Gastrodin Acupoint Injection for Sensorineural Hearing Loss With Vertigo

Hebei Medical University

Status: Completed

Conditions: Vertigo; Sensorineural Hearing Loss

Treatments: Drug: Gastrodin Injection; Drug: Conventional Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07283562

2022072

Details and patient eligibility

About

Sensorineural hearing loss (SNHL) accompanied by vertigo is a significant clinical challenge. Current conventional treatments often offer limited efficacy. This study evaluates the efficacy and safety of Gastrodin Acupoint Injection (GAI) as an adjunctive therapy based on the Traditional Chinese Medicine (TCM) theory of "treating both liver and heart." The trial compares the outcomes of patients receiving conventional therapy alone versus those receiving conventional therapy combined with GAI to determine improvements in auditory function, vestibular symptoms, and quality of life.

Full description

SNHL with vertigo significantly impacts patients' quality of life, often leading to psychological distress. The pathophysiology involves vascular compromise and inner ear hypoxia. While conventional treatments (corticosteroids, vasodilators) are standard, their efficacy can be inconsistent. TCM suggests that disharmony in the Liver and Heart contributes to these symptoms. Gastrodin, extracted from *Gastrodia elata*, has neuroprotective and circulation-promoting properties. Acupoint injection combines pharmacology with meridian stimulation.

This prospective, randomized, controlled trial enrolled 100 eligible patients assigned to either a GAI group or a Control group. Both groups received a standard regimen (Dextran-40, Ginkgo Biloba Extract, Mecobalamin, and Yufeng Ningxin Dripping Pills). The GAI group additionally received gastrodin injections at specific acupoints: Local points (Tinggong, Tinghui, Yifeng) and Distal points (Baihui, Taichong, Neiguan, Shenmen) alternating every two days for 4 weeks. Efficacy is assessed via audiometry, dizziness scales, tinnitus questionnaires, psychological scales, and hemodynamic/biomarker analysis.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meeting diagnostic criteria for SNHL with vertigo.
• Disease course of 3 to 30 days.
• Pure Tone Average (PTA) at 0.5, 1, 2, and 4 kHz between 30 and 90 dB HL.
• Willingness to participate and sign informed consent.

Exclusion criteria

• Conductive or mixed hearing loss.
• Hearing loss due to trauma, tumor, or infection.
• Meniere's disease.
• Severe systemic diseases (cardiovascular, cerebrovascular, renal, or hepatic).
• Pregnancy or lactation.
• Known allergy to any of the study medications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

GAI Group

Experimental group

Description:

Participants received conventional therapy plus Gastrodin Acupoint Injection (GAI).

Treatment:

Drug: Gastrodin Injection

Control Group

Active Comparator group

Description:

Participants received conventional therapy only.

Treatment:

Drug: Conventional Therapy