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NCT Number: NCT07235488

Effectiveness of Integrative Medical Treatment in Sudden Hearing Loss

Sudden hearing loss is an emergency in otolaryngology that requires diagnosis and treatment as soon as possible. The golden treatment period is two weeks since the onset of the disease. However, modern medicine is still unable to fully understand the causes of the disease and in lack of corresponding effective treatments. Current therapies also have their own limitations and side effects. To find an effective and safe treatment, integrating with modern medicine and providing inpatient and outpatient medical care, is an important issue in clinical care. Traditional Chinese medicine has been clinically utilized for a long time with accumulated empirical experience and evidence for its efficacy. It can be used as an alternative therapeutic option for sudden hearing loss.

Being with a long period of clinical experience and evidence-based curative effect, acupuncture could be applied as an adjunctive treatment for the sudden hearing loss. Currently, this patient-centered, pragmatic clinical trial compares the effectiveness of using west medicine、combination of west medicine and traditional Chinese medicine. The aim of this study is to explore acceptable and beneficial strategy to reduce the clinical symptoms, to improve quality of life, and decrease medical expenses.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, Taiwan

Location status: Recruiting

Location contact

Ming-Cheng Huang, M.D., Ph.D.

CONTACT

[email protected]

+886-4-22052121 Ext. 14561

About this study

Patients newly diagnosed with sudden deafness were randomly assigned in a 1:1 ratio to two groups: a Western medicine group and an integrated Chinese and Western medicine treatment group. Each group included 32 patients, for a total of 64 patients. Treatment lasted four weeks, starting from the date of admission, and included both inpatient and outpatient care.

Western Medicine Treatment: During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed.

Traditional Chinese Medicine Treatment: Acupuncture was performed once daily for 30 minutes at acupoints around the ear and upper limb on the same side as the affected ear. Six treatment sessions were performed in the first and second weeks, and two sessions were performed in the third and fourth weeks.

Primary Outcome: Pure-tone audiograms were performed at baseline, week 1, week 2, and week 4.

Secondary Outcome: Tinnitus Handicap Inventory and Dizziness Handicap Inventory were performed at baseline, week 1, week 2, and week 4. Blood biochemistry tests were performed at baseline. Adverse events were recorded throughout the trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years, both male and female.
  • Meeting the diagnostic criteria for sudden sensorineural hearing loss (SSNHL), defined as hearing loss of >30 dB affecting at least three consecutive frequencies within 3 days.
  • Newly onset of hearing loss within 2 week.
  • Fully understanding the purpose and procedures of the study and providing signed informed consent.

Exclusion criteria

  • Central nervous system lesions such as vestibular schwannoma or traumatic brain injury.
  • Middle ear or retrocochlear pathology.
  • History of otologic surgery.
  • Hemorrhagic disorders or coagulation abnormalities.
  • Inability to cooperate with examinations due to dementia or psychiatric illness.
  • Previous treatment for SSNHL on the same affected side within the past 6 months.

Treatment and study plan

acupuncture

Device

Treatment lasted four weeks, starting from the date of admission, and included both inpatient and outpatient care.

Western Medicine Treatment : During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed.

Traditional Chinese Medicine Treatment : Acupuncture was performed on peri-auricular and ipsilateral upper limb points, including Ermen (TE21), Tinggong (SI19), Tinghui (GB2), Shuaigu (GB8), Yifeng (TE17), Waiguan (TE5), and Zhongzhu (TE3). The treatment was administered once daily for 30 minutes. During the first and second weeks, a total of six sessions were carried out, followed by two sessions per week in the third and fourth weeks.

Steroid Therapy

Drug

Treatment lasted four weeks, starting from the date of admission, and included both inpatient and outpatient care.

Western Medicine Treatment : During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed.

Primary outcomes

  1. Pure-tone audiograms

    Time frame: baseline, week 1, week 2, and week 4

    Changes from baseline to week 1, week 2, and week 4 of the intervention

Secondary outcomes

  1. Tinnitus Handicap Inventory

    Time frame: baseline, week 1, week 2, and week 4

    Changes from baseline to week 1, week 2, and week 4 of intervention

  2. Dizziness Handicap Inventory

    Time frame: baseline, week 1, week 2, and week 4

    Changes from baseline to week 1, week 2, and week 4 of intervention

  3. Blood examination

    Time frame: baseline

    neutrophil-to-lymphocyte ratio (NLR)

  4. Laboratory examination

    Time frame: baseline

    inflammatory cytokine test (IL-1β, IL-6, TNF-α)

  5. Adverse events

    Time frame: baseline, week 1, week 2, and week 4

    Adverse events related to steroid or acupuncture therapy were recorded throughout the trial.

Study contacts

Contact information is provided by the study sponsor or research team.

Ming-Cheng Huang, M.D., Ph.D.

CONTACT

[email protected]

+886-4-22052121 Ext. 14561

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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