<?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>IRCT20230202057310N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-22</date_registration>
      <primary_sponsor>Muhammad Institute of Medical and Allied Sciences, Multan</primary_sponsor>
      <public_title>Curcumin Gel Along With Ultrasound and Eccentric Exercises On Patellar Tendinopathy Management</public_title>
      <acronym></acronym>
      <scientific_title>Formulation And Evaluation of Curcumin Gel Along With Ultrasound and Eccentric Exercises On Patellar Tendinopathy Management</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80759</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization process will be conducted using computer-generated random numbers to assign participants to treatment groups in a predefined allocation sequence. A stratified or block randomization approach will be used to ensure balance between groups for key variables (e.g., age, gender, baseline disease severity). Medications will be prepared and packaged in identical numbered white boxes according to the allocation sequence. Each box will have a unique medication number corresponding to the assigned treatment, ensuring blinding. The allocation sequence and treatment codes will be securely stored and accessible only to the principal investigator, who is not involved in participant interactions or outcome assessments, Blinding description: The statistical analyst and outcome assessor will be blinded to treatment allocation by using securely stored randomization codes, accessible only to an independent party. Data will be analyzed using anonymous identifiers, and group allocation will be revealed only after data collection and analysis are complete. This ensures minimization of bias.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Patellar Tendinopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A: Curcumin-aloe vera gel + ultrasound + eccentric exercises; Ultrasound Application:    - Administer therapeutic ultrasound using a frequency of 3 MHz in pulsed mode (intensity of 1–1.5 W/cm²) for 5–10 minutes on the patellar tendon area.  Apply curcumin-aloe vera gel before ultrasound therapy to enhance penetration.  Treatment frequency: 3 times per week.  Focus on slow eccentric loading exercises for the quadriceps, such as decline squats.     - Exercise progression: Gradually increase weight/resistance over 8 weeks.     - Sessions: 3–4 times per week, supervised by a physiotherapist. Intervention 2: Control group: Group B: Placebo-aloe vera gel + ultrasound + eccentric exercises (Ultrasound Application:    - Administer therapeutic ultrasound using a frequency of 3 MHz in pulsed mode (intensity of 1–1.5 W/cm²) for 5–10 minutes on the patellar tendon area.  Apply placebo-aloe vera gel before ultrasound therapy to enhance penetration.  Treatment frequency: 3 times per week.  Focus on slow eccentric loading exercises for the quadriceps, such as decline squats.     - Exercise progression: Gradually increase weight/resistance over 8 weeks.     - Sessions: 3–4 times per week, supervised by a physiotherapist.</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 N/A</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maliha Khalid Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Multan</address>
        <city>MULTAN</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 312 6827130</telephone>
        <email>malihatareen1997@gmail.com</email>
        <affiliation>Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Imran Ahmad Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Old shuja Abad road Multan</address>
        <city>-----Select-----</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 between 18 to 60 years of age
Clinical diagnosis of patellar tendinopathy, confirmed by a qualified healthcare professional Individuals
Experiencing chronic patellar tendinopathy symptoms for at least 3 months
Moderate severity of symptoms
No active inflammatory conditions (e.g., rheumatoid arthritis) or uncontrolled systemic diseases that might affect tendon healing or the safety of treatments.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Individuals with acute (less than 3 months) patellar tendinopathy or other acute knee injuries.
Participants with other significant knee conditions (e.g., patellofemoral pain syndrome, osteoarthritis, ligament injuries, or meniscal tears) that may confound the outcomes or interact with the treatments being tested
Those who have undergone surgical interventions involving the patellar tendon or knee in the past 6 months.
Individuals with uncontrolled systemic diseases, including rheumatoid arthritis, diabetes mellitus, or severe cardiovascular or neurological conditions that could affect tendon healing or physical activity.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M76.50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Patellar tendinitis, unspecified knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group A: Curcumin-aloe vera gel + ultrasound + eccentric exercises; Ultrasound Application:    - Administer therapeutic ultrasound using a frequency of 3 MHz in pulsed mode (intensity of 1–1.5 W/cm²) for 5–10 minutes on the patellar tendon area.  Apply curcumin-aloe vera gel before ultrasound therapy to enhance penetration.  Treatment frequency: 3 times per week.  Focus on slow eccentric loading exercises for the quadriceps, such as decline squats.     - Exercise progression: Gradually increase weight/resistance over 8 weeks.     - Sessions: 3–4 times per week, supervised by a physiotherapist.</i_keyword>
      <i_keyword>Control group: Group B: Placebo-aloe vera gel + ultrasound + eccentric exercises (Ultrasound Application:    - Administer therapeutic ultrasound using a frequency of 3 MHz in pulsed mode (intensity of 1–1.5 W/cm²) for 5–10 minutes on the patellar tendon area.  Apply placebo-aloe vera gel before ultrasound therapy to enhance penetration.  Treatment frequency: 3 times per week.  Focus on slow eccentric loading exercises for the quadriceps, such as decline squats.     - Exercise progression: Gradually increase weight/resistance over 8 weeks.     - Sessions: 3–4 times per week, supervised by a physiotherapist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before interventions and 8 weeks after intervention. Method of measurement: Numerical Pain rating scale and Western Ontario and McMaster Universities Osteoarthritis Index.</prim_outcome>
      <prim_outcome>Knee range of motion (ROM). Timepoint: Before interventions and 8 weeks after intervention. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Tendon thickness. Timepoint: Before interventions and 8 weeks after intervention. Method of measurement: ultrasound.</prim_outcome>
      <prim_outcome>Tendon function. Timepoint: Before interventions and 8 weeks after intervention. Method of measurement: Victorian Institute of Sport Assessment-Achilles (VISA-A).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Muscle Strength. Timepoint: Before interventions and 8 weeks after intervention. Method of measurement: Hand dynamometer.</sec_outcome>
      <sec_outcome>Erythrocyte sedimentation rate (ESR). Timepoint: Before interventions and 8 weeks after intervention. Method of measurement: Lab test.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before interventions and 8 weeks after intervention. Method of measurement: SF-36 scale.</sec_outcome>
      <sec_outcome>C-Reactive proteins. Timepoint: Before interventions and 8 weeks after intervention. Method of measurement: Lab test.</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 Institute of Medical and Allied Sciences, Multan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-11-29</approval_date>
        <contact_name>The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences</contact_name>
        <contact_address>Bosan Road Multan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
