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Gastrodin Acupoint Injection for Sensorineural Hearing Loss With Vertigo

NCT ID: NCT07283562

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-10-31

Brief Summary

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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

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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

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Sensorineural Hearing Loss Vertigo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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GAI Group

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

Group Type EXPERIMENTAL

Gastrodin Injection

Intervention Type DRUG

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.

Control Group

Participants received conventional therapy only.

Group Type ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Hospital of Hebei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Wu Yuan

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Hospital of Zhangjiakou

Zhangjiakou, Hebei, China

Site Status

Countries

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China

Other Identifiers

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2022072

Identifier Type: -

Identifier Source: org_study_id