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Efficacy of different doses of ginkgo biloba extract tablets in treating tinnitus after sudden sensorineural hearing loss: a multicenter, randomized, open-label, controlled clinical trial

Efficacy of different doses of ginkgo biloba extract tablets in treating tinnitus after sudden sensorineural hearing loss: a multicenter, randomized, open-label, controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025178
Enrollment
Unknown
Registered
2019-08-15
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

Sudden Hearing Loss

Interventions

High-dose Group:ginkgo biloba extract tablets, 80mg tid p.o.
Low-dose Group:ginkgo biloba extract tablets, 40mg tid p.o.

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 65 years; 2) With new-onset unilateral idiopathic sudden sensorineural hearing loss (SSNHL), and having a reduction in hearing >= 30dB in at least three consecutive frequencies compared with the contralateral ear in pure tone audiometry; 3) Whose contralateral ear functions normally, or has age-related hearing reduction*; 4) Having SSNHL for = grade 2, i.e. >= 18 points; 6) Without a history of tinnitus in both ears; 7) Without a history of ear conditions which may affect hearing; 8) Who signed the informed consent; 9) With follow-up compliance; * The criteria of age-related hearing reduction are: 18 <= age <65: PTA <= 25dB; 55 <=age < 60: PTA <= 35dB; 60 <= age < 65: PTA <= 40dB.

Exclusion criteria

Exclusion criteria: 1) With SSNHL with known cause; 2) Who were taking oral microcirculation-improving drugs or took them within three months before the trail, including but not limited to ginkgo leaf tablets, ginkgo biloba extract drops, Xuesaitong, Xueshuantong, lumbrokinase and prostaglandin tablets; 3) With severe comorbidities such as severe heart disease, cerebral infarction, poorly controlled hypertension, coagulation abnormalities, malignancies, heart failure, arrhythmia, conditions requiring hemodialysis, HBV, HCV and dementia; 4) Who are pregnant or plan to become pregnant in 12 months; 5) With a history of diagnosed depression, anxiety or mental disorders; 6) With a history of diagnosed immune-related diseases; 7) Without a complete medical record.

Design outcomes

Primary

MeasureTime frame
Tinnitus handicap inventory;Visual Analogue Scale of Tinnitus;

Secondary

MeasureTime frame
Threshold of Pure Tone Audiometry;

Countries

China

Contacts

Public ContactYu Lisheng

Department of Otolaryngology, Peking University People's Hospital

yulish68@163.com+86 13910750400

Outcome results

None listed

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