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

NCT06025097 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-02-22

No results posted yet for this study

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.

Conditions

  • Sensorineural Hearing Loss
  • Tinnitus

Interventions

DRUG

Combination Solution

Methyl Prednisone (Trade name: SOLU-MEDROL) + Platelet rich Plasma (Autologous Biological product) via intra-tympanic rout about 1-1.5 ml.

Sponsors & Collaborators

  • CMH RWP Combined Military Hospital RWP: Rawalpindi

    lead OTHER_GOV

Principal Investigators

  • Farhan Akbar, FCPS · CMH Rawalpindi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2023-09-30
Completion
2023-10-21
FDA Drug
Yes

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06025097 on ClinicalTrials.gov