NCT07283562

Gastrodin Acupoint Injection for Sensorineural Hearing Loss With Vertigo

Efficacy and Safety of Gastrodin Acupoint Injection as an Adjunctive Therapy for Sensorineural Hearing Loss With Vertigo: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: The First Hospital of Hebei Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Sensorineural Hearing Loss
• Vertigo

Interventions

Type	Name	Description
DRUG	Gastrodin Injection	0.5 mL (25 mg) gastrodin injected into selected acupoints alternating between Set A (Tinggong, Tinghui, Yifeng) and Set B (Baihui, Taichong, Neiguan, Shenmen) once every two days for 4 weeks. Conventional therapy included: IV Dextran-40 (7 days), IV Ginkgo Biloba (14 days), oral Mecobalamin, and oral Yufeng Ningxin Dripping Pills.
DRUG	Conventional Therapy	Intravenous Dextran-40 (500 mL, daily for 7 days); Intravenous Ginkgo Biloba Extract (20 mL, daily for 14 days); Oral Mecobalamin tablets (0.5 mg, t.i.d.); Oral Yufeng Ningxin Dripping Pills (12 pills, t.i.d.) for 4 weeks. No sham injections were administered.

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

1 site across 1 country: China