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Multicenter, open, randomized, controlled clinical study of different doses of Extract of Ginkgo Biloba Leaves Tablets on tinnitus after sudden deafness

Multicenter, open, randomized, controlled clinical study of different doses of Extract of Ginkgo Biloba Leaves Tablets on tinnitus after sudden deafness

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043374
Enrollment
Unknown
Registered
2021-02-12
Start date
2020-09-01
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Tinnitus

Interventions

Experimental Group:Oral quinadol 80mg, TID
control group:Oral quinadol 80mg, TID

Sponsors

The Second People's Hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 65 years; 2) The first episode of unilateral idiopathic sudden deafness, PTA decreased >= 30dB in 3 consecutive frequencies at least compared with the contralateral ear; 3) Normal hearing in the contralateral ear, or age-appropriate hearing loss; 4) The course of sudden deafness is less than 3 months; 5) The THI score of new tinnitus on the same side after sudden deafness was higher than Grade 2 (including Grade 2), that is, 18 points or above; 6) No previous bilateral history of tinnitus; 7) No previous history of bilateral ear diseases affecting hearing; 8) Signed the informed consent; 9) Follow-up can be maintained.

Exclusion criteria

Exclusion criteria: 1) Sudden deafness of any definite cause; 2) Other oral drugs for improving microcirculation had been used or were being used within 3 months before enrollment, including but not limited to: Ginkgo biloba leaves, Ginkgo biloba extracts drops, Xuesetone, Lumbrokinase, prostatin tablets, etc 3) Patients with severe heart disease, cerebral infarction, cerebral hemorrhage, poorly controlled hypertension, abnormal coagulation, malignant disease, heart failure, arrhythmia, hemodialysis, HBV, HCV, dementia and other serious diseases; 4) Patients with hyperlactic disease, methanol addiction, poor tolerance of fructose sorbitol and 1,6 diphosphate fructosase deficiency; 5) Women who are pregnant or preparing to become pregnant within 12 months; 6) People with previous definite diagnosis of depression, anxiety or mental disorder; 7) Past immune-related diseases with clear diagnosis; 8) The clinical examination data cannot be kept completely;

Design outcomes

Primary

MeasureTime frame
Tinnitus VAS score;Absolute change in tinnitus THI score;

Countries

China

Contacts

Public ContactYu Yanping

The Second People's Hospital of Shenzhen

49375621@qq.com+86 13425101836

Outcome results

None listed

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