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Ginkgo biloba combined with prednisone acetate tablets for the treatment of tinnitus after cochlear implantation: A randomized controlled trial

Ginkgo biloba combined with prednisone acetate tablets for the treatment of tinnitus after cochlear implantation: A randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108098
Enrollment
Unknown
Registered
2025-08-25
Start date
2025-08-10
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Tinnitus after cochlear implant surgery

Interventions

Experimental group:Ginkgo bilobaand Prednisone Acetate Tablets
Positive control group:Prednisone Acetate Tablets
Blank group:None

Sponsors

Shandong Second Provincial General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years old (including 18 years old and 70 years old); 2. Unilateral cochlear implant implantation surgery completed by the clinical treatment team; 3. Preoperative tinnitus course >=3 months; 4. On the second day after surgery, the THI, TFI and VAS scores were all aggravated compared with before. 5. No obvious abnormalities in blood analysis and liver and kidney function tests; 6. Sufficient written or speaking skills (or able to participate in research activities with the assistance of a guardian) and willing to comply with the study protocol; 7. Able to complete the online study questionnaire using a computer or other suitable device with Internet access.

Exclusion criteria

Exclusion criteria: 1. Patients with existing cochlear implants; 2. Patients under 18 years old; 3. Those who have significantly reduced or disappeared tinnitus after surgery; 4. Psychiatric tinnitus or antidepressant drug users; 5. Concomitant use of other anti-tinnitus drugs; 6. Those with severe cognitive impairment or neurological diseases; 7. Those with contraindications to Kinnadol (such as allergies or coagulation mechanism disorders); 8. Other conditions that the investigator deems unsuitable.

Design outcomes

Primary

MeasureTime frame
Tinnitus Functional Index (TFI);The Tinnitus Handicap Inventory (THI);

Secondary

MeasureTime frame
Generalized Anxiety Disorder (GAD-7);Visual Analogue Scale (VAS);Patient Health Questionnaire (PHQ-9);Insomnia Severity Index (ISI);

Countries

China

Contacts

Public ContactJianfen Luo

Shandong Provincial Second People's Hospital

luojianfen1979@163.com+86 531 83086268

Outcome results

None listed

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