CAROVERINE Versus AMITRIPTYLINE in treatment of tinnitus

EFFICACY AND SAFETY OF CAROVERINE VERSUS AMITRIPTYLINE IN TREATMENT OF TINNITUS. - nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068528

Enrollment

120

Registered

2024-06-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: H931- Tinnitus

Interventions

Intervention1: AMITRIPTYLINE: 10MG ONE TAB ONCE DAILY FOR 1 MONTH Control Intervention1: CAROVERINE: 40mg TWICE daily for 1 month

Eligibility

Inclusion criteria

Inclusion criteria: The patients complaining of tinnitus affecting quality of life i.e. THI scoring more than 38. Idiopathic tinnitus

Exclusion criteria

Exclusion criteria: Vascular lesions of head and inner ear, ICSOL. Secondary causes of tinnitus. Eg.external ear and middle ear pathologies, patient on ototoxic drugs. Patients not willing to give written consent after receiving due instructions. Contra-indication for caroverine therapy (e.g. severe hypertension) Pregnancy or plan for having children Status post psychiatric therapy.

Design outcomes

Primary

Measure	Time frame
The change in the severity of tinnitus after treatment in patients with tinnitus according to THI scoring at 2 months. Timepoint: 8 Weeks	—

Secondary

Measure	Time frame
THI scoring at 1 month The safety of caroverine versus amitriptyline according to CTCAE (Common Terminology Criteria for Adverse Events) Timepoint: 1 MONTH	—

Countries

India

Contacts

Public ContactArchana mishra

kabikanta.samantaray@kims.ac.in9437080638

Outcome results

None listed

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