xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06034106</url>
    </required_header>
    <id_info>
      <org_study_id>getat51</org_study_id>
      <nct_id>NCT06034106</nct_id>
    </id_info>
    <brief_title>The Effect of Pomegranate (Punica Granatum L.) Peel Compress Application on Pain and Physical Function Status</brief_title>
    <acronym>Pomegranate</acronym>
    <official_title>The Effect of Pomegranate (Punica Granatum L.) Peel Compress Application on Pain and Physical Function Status in Patients With Knee Osteoarthritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>TC Erciyes University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>TC Erciyes University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Osteoarthritis is the most common type of arthritis among rheumatologic diseases.&#xD;
        Complementary therapies are one of the effective methods for pain control. This study was&#xD;
        planned as a randomized controlled experimental study. For this purpose, patients diagnosed&#xD;
        with knee osteoarthritis who applied to the Orthopedics Outpatient Clinic will be included.&#xD;
        It was calculated that the study would include at least 67 patients. The study will be&#xD;
        collected using patient information form, descriptive characteristics form, Visual Analog&#xD;
        Scale (VAS) and WOMAC osteoarthritis application scale. It was planned as a randomized&#xD;
        controlled experimental study to evaluate the effect of pomegranate peel (P. granatum)&#xD;
        compress application on pain and function status. The study was divided into 3 groups as&#xD;
        Pomegranate (Punica granatum) peel compress, hot compress and control group. Pomegranate&#xD;
        (Punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder&#xD;
        into porridge check.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This randomized controlled experimental study was conducted to evaluate the effect of&#xD;
        pomegranate (Punica granatum) peel compress application on pain, stiffness and physical&#xD;
        function in individuals with knee osteoarthritis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">April 14, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analog Scale</measure>
      <time_frame>The scale was filled in the baseline</time_frame>
      <description>A VAS consisting of a 10-centimeter horizontal line, anchored evenly by numbers from 0 to 10, was used to assess the patient's pain and willingness to repeat the procedure. The number 0 was identical to having no pain while the number 10 corresponded to maximal pain that can be experienced by the patient</description>
    </primary_outcome>
    <primary_outcome>
      <measure>WOMAC Osteoarthritis Index</measure>
      <time_frame>The scale was filled in the baseline</time_frame>
      <description>The WOMAC index is composed of 24 items and 3 subdimensions (pain, stiffness, and physical function). The participants are asked to rate pain (5 questions), stiffness (2 questions), and difficulties encountered in physical functioning (17 questions) during the day (24 hours). The index is a 5-point Likert-type scale, where 0 is none, 1 mild, 2 moderate, 3 severe, and 4 very severe. Pain scores range from 0e20 points, stiffness scores from 0e8 points, and difficulties in physical function scores from 0e68 points. Higher scores indicate increased pain and stiffness, impairment in physical functioning, and higher levels of physical limitation.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">67</enrollment>
    <condition>Pomegranate (P. Granatum) Peel Compress</condition>
    <arm_group>
      <arm_group_label>Pomegranate (P. granatum) peel compress group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>36 g of pomegranate peel powder was given to the patient in a closed container. A teaspoon (approximately 2-3 g) of powder was mixed with water from the storage container and applied to the patient's knee by making a paste, and then the knee was wrapped with a bandage. It was kept for 20 minutes by placing a hot thermophore (approximately 40-45 C) on it. This application was carried out 3 days a week.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Hot compress</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>In the hot compress group, the knee was wrapped with a bandage and the hot thermophor (approximately 40-45 °C) was placed on the knee. The hot thermoform was applied to the patient 3 days a week by keeping it for 20 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients in the control group did not receive any additional intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Pomegranate (Punica granatum) peel compress</intervention_name>
      <description>Pomegranate (Punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder into porridge check.</description>
      <arm_group_label>Hot compress</arm_group_label>
      <arm_group_label>Pomegranate (P. granatum) peel compress group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Hot compress</intervention_name>
      <description>Hot compress was applied 3 days a week for 3 weeks.</description>
      <arm_group_label>Hot compress</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Visual analog scale score of 3 and above,&#xD;
  &#xD;
            -  those aged 45 and over,&#xD;
  &#xD;
            -  Diagnosed with knee OA by a physician according to the criteria of the American -&#xD;
               Rheumatology Association (ARD),&#xD;
  &#xD;
            -  pain lasting at least 1 month or longer,&#xD;
  &#xD;
            -  not included in any physical therapy program during the research period, a&#xD;
  &#xD;
            -  capable of answering research questions,&#xD;
  &#xD;
            -  agreeing to participate in the research by giving verbal and written consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  with a defined psychiatric illness,&#xD;
  &#xD;
            -  having vision and hearing problems,&#xD;
  &#xD;
            -  diagnosed with complex disease such as malignant,&#xD;
  &#xD;
            -  having a wound in the application area,&#xD;
  &#xD;
            -  with a diagnosed vascular disease,&#xD;
  &#xD;
            -  the patient's other inflammatory disease such as rheumatoid arthritis, gout,&#xD;
               fibromyalgia&#xD;
  &#xD;
            -  who have had serious trauma or surgery in the last 6 months,&#xD;
  &#xD;
            -  who have received DMARDS or intra-articular steroid injection therapy in the last 3&#xD;
               months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>DİLEK EFE ARSLAN</last_name>
      <role>Study Director</role>
      <affiliation>ERCİYES UNİVERSİTY</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Dilek Efe Arslan</name>
        <address>
          <city>Kayseri</city>
          <state>Melikgazi</state>
          <zip>38280</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>TC Erciyes University</investigator_affiliation>
      <investigator_full_name>Dilek Efe Arslan</investigator_full_name>
      <investigator_title>ErciyesU</investigator_title>
    </responsible_party>
    <keyword>pain</keyword>
    <keyword>osteoarthritis</keyword>
    <keyword>rheumatologic diseases</keyword>
    <keyword>physical function</keyword>
    <keyword>stiffness</keyword>
    <keyword>nursing</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06034106
  org study id: getat51
  nct id: NCT06034106
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Osteoarthritis is the most common type of arthritis among rheumatologic diseases.
        Complementary therapies are one of the effective methods for pain control. This study was
        planned as a randomized controlled experimental study. For this purpose, patients diagnosed
        with knee osteoarthritis who applied to the Orthopedics Outpatient Clinic will be included.
        It was calculated that the study would include at least 67 patients. The study will be
        collected using patient information form, descriptive characteristics form, Visual Analog
        Scale (VAS) and WOMAC osteoarthritis application scale. It was planned as a randomized
        controlled experimental study to evaluate the effect of pomegranate peel (P. granatum)
        compress application on pain and function status. The study was divided into 3 groups as
        Pomegranate (Punica granatum) peel compress, hot compress and control group. Pomegranate
        (Punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder
        into porridge check.
  This randomized controlled experimental study was conducted to evaluate the effect of
        pomegranate (Punica granatum) peel compress application on pain, stiffness and physical
        function in individuals with knee osteoarthritis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: Visual Analog Scale
  time frame: The scale was filled in the baseline
  description: A VAS consisting of a 10-centimeter horizontal line, anchored evenly by numbers from 0 to 10, was used to assess the patient's pain and willingness to repeat the procedure. The number 0 was identical to having no pain while the number 10 corresponded to maximal pain that can be experienced by the patient
  measure: WOMAC Osteoarthritis Index
  time frame: The scale was filled in the baseline
  description: The WOMAC index is composed of 24 items and 3 subdimensions (pain, stiffness, and physical function). The participants are asked to rate pain (5 questions), stiffness (2 questions), and difficulties encountered in physical functioning (17 questions) during the day (24 hours). The index is a 5-point Likert-type scale, where 0 is none, 1 mild, 2 moderate, 3 severe, and 4 very severe. Pain scores range from 0e20 points, stiffness scores from 0e8 points, and difficulties in physical function scores from 0e68 points. Higher scores indicate increased pain and stiffness, impairment in physical functioning, and higher levels of physical limitation.
  arm group label: Pomegranate (P. granatum) peel compress group
  arm group type: Experimental
  description: 36 g of pomegranate peel powder was given to the patient in a closed container. A teaspoon (approximately 2-3 g) of powder was mixed with water from the storage container and applied to the patient's knee by making a paste, and then the knee was wrapped with a bandage. It was kept for 20 minutes by placing a hot thermophore (approximately 40-45 C) on it. This application was carried out 3 days a week.
  arm group label: Hot compress
  arm group type: Placebo Comparator
  description: In the hot compress group, the knee was wrapped with a bandage and the hot thermophor (approximately 40-45 °C) was placed on the knee. The hot thermoform was applied to the patient 3 days a week by keeping it for 20 minutes.
  arm group label: Control Group
  arm group type: No Intervention
  description: Patients in the control group did not receive any additional intervention.
  intervention type: Behavioral
  intervention name: Pomegranate (Punica granatum) peel compress
  description: Pomegranate (Punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder into porridge check.
  arm group label: Hot compress
  arm group label: Pomegranate (P. granatum) peel compress group
  intervention type: Behavioral
  intervention name: Hot compress
  description: Hot compress was applied 3 days a week for 3 weeks.
  arm group label: Hot compress
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: DİLEK EFE ARSLAN
  role: Study Director
  affiliation: ERCİYES UNİVERSİTY
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: TC Erciyes University
  investigator full name: Dilek Efe Arslan
  investigator title: ErciyesU