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Assessment of the effect of rivaroxaban on sudden sensorineural hearing loss

Assessment of the effect of rivaroxaban as Adjuvant Treatment for improvement of Idiopathic Sudden Sensorineural Hearing Loss

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200708048051N1
Enrollment
140
Registered
2020-08-01
Start date
2020-08-22
Completion date
Unknown
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Sudden Sensorineural Hearing Loss. Sudden idiopathic hearing loss, unspecified ear

Interventions

Intervention 1: Intervention group: Prednisolone (Nisopred ®, Iranhormone Co.) tablets at a dose of 1 mg / kg daily (maximum 60 mg as a single dose in the morning) for 10 days and then taper for 5 day

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with a unilateral sudden sensory hearing loss Refer to the hospital in less than 5 days from the onset of symptoms Hearing loss of = 30 dB at least 3 consecutive frequencies in the audiometery.

Exclusion criteria

Exclusion criteria: Patients with a history of hearing loss, trauma to the ear, active ear infection, congenital cochlear disease Use of ototoxic drugs, anticoagulants, anticonvulsants. Cardiovascular disease, coagulation disorders, and diabetes. Retro cochlear lesions Severe renal and hepatic impairment (Cr clearance less than 15) People with neoplasms who have not been treated or are being treated with chemotherapy or radiotherapy. pregnancy and breastfeeding Patients with history of autoimmune disorder Patients with platelet count disorder (less than 150,000)

Design outcomes

Primary

MeasureTime frame
Hearing threshold. Timepoint: Before starting treatment and 2 weeks after and 3 months after starting treatment. Method of measurement: Pure tone audiometry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mir Mohammad Jalali

Rasht University of Medical Sciences

mmjalali@gmail.com+98 13 3322 5242

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026