Sensorineural Hearing LossNCT07283562
Gastrodin Acupoint Injection for Sensorineural Hearing Loss With Vertigo
A study testing Gastrodin Injection and Conventional Therapy in people with Sensorineural Hearing Loss and Vertigo, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sensorineural Hearing Loss, Vertigo
- What is being tested?
- Gastrodin Injection and Conventional Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Gastrodin Acupoint Injection as an Adjunctive Therapy for Sensorineural Hearing Loss With Vertigo: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Gastrodin Injection, Conventional Therapy
- Medical subject headings
- Hearing Loss, Sensorineural, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrodin InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| GAI Group | Experimental | Participants received conventional therapy plus Gastrodin Acupoint Injection (GAI). Receives: Drug: Gastrodin Injection |
| Control Group | Active comparator | Participants received conventional therapy only. Receives: Drug: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and Week 4
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Jan 2023
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Yuan, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283562
- Sponsor's protocol ID
- 2022072
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Gastrodin Acupoint Injection as an Adjunctive Therapy for Sensorineural Hearing Loss With Vertigo: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07283562
- Acronym / sponsor ID
- 2022072
- Conditions
- Sensorineural Hearing Loss, Vertigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GAI Group | Experimental | Drug: Gastrodin InjectionParticipants received conventional therapy plus Gastrodin Acupoint Injection (GAI). |
| Control Group | Active comparator | Drug: Conventional TherapyParticipants received conventional therapy only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastrodin Injection0.5 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 | GAI Group |
| Conventional TherapyIntravenous 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. | Drug | Control Group |
Primary outcome
Change in Pure Tone Average (PTA)
Time frame: Baseline and Week 4
Calculated as the average of air-conduction hearing thresholds at 0.5, 1, 2, and 4 kHz measured by audiometry.
Change in Dizziness Handicap Inventory (DHI) Score
Time frame: Baseline and Week 4
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.
9 secondary outcomes
Change in Word Recognition Score (WRS)
Time frame: Baseline and Week 4
Change in Tinnitus Evaluation Questionnaire (TEQ) Score
Time frame: Baseline and Week 4
Change in Hamilton Anxiety Scale (HAMA) Score
Time frame: Baseline and Week 4
Change in Hamilton Depression Scale (HAMD) Score
Time frame: Baseline and Week 4
Change in Mean Flow Velocity (Vm) of Middle Cerebral Artery
Time frame: Baseline and Week 4
Change in Pulsatility Index (PI) of Middle Cerebral Artery
Time frame: Baseline and Week 4
Change in Serum Endothelin-1 (ET-1) Level
Time frame: Baseline and Week 4
Change in Serum Nitric Oxide (NO) Level
Time frame: Baseline and Week 4
Incidence of Adverse Events
Time frame: From enrollment through study completion, an average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastrodin Injection and Conventional Therapy in people with Sensorineural Hearing Loss and Vertigo, run by The First Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pure Tone Average (PTA) (time frame: Baseline and Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.