An interventional study of Gastrodin Injection and Conventional Therapy in Sensorineural Hearing Loss and Vertigo, sponsored by The First Hospital of Hebei Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by The First Hospital of Hebei Medical University · Not applicable, Interventional, and Treatment
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.
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.
371 studies on the registry are indexed under Hearing Loss, Sensorineural; 112 are open to participants now.
This study's enrollment of 100 is above the median of 32 across 264 interventional studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →The First Hospital of Hebei Medical University is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Participants received conventional therapy plus Gastrodin Acupoint Injection (GAI).
Drug: Gastrodin Injection
Participants received conventional therapy only.
Drug: Conventional Therapy
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.
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.
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.
Time frame: 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.
Time frame: Baseline and Week 4
Change in Word Recognition Score (WRS)
WRS assesses speech discrimination ability by measuring the percentage of words correctly identified from a phonetically balanced list at a comfortable listening level (40 dB above speech reception threshold). Scores range from 0% to 100%. Higher scores indicate better hearing function and speech understanding.
Time frame: Baseline and Week 4
Change in Tinnitus Evaluation Questionnaire (TEQ) Score
The TEQ is used to assess the severity and impact of tinnitus on daily life. The questionnaire consists of items related to tinnitus characteristics and patient distress. Higher total scores indicate more severe tinnitus symptoms and a greater negative impact on the patient.
Time frame: Baseline and Week 4
Change in Hamilton Anxiety Scale (HAMA) Score
The HAMA is a clinician-rated scale to measure the severity of anxiety symptoms. It consists of 14 items, each scored from 0 to 4. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety.
Time frame: Baseline and Week 4
Change in Hamilton Depression Scale (HAMD) Score
The HAMD is a clinician-rated scale to measure the severity of depressive symptoms. It contains 17 or 24 items (depending on version used), with higher total scores indicating more severe depression.
Time frame: Baseline and Week 4
Change in Mean Flow Velocity (Vm) of Middle Cerebral Artery
Vm is measured using Transcranial Doppler (TCD) ultrasound in the middle cerebral artery. Measured in cm/s. In the context of ischemic pathology, an increase in Vm (within normal ranges) indicates improved cerebral blood perfusion.
Time frame: Baseline and Week 4
Change in Pulsatility Index (PI) of Middle Cerebral Artery
PI is a hemodynamic parameter measured using Transcranial Doppler (TCD) calculated as (Systolic Velocity - Diastolic Velocity) / Mean Velocity. It reflects downstream vascular resistance. A lower PI score indicates reduced vascular resistance and improved microcirculation.
Time frame: Baseline and Week 4
Change in Serum Endothelin-1 (ET-1) Level
Measurement of serum ET-1 levels via enzyme-linked immunosorbent assay (ELISA). ET-1 is a potent vasoconstrictor. Lower levels indicate reduced vasoconstriction and potentially improved microcirculation.
Time frame: Baseline and Week 4
Change in Serum Nitric Oxide (NO) Level
Measurement of serum NO levels via enzyme-linked immunosorbent assay (ELISA). NO is a vasodilator. Higher levels indicate improved vasodilation and endothelial function.
Time frame: Baseline and Week 4
Incidence of Adverse Events
Number of participants with adverse events including local pain, hematoma, or systemic reactions, assessed using CTCAE v5.0.
Time frame: From enrollment through study completion, an average of 4 weeks
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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The First Hospital of Hebei Medical University