Gastrodin Acupoint Injection for Sensorineural Hearing Loss With Vertigo

NCT07283562 | Completed

• 1 other identifier: 2022072
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vertigo; Sensorineural Hearing Loss

Outcome Measures

Primary Outcomes (2)

• Change in Pure Tone Average (PTA)

  Calculated as the average of air-conduction hearing thresholds at 0.5, 1, 2, and 4 kHz measured by audiometry.

  Baseline and Week 4

• Change in Dizziness Handicap Inventory (DHI) Score

  The DHI is a 25-item self-assessment questionnaire evaluating the functional, emotional, and physical impact of dizziness. The total score ranges from 0 to 100. Higher scores indicate greater perceived handicap and more severe dizziness symptoms.

  Baseline and Week 4

Secondary Outcomes (9)

• Change in Word Recognition Score (WRS)

  Baseline and Week 4

• Change in Tinnitus Evaluation Questionnaire (TEQ) Score

  Baseline and Week 4

• Change in Hamilton Anxiety Scale (HAMA) Score

  Baseline and Week 4

• Change in Hamilton Depression Scale (HAMD) Score

  Baseline and Week 4

• Change in Mean Flow Velocity (Vm) of Middle Cerebral Artery

  Baseline and Week 4

Study Arms (2)

GAI Group

EXPERIMENTAL

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

Drug: Gastrodin Injection

Control Group

ACTIVE COMPARATOR

Participants received conventional therapy only.

Drug: Conventional Therapy

Interventions

Conventional Therapy 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.

Control Group

Gastrodin Injection 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.

GAI Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

The First Hospital of Zhangjiakou

Zhangjiakou, Hebei, 075000, China

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Vertigo

Interventions

gastrodin

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vestibular Diseases; Labyrinth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 16, 2025
• Study Start: January 1, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

CN (1)