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/NCT06025097</url>
    </required_header>
    <id_info>
      <org_study_id>001</org_study_id>
      <nct_id>NCT06025097</nct_id>
    </id_info>
    <brief_title>Intra-Tympanic Steroid With PRP Combination in Sensorineural Hearing Loss and Tinnitus.</brief_title>
    <official_title>Therapeutic Effect of Intra-Tympanic Methyl Prednisone-platelet Rich Plasma Combination in Sensorineural Hearing Loss and Tinnitus of Cochlear Origin.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CMH RWP Combined Military Hospital RWP: Rawalpindi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CMH RWP Combined Military Hospital RWP: Rawalpindi</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Steroids are used widely for the treatment of Sensorineural hearing loss worldwide. The&#xD;
        difficulty lies with efficient delivery of the drug into the cochlea, which is already a&#xD;
        sealed chamber with limited blood supply that too with an end Artery. We intend to&#xD;
        extrapolate its effects by combining it with Platelet rich plasma. intra-tympanic delivery is&#xD;
        achieved with injection via tympanic membrane and its absorption via round window is hastened&#xD;
        by posture maintenance for about half an hour. PRP is an autologous biologic fluid which has&#xD;
        excellent safety profile and is already in use by various specialties.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Definitions:&#xD;
  &#xD;
        Sensorineural Hearing Loss: Hearing loss occurring due to pathologies of cochlea.&#xD;
  &#xD;
        Platelet-rich plasma : Platelet-rich plasma is an autologous biological product separated&#xD;
        from blood after removal of Red blood cells. It is the plasma portion of blood which is&#xD;
        simply rich of platelets.&#xD;
  &#xD;
        Preparations:&#xD;
  &#xD;
        Intratympanic methyl prednisone + Autologous PRP: 2ml Solution (1ml of methyl prednisone&#xD;
        40mg/ml + 1ml of PRP)&#xD;
  &#xD;
        Materials and Methods:&#xD;
  &#xD;
        Inclusion Criteria:&#xD;
  &#xD;
        mentioned in pertinent section&#xD;
  &#xD;
        Exclusion Criteria:&#xD;
  &#xD;
        mentioned in pertinent section&#xD;
  &#xD;
        Methodology:&#xD;
  &#xD;
        This will be an Interventional study, prior permission from Hospitals Ethical Review Board&#xD;
        will be taken. Informed consent will be obtained from the patients with regards to&#xD;
        participation the study. All the patients in which the presentation to Ear Nose Throat (ENT)&#xD;
        clinic is SNHL or Subjective tinnitus and also satisfying the inclusion criteria will be&#xD;
        selected. SNHL will be graded according to the audiogram and values will be recorded to the&#xD;
        nearest +5db with round off. The Tinnitus will be graded on visual analogue scale graded from&#xD;
        1 to 10 (1= No tinnitus while 10 being the worst). After recording the pre-treatment data&#xD;
        these patients will be scheduled for intervention. Patients will receive the solution&#xD;
        consisting of 1ml methyl prednisone (40mg/ml) and 1ml of PRP via intra-tympanic route. The&#xD;
        solution will be injected into the tympanic cavity via the tympanic membrane injection&#xD;
        (intra-tympanic route). Patients will receive repeated doses of same intra-tympanic&#xD;
        injections on every third day for a total of 3 consecutive doses (in 9 days). Hearing&#xD;
        assessment via Audiometry will be done post-treatment after 2 weeks of finishing the&#xD;
        treatment (23rd day after starting the therapy).&#xD;
  &#xD;
        Procedure: On receiving a patient at ENT department with a diagnosis of SNHL/ tinnitus,&#xD;
        patient will be scheduled for intra-tympanic injection session. All of the intra-tympanic&#xD;
        injections will be performed by the same ENT Doctor. Patient will be positioned in sitting&#xD;
        posture, head tilted sideways and rotated slightly to instill the pyodine solution into the&#xD;
        ear for 5 minutes. Then after cleaning with a sterile suction tip, xylocaine 10% solution&#xD;
        will be sprayed into the ear canal and a wick soaked in xylocaine left there for 5 more&#xD;
        minutes. The wick will then be removed and ear will be examined to exclude any physical&#xD;
        disease or deformity in the external ear. Head will be brought to the examining position and&#xD;
        a sterile 3cc syringe will be loaded with 1 ml of 40mg/ml methyl prednisone and 1 ml of PRP.&#xD;
        3cc syringe needle is replaced with 25 Guage Lumber Puncture needle. Under guidance of a&#xD;
        Microscope or 0-degree rigid Endoscope, one point Pin-hole will be made by just piercing the&#xD;
        Tympanic membrane antero-inferiorly and the prepared solution will be instilled. While&#xD;
        instilling the solution a meniscus would be seen rising from inferior to superior aspect of&#xD;
        the tympanic membrane. The patient will be made to lie in supine position and then will be&#xD;
        made to stay in same position for about 15-30 mins (so as to hasten the absorption through&#xD;
        round window and to prevent escape of solution via Eustachian tube). This supine position&#xD;
        would also facilitate establishment of a reservoir in the mastoid antrum to slowly discharge&#xD;
        over time and further the absorption through round window. A cotton wick will be left in the&#xD;
        ear canal to be removed after an hour. The procedure will be repeated at every 3rd day till a&#xD;
        total of three procedures. Patient will be further called for follow up Audiometry, at 2&#xD;
        weeks after finishing the treatment. Any improvement from the pre-treatment audiometry will&#xD;
        be noted. Improvement will be labelled as Mild; of 10 decibels, partial; 11-25 decibels and&#xD;
        Good; above 25 decibels. The improvements in tinnitus will be ascertained subjectively with a&#xD;
        visual analogue scale graded from 1 to 10. Data will be recorded and analyzed and results&#xD;
        will be published in due course of time.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 21, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single group study, to show the therapeutic effects of Combination solution on diseases in fixed time.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Care giver and patient both are known to the treatment being offered under investigation.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Improvement in Hearing</measure>
      <time_frame>2 weeks post treatment completion.</time_frame>
      <description>Improvement in hearing as per Audiogram, measured in decibels.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Improvement in Tinnitus</measure>
      <time_frame>2 weeks post treatment completion.</time_frame>
      <description>Improvement in Tinnitus as per Visual analogue scale from 1 to 10 with 1 being the lowest improvement and 10 being the best.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Sensorineural Hearing Loss</condition>
    <condition>Tinnitus</condition>
    <arm_group>
      <arm_group_label>Single Treated Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single arm study, Patients with SNHL and Tinnitus all were given same Composite solution consisting of (Methyl prednisone and Platelet rich plasma) via intr-atympanic route..</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Combination Solution</intervention_name>
      <description>Methyl Prednisone (Trade name: SOLU-MEDROL) + Platelet rich Plasma (Autologous Biological product) via intra-tympanic rout about 1-1.5 ml.</description>
      <arm_group_label>Single Treated Arm</arm_group_label>
      <other_name>PRP + Solumedrol</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age: 10-70 yrs&#xD;
  &#xD;
            -  Capacity to have a Pure tone Audiometry test&#xD;
  &#xD;
            -  Disease&#xD;
  &#xD;
                 1. SNHL;&#xD;
  &#xD;
                      -  Unilateral or bilateral sensorineural hearing loss&#xD;
  &#xD;
                      -  Without any identifiable cause&#xD;
  &#xD;
                 2. Tinnitus;&#xD;
  &#xD;
                      -  Subjective sensation of noise without any obvious source of sound&#xD;
  &#xD;
                      -  Without any identifiable cause&#xD;
  &#xD;
            -  Hearing levels of 55dB or above&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age: less than 10 or more than 70 yrs&#xD;
  &#xD;
            -  Conductive hearing loss/ Mixed Hearing loss&#xD;
  &#xD;
            -  Tumor, Neurologic cause of hearing loss/ tinnitus&#xD;
  &#xD;
            -  Past ear Surgery&#xD;
  &#xD;
            -  Any External, middle or inner Ear Disease other than SSNHL&#xD;
  &#xD;
            -  Traumatic Hearing Loss or Hearing Loss due to an obvious cause.&#xD;
  &#xD;
            -  Patients' refusal to follow-up&#xD;
  &#xD;
            -  Any contraindication to Steroids administration.&#xD;
  &#xD;
            -  Any Blood Disorder&#xD;
  &#xD;
            -  Non-consenting patients&#xD;
  &#xD;
            -  Comorbid:&#xD;
  &#xD;
                 -  Diabetes&#xD;
  &#xD;
                 -  Hypertension&#xD;
  &#xD;
                 -  Cardio vascular diseases&#xD;
  &#xD;
                 -  Obesity&#xD;
  &#xD;
                 -  Etc.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Farhan Akbar, FCPS</last_name>
      <role>Study Director</role>
      <affiliation>CMH Rawalpindi</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Muhammad Noman Karim, MBBS</last_name>
      <phone>03090062305</phone>
      <email>f9noman@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Muhammad Noman, FCPS</last_name>
      <phone>03313358884</phone>
      <email>f7nomi@gmail.com</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>CMH RWP Combined Military Hospital RWP: Rawalpindi</investigator_affiliation>
      <investigator_full_name>Muhammad Noman Karim</investigator_full_name>
      <investigator_title>Principal Investigator, Otolaryngology Dept, CMH Rawalpindi</investigator_title>
    </responsible_party>
    <keyword>Steroids</keyword>
    <keyword>Platelet rich plasma</keyword>
    <keyword>intratympanic steroids</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hearing Loss</mesh_term>
      <mesh_term>Deafness</mesh_term>
      <mesh_term>Tinnitus</mesh_term>
      <mesh_term>Hearing Loss, Sensorineural</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>If there is a need to analyze the data for a particular clinical question, than only the data would be shared with other researchers.</ipd_description>
    </patient_data>
    <!-- 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/NCT06025097
  org study id: 001
  nct id: NCT06025097
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  Steroids are used widely for the treatment of Sensorineural hearing loss worldwide. The
        difficulty lies with efficient delivery of the drug into the cochlea, which is already a
        sealed chamber with limited blood supply that too with an end Artery. We intend to
        extrapolate its effects by combining it with Platelet rich plasma. intra-tympanic delivery is
        achieved with injection via tympanic membrane and its absorption via round window is hastened
        by posture maintenance for about half an hour. PRP is an autologous biologic fluid which has
        excellent safety profile and is already in use by various specialties.
  Definitions:
  
        Sensorineural Hearing Loss: Hearing loss occurring due to pathologies of cochlea.
  
        Platelet-rich plasma : Platelet-rich plasma is an autologous biological product separated
        from blood after removal of Red blood cells. It is the plasma portion of blood which is
        simply rich of platelets.
  
        Preparations:
  
        Intratympanic methyl prednisone + Autologous PRP: 2ml Solution (1ml of methyl prednisone
        40mg/ml + 1ml of PRP)
  
        Materials and Methods:
  
        Inclusion Criteria:
  
        mentioned in pertinent section
  
        Exclusion Criteria:
  
        mentioned in pertinent section
  
        Methodology:
  
        This will be an Interventional study, prior permission from Hospitals Ethical Review Board
        will be taken. Informed consent will be obtained from the patients with regards to
        participation the study. All the patients in which the presentation to Ear Nose Throat (ENT)
        clinic is SNHL or Subjective tinnitus and also satisfying the inclusion criteria will be
        selected. SNHL will be graded according to the audiogram and values will be recorded to the
        nearest +5db with round off. The Tinnitus will be graded on visual analogue scale graded from
        1 to 10 (1= No tinnitus while 10 being the worst). After recording the pre-treatment data
        these patients will be scheduled for intervention. Patients will receive the solution
        consisting of 1ml methyl prednisone (40mg/ml) and 1ml of PRP via intra-tympanic route. The
        solution will be injected into the tympanic cavity via the tympanic membrane injection
        (intra-tympanic route). Patients will receive repeated doses of same intra-tympanic
        injections on every third day for a total of 3 consecutive doses (in 9 days). Hearing
        assessment via Audiometry will be done post-treatment after 2 weeks of finishing the
        treatment (23rd day after starting the therapy).
  
        Procedure: On receiving a patient at ENT department with a diagnosis of SNHL/ tinnitus,
        patient will be scheduled for intra-tympanic injection session. All of the intra-tympanic
        injections will be performed by the same ENT Doctor. Patient will be positioned in sitting
        posture, head tilted sideways and rotated slightly to instill the pyodine solution into the
        ear for 5 minutes. Then after cleaning with a sterile suction tip, xylocaine 10% solution
        will be sprayed into the ear canal and a wick soaked in xylocaine left there for 5 more
        minutes. The wick will then be removed and ear will be examined to exclude any physical
        disease or deformity in the external ear. Head will be brought to the examining position and
        a sterile 3cc syringe will be loaded with 1 ml of 40mg/ml methyl prednisone and 1 ml of PRP.
        3cc syringe needle is replaced with 25 Guage Lumber Puncture needle. Under guidance of a
        Microscope or 0-degree rigid Endoscope, one point Pin-hole will be made by just piercing the
        Tympanic membrane antero-inferiorly and the prepared solution will be instilled. While
        instilling the solution a meniscus would be seen rising from inferior to superior aspect of
        the tympanic membrane. The patient will be made to lie in supine position and then will be
        made to stay in same position for about 15-30 mins (so as to hasten the absorption through
        round window and to prevent escape of solution via Eustachian tube). This supine position
        would also facilitate establishment of a reservoir in the mastoid antrum to slowly discharge
        over time and further the absorption through round window. A cotton wick will be left in the
        ear canal to be removed after an hour. The procedure will be repeated at every 3rd day till a
        total of three procedures. Patient will be further called for follow up Audiometry, at 2
        weeks after finishing the treatment. Any improvement from the pre-treatment audiometry will
        be noted. Improvement will be labelled as Mild; of 10 decibels, partial; 11-25 decibels and
        Good; above 25 decibels. The improvements in tinnitus will be ascertained subjectively with a
        visual analogue scale graded from 1 to 10. Data will be recorded and analyzed and results
        will be published in due course of time.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single group study, to show the therapeutic effects of Combination solution on diseases in fixed time.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: Care giver and patient both are known to the treatment being offered under investigation.
  measure: Improvement in Hearing
  time frame: 2 weeks post treatment completion.
  description: Improvement in hearing as per Audiogram, measured in decibels.
  measure: Improvement in Tinnitus
  time frame: 2 weeks post treatment completion.
  description: Improvement in Tinnitus as per Visual analogue scale from 1 to 10 with 1 being the lowest improvement and 10 being the best.
  arm group label: Single Treated Arm
  arm group type: Experimental
  description: Single arm study, Patients with SNHL and Tinnitus all were given same Composite solution consisting of (Methyl prednisone and Platelet rich plasma) via intr-atympanic route..
  intervention type: Drug
  intervention name: Combination Solution
  description: Methyl Prednisone (Trade name: SOLU-MEDROL) + Platelet rich Plasma (Autologous Biological product) via intra-tympanic rout about 1-1.5 ml.
  arm group label: Single Treated Arm
  other name: PRP + Solumedrol
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Farhan Akbar, FCPS
  role: Study Director
  affiliation: CMH Rawalpindi
  last name: Muhammad Noman Karim, MBBS
  phone: 03090062305
  email: f9noman@gmail.com
  last name: Muhammad Noman, FCPS
  phone: 03313358884
  email: f7nomi@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: CMH RWP Combined Military Hospital RWP: Rawalpindi
  investigator full name: Muhammad Noman Karim
  investigator title: Principal Investigator, Otolaryngology Dept, CMH Rawalpindi
  mesh term: Hearing Loss
  mesh term: Deafness
  mesh term: Tinnitus
  mesh term: Hearing Loss, Sensorineural
  mesh term: Methylprednisolone Hemisuccinate
  sharing ipd: No
  ipd description: If there is a need to analyze the data for a particular clinical question, than only the data would be shared with other researchers.