<?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>IRCT20140221016666N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-19</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of topical curcumin on mild to moderate idiopathic carpal tunnel syndrome</public_title>
      <acronym>CTS: carpal tunnel syndrome</acronym>
      <scientific_title>Efficacy of topical curcumin on mild to moderate Idiopathic carpal tunnel syndrome: a randomized double-blind placebo controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36138</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The case group uses the topical curcumin form two times daily, and the placebo is given to the control group. Sample selection based on Simple Block Randomized.All patients should avoid doing activities that require Extention and Flexion wrists.Medications and placebo make the Nanocin Healthcare company. Both are in the tubes of the same shape and have the same color and density. Both groups use night-time splint, and medications are used once in the morning and once in the evening. The course is for eight weeks and all patients are evaluated at the end of the  eighth week. To evaluate patients from the Visual Analog Scale (VAS) and Boston's questionnaire are used. All results are recorded by the neurologist, which is Blind, Blinding description: Patients and assessors are blind.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Carpal tunnel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Curcumin topical ointment is a turmeric extract and is manufactured by Exir Nanosina.Twice a day in the morning and at the  night, 12 hours interval, in the anterior of wrist is rubbed. duration of treatment is 8-week.The ointment should not be washed up to 2 hours after using the ointment. Intervention 2: Control group: The placebo is an ointment that has a shape, color and concentration similar to curcumin ointment. The tubes are in the same shape.Produced by Exir Nanosina company.The frequency of use, dose and duration of use is the similar to intervention group.</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:
Only the part of the data about the main of outcome  will be shared

When:
the access period is 6 months after publishing  the results

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
Only for scientific use

Where to obtain:
Narges Karimi Email: Drkarimi_236@yahoo.com

How to obtain:
Noting the reason for requesting and identifying the type of applicant institution
Email: Drkarimi_236@yahoo.com
After review and, if possible, the data will be sent

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.47, Mirjani street, Baghsang street, Panzdah khordad street</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818734619</zip>
        <telephone>+98 11 3311 6275</telephone>
        <email>Drkarimi_236@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baran department, Mirjani Street, Panzdah khordad street, Baghsang street,</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818734619</zip>
        <telephone>+98 11 3311 6275</telephone>
        <email>Drkarimi_236@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female patients aged 18-65 years old completed the informed consent form
Sign and symptoms of carpal tunnel syndrome: at least two symptoms or one symptom and one sign including: pain, paresthesia, hypoesthesia, numbness, positive phalen or tinel test
Electrodiagnostic evidence suggestive of mild to moderate idiopathic carpal tunnel syndrome</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Positive history of the curcumin hypersensitivity
Failure to complete the information collection form
Cervical radiculopathy or brachial plexopathy, TOS,Protator teres syndrome, ulnar neuropathy
Clinical Signs or Electrodiagnostic evidence of Polyneuropathy
Rheumatologic disorders such as: rheumatoid arthritis, systemic sclerosis, Lupus, Amyloidosis and so on
Endocrine disorders: Diabetes, hypothyroid
Conditions that mimic carpal tunnel syndrome, such as multiple sclerosis
Pregnancy and lactation
Serious cardiovascular disease like heart failure and kidney disease
Intravenous injection or physiotherapy for the treatment of carpal tunnel syndrome over the past 6 months
A positive history of a severe trauma or fracture of the wrist
The inevitable use of corticosteroids or analgesic drugs
Patients with severe carpal tunnel syndrome based on clinical or electrodiagnostic evidence</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G56.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Carpal tunnel syndrome</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: Curcumin topical ointment is a turmeric extract and is manufactured by Exir Nanosina.Twice a day in the morning and at the  night, 12 hours interval, in the anterior of wrist is rubbed. duration of treatment is 8-week.The ointment should not be washed up to 2 hours after using the ointment.</i_keyword>
      <i_keyword>Control group: The placebo is an ointment that has a shape, color and concentration similar to curcumin ointment. The tubes are in the same shape.Produced by Exir Nanosina company.The frequency of use, dose and duration of use is the similar to intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Boston questionnaire score and severity of pain according to VAS. Timepoint: Before intervention and Eighth week after treatment. Method of measurement: Boston questionnaire and  VAS.</prim_outcome>
      <prim_outcome>EMG-NCV parameters changes. Timepoint: Before intervention and Eighth week after treatment. Method of measurement: Electrodiagnostic.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-08</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sceinces</contact_name>
        <contact_address>Joibar Three ways, Valiasr blvd, Sari city Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
