Status:
COMPLETED
Intra-Tympanic Steroid With PRP Combination in Sensorineural Hearing Loss and Tinnitus.
Lead Sponsor:
CMH RWP Combined Military Hospital RWP: Rawalpindi
Conditions:
Sensorineural Hearing Loss
Tinnitus
Eligibility:
All Genders
10-70 years
Phase:
EARLY_PHASE1
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 lim...
Detailed Description
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 af...
Eligibility Criteria
Inclusion
- Age: 10-70 yrs
- Capacity to have a Pure tone Audiometry test
- Disease
- SNHL;
- Unilateral or bilateral sensorineural hearing loss
- Without any identifiable cause
- Tinnitus;
- Subjective sensation of noise without any obvious source of sound
- Without any identifiable cause
- Hearing levels of 55dB or above
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06025097
Start Date
September 1 2023
End Date
October 21 2023
Last Update
February 22 2024
Active Locations (1)
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1
Combined Military Hospital
Rawalpindi, Punjab Province, Pakistan, 75700