oil on the improvement of spasticity of patients with neurological disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58070</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: The participant is blind.The drug and placebo are randomly distributed and recorded among the participants without a label and in identical envelopes by the project partner.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Tropical spastic paraplegia. Condition 2: Spastic hemiplegia. Condition 3: Multiple sclerosis. Condition 4: Neuromyelitis optica. Condition 5: Hypoxic ischemic encephalopathy. Condition 6: Spondylolysis cervical.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:25 people in the intervention group who have spasticity disorder are treated topically with standard Aral kharatin oil made in Iran for 3 months. First, the limb with spasticity is washed with soap and water to be completely clean, and after washing, gently Massage the desired limb for 10 minutes until the skin color turns red to some extent. Then pour a few drops of kharatin oil on the limb and start a gentle massage until the oil is completely absorbed by the skin. Massage time is at least 5 minutes and up to 10 minutes. And twice a day. At least an hour after that, the oil should remain on the skin and not be washed. Intervention 2: Control group: 25 people in the control group who have spasticity disorder are treated topically with paraffin oil for 3 months. First, the limb with spasticity is washed with soap and water to be completely clean, and after washing, gently Massage the desired limb for 10 minutes until the skin color turns red to some extent. Then pour a few drops of paraffin oil on the limb and start a gentle massage until the oil is completely absorbed by the skin. Massage time is at least 5 minutes and up to 10 minutes. And twice a day. At least an hour after that, the oil should remain on the skin and not be washed.</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:
The results of extracting the modified ashworth scale questionnaire about the subjects can be shared after identifying the subjects.

When:
After taking medication and placebo and completing the modified ashworth scale questionnaire

To whom:
Faculty members of medical universities throughout Iran

Conditions:
With a written request to reuse the files

Where to obtain:
Postal address: Kerman, Kowsar Blvd., Shafa Hospital, Mona Arab E-mail address: Monaarb68@gmail.com Phone number: 09131435195

How to obtain:
The written and official request of the applicant, which has been approved by the Vice Chancellor for Research of the University of the applicant's place of work, will be sent within one week at the latest.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mona Arab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kowsar Blvd, Shafa Hospital</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618751151</zip>
        <telephone>+98 34 3211 5780</telephone>
        <email>monaarb68@gmail .com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rostam Seifaddini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kowsar Blvd-Shafa Hospital</address>
        <city>کرمان</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618751151</zip>
        <telephone>+98 34 3211 5780</telephone>
        <email>r.seifaddini @gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Existence of spasticity disorder</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Sensitivity to kharatin oil</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G04.1</hc_code>
      <hc_code>G81.1</hc_code>
      <hc_code>G35</hc_code>
      <hc_code>G36.0</hc_code>
      <hc_code>P91.60</hc_code>
      <hc_code>M43.02</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Tropical spastic paraplegia</hc_keyword>
      <hc_keyword>Spastic hemiplegia</hc_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
      <hc_keyword>Neuromyelitis optica [Devic]</hc_keyword>
      <hc_keyword>Hypoxic ischemic encephalopathy [HIE], unspecified</hc_keyword>
      <hc_keyword>Spondylolysis, cervical region</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:25 people in the intervention group who have spasticity disorder are treated topically with standard Aral kharatin oil made in Iran for 3 months. First, the limb with spasticity is washed with soap and water to be completely clean, and after washing, gently Massage the desired limb for 10 minutes until the skin color turns red to some extent. Then pour a few drops of kharatin oil on the limb and start a gentle massage until the oil is completely absorbed by the skin. Massage time is at least 5 minutes and up to 10 minutes. And twice a day. At least an hour after that, the oil should remain on the skin and not be washed.</i_keyword>
      <i_keyword>Control group: 25 people in the control group who have spasticity disorder are treated topically with paraffin oil for 3 months. First, the limb with spasticity is washed with soap and water to be completely clean, and after washing, gently Massage the desired limb for 10 minutes until the skin color turns red to some extent. Then pour a few drops of paraffin oil on the limb and start a gentle massage until the oil is completely absorbed by the skin. Massage time is at least 5 minutes and up to 10 minutes. And twice a day. At least an hour after that, the oil should remain on the skin and not be washed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Paralysis  performance score in modified ashworth scale questionnair. Timepoint: At the beginning of the study and 3 months after starting to use kharatin oil and paraffin. Method of measurement: modified ashworth scale questionnair.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life score. Timepoint: At the beginning of the study and 3 months after consuming kharatin oil and paraffin. Method of measurement: World Health Organization Quality of Life 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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-12</approval_date>
        <contact_name>Ethics committe of kerman university of medical sciences</contact_name>
        <contact_address>Kowsar Blvd, Shafa hospital kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
