<?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>IRCT20220615055179N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-03</date_registration>
      <primary_sponsor>Muhammad Nawaz Sharif University of Agriculture</primary_sponsor>
      <public_title>Evaluation of Brassica oleracea and Zingiber officinale Gel in Frozen Shoulder</public_title>
      <acronym></acronym>
      <scientific_title>Formulation and Evaluation of Brassica oleracea and Zingiber officinale Gel in Frozen Shoulder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>375</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81077</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The lottery method will be used for the randomization of participants into five groups in which the names of participants will be written on slips and put their name slips in the box, then will be selected independently by the lottery method, Blinding description: It is a single-blinded study. The data analyzer will be kept blind to avoid any biasness and for correct authentication and validation of the results.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Adhesive capsulitis of shoulder.</hc_freetext>
      <i_freetext>Intervention 1: Group 1 will be treated with a test herbal gel 5% w/w with phonophoresis with therapeutic ultrasound (frequency of 0.8MH, and an intensity of about 1.5 W/cm2, and with the continuous mode) along with shoulder mobilization and muscle energy technique (MET) exercises for 3-4 weeks. Intervention 2: Group 2 will be treated with the standard drug piroxicam 0.5% w/w with phonophoresis with therapeutic ultrasound (frequency of 0.8MH, and an intensity of about 1.5 W/cm2, and with the continuous mode) along with shoulder mobilization and muscle energy technique (MET) exercises for 3-4 weeks. Intervention 3: Group 3 will be treated with therapeutic ultrasound using aqueous gel as coupling media as a placebo or control group placebo gel along with shoulder mobilization and muscle energy technique (MET) exercises for 3-4 weeks.</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 It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Qurat-Ul- Ain</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HBL street, near Sabzazar metro station, Bosan road.</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 303 9427506</telephone>
        <email>qain0635@gmail.com</email>
        <affiliation>Muhammad Institute of Medical and Allied Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Imran Ahmad Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Agriculture Complex, Old Shuja Abad Road</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 333 6120602</telephone>
        <email>imran.ahmad@mnsuam.edu.pk</email>
        <affiliation>Muhammad Nawaz Sharif University of Agriculture</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants diagnosed with frozen shoulder and stiff frozen shoulder
Limited shoulder joint range of motion
Participants who have experienced pain (NPRS &gt; 4) during movement
Age (30- 60 y)
Symptom duration &gt; 3 months</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of fracture around shoulder
Inflammatory disorder around shoulder
Any neurological condition
Cardiac conditions
Acute or chronic conditions affecting joint mobility
Surgical release of capsules
History of steroidal injection in the affected area
Patients with joint infection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adhesive capsulitis of shoulder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group 1 will be treated with a test herbal gel 5% w/w with phonophoresis with therapeutic ultrasound (frequency of 0.8MH, and an intensity of about 1.5 W/cm2, and with the continuous mode) along with shoulder mobilization and muscle energy technique (MET) exercises for 3-4 weeks.</i_keyword>
      <i_keyword>Group 2 will be treated with the standard drug piroxicam 0.5% w/w with phonophoresis with therapeutic ultrasound (frequency of 0.8MH, and an intensity of about 1.5 W/cm2, and with the continuous mode) along with shoulder mobilization and muscle energy technique (MET) exercises for 3-4 weeks.</i_keyword>
      <i_keyword>Group 3 will be treated with therapeutic ultrasound using aqueous gel as coupling media as a placebo or control group placebo gel along with shoulder mobilization and muscle energy technique (MET) exercises for 3-4 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Shoulder range of motion. Timepoint: Pre (before starting the intervention) and Post evaluation (after every 3rd session of treatment, evaluation will be done). Method of measurement: Goniometry.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Pre (before starting the intervention) and Post evaluation (daily after each treatment session, evaluation will be done). Method of measurement: Visual Analog Scale (VAS) and Numerical Pain Rating Scale (NPRS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Inflammation. Timepoint: Pre (before starting the intervention) and Post evaluation (after 3-4 weeks when treatment sessions/ intervention will be completed depending on different individuals and conditions or grades of other individuals). Method of measurement: C-reactive protein (CRP) and Erythrocyte Sedimentation Rate (ESR).</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>Muhammad Nawaz Sharif University of Agriculture</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-12</approval_date>
        <contact_name>Ethic's Committee of Muhammad Institute of Medical and Allied Sciences, Multan.</contact_name>
        <contact_address>HBL street, near Sabzazar metro station, Bosan road. Multan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
