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Intra-Tympanic Steroid With PRP Combination in Sensorineural Hearing Loss and Tinnitus.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT06025097
Recruitment Status : Completed
First Posted : September 6, 2023
Last Update Posted : February 22, 2024
Information provided by (Responsible Party):
Muhammad Noman Karim, CMH RWP Combined Military Hospital RWP: Rawalpindi

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sensorineural Hearing Loss Tinnitus Drug: Combination Solution Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
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.
Masking: None (Open Label)
Masking Description: Care giver and patient both are known to the treatment being offered under investigation.
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Intra-Tympanic Methyl Prednisone-platelet Rich Plasma Combination in Sensorineural Hearing Loss and Tinnitus of Cochlear Origin.
Actual Study Start Date : September 1, 2023
Actual Primary Completion Date : September 30, 2023
Actual Study Completion Date : October 21, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Single Treated Arm
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..
Drug: Combination Solution
Methyl Prednisone (Trade name: SOLU-MEDROL) + Platelet rich Plasma (Autologous Biological product) via intra-tympanic rout about 1-1.5 ml.
Other Name: PRP + Solumedrol

Primary Outcome Measures :
  1. Improvement in Hearing [ Time Frame: 2 weeks post treatment completion. ]
    Improvement in hearing as per Audiogram, measured in decibels.

  2. Improvement in Tinnitus [ Time Frame: 2 weeks post treatment completion. ]
    Improvement in Tinnitus as per Visual analogue scale from 1 to 10 with 1 being the lowest improvement and 10 being the best.

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age: 10-70 yrs
  • Capacity to have a Pure tone Audiometry test
  • Disease

    1. SNHL;

      • Unilateral or bilateral sensorineural hearing loss
      • Without any identifiable cause
    2. Tinnitus;

      • Subjective sensation of noise without any obvious source of sound
      • Without any identifiable cause
  • Hearing levels of 55dB or above

Exclusion Criteria:

  • Age: less than 10 or more than 70 yrs
  • Conductive hearing loss/ Mixed Hearing loss
  • Tumor, Neurologic cause of hearing loss/ tinnitus
  • Past ear Surgery
  • Any External, middle or inner Ear Disease other than SSNHL
  • Traumatic Hearing Loss or Hearing Loss due to an obvious cause.
  • Patients' refusal to follow-up
  • Any contraindication to Steroids administration.
  • Any Blood Disorder
  • Non-consenting patients
  • Comorbid:

    • Diabetes
    • Hypertension
    • Cardio vascular diseases
    • Obesity
    • Etc.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT06025097

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Combined Military Hospital
Rawalpindi, Punjab, Pakistan, 75700
Sponsors and Collaborators
CMH RWP Combined Military Hospital RWP: Rawalpindi
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Study Director: Farhan Akbar, FCPS CMH Rawalpindi
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Responsible Party: Muhammad Noman Karim, Principal Investigator, Otolaryngology Dept, CMH Rawalpindi, CMH RWP Combined Military Hospital RWP: Rawalpindi Identifier: NCT06025097    
Other Study ID Numbers: 001
First Posted: September 6, 2023    Key Record Dates
Last Update Posted: February 22, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Muhammad Noman Karim, CMH RWP Combined Military Hospital RWP: Rawalpindi:
Platelet rich plasma
intratympanic steroids
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Methylprednisolone Hemisuccinate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents