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A multi-center, prospective clinical study for the safety and efficacy of Yuekangtong (extract of ginkgo biloba leaves) Injection in the treatment of acute primary subjective tinnitus

A multi-center, prospective, real-world clincal study for the therapeutic efficacy of Yuekangtong extract of ginkgo biloba leaves injection in the treatment of acute primary subjective tinnitus

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070807
Enrollment
Unknown
Registered
2023-04-24
Start date
2022-05-24
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Acute primary subjective tinnitus

Interventions

Yuekangtong extract of ginkgo biloba leaves injection group:none

Sponsors

Beijing Tongren Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.When signing the informed consent form, the age of subject is 18-65 years old (including 18 and 65 years old), either gender; 2.The subject of acute primary subjective tinnitus; (1) The course of disease is within 3 months; (2) Without definite disease (including the whole or part bodys' reason); (3) The tinnitus is only heard by subject; (4) With or without hearing loss. 3.The subject signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1.The subject with External middle ear lesions, Meniere's disease, acoustic neuroma and large vestibular aqueduct syndrome etc; 2.The subject with severe heart disease, coagulation or platelet dysfunction, bleeding tendency, severe liver or kidney dysfunction [ALT or AST > 2.0 ULN, and/or serum creatinine > 2.0 ULN], and serious diseases affecting their survival; 3.The subject with severe mental illness, severe cognitive dysfunction and so on, couldn't or is unwilling to cooperate; 4.The subject is allergic to the study drug or with medical history of serious adverse reaction; 5.Pregnant women, women planning pregnancy or lactating women; 6.The subject who the investigator considers is not suitable to this clinical study.

Design outcomes

Primary

MeasureTime frame
Tinnitus Handicap Inventory (THI);

Secondary

MeasureTime frame
Hospital Anxiety and Depression Scale (HADS);Adeverse events;

Countries

China

Contacts

Public ContactHan Demin; Huang Zhigang; Li Yongxin

Beijing Tongren Hospital, CMU

entlyx@sina.com+86 10 5826 9911

Outcome results

None listed

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