Intra-Tympanic Steroid With PRP Combination in Sensorineural Hearing Loss and Tinnitus.
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|ClinicalTrials.gov Identifier: NCT06025097|
Recruitment Status : Recruiting
First Posted : September 6, 2023
Last Update Posted : September 21, 2023
|Condition or disease||Intervention/treatment||Phase|
|Sensorineural Hearing Loss Tinnitus||Drug: Combination Solution||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|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.|
|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|
|Estimated Primary Completion Date :||September 30, 2023|
|Estimated Study Completion Date :||October 21, 2023|
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
- Improvement in Hearing [ Time Frame: 2 weeks post treatment completion. ]Improvement in hearing as per Audiogram, measured in decibels.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT06025097
|Contact: Muhammad Noman Karim, MBBSemail@example.com|
|Contact: Muhammad Noman, FCPSfirstname.lastname@example.org|
|Combined Military Hospital||Recruiting|
|Rawalpindi, Punjab, Pakistan, 75700|
|Contact: Muhammad Noman Karim, FCPS email@example.com|
|Study Director:||Farhan Akbar, FCPS||CMH Rawalpindi|