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Ancient herb tested for hearing loss in seniors

NCT ID NCT05125081

Disease control Sponsor: Shanghai Jiao Tong University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a traditional Chinese herbal pill called Liuwei Dihuang Pill can improve hearing in older adults with age-related hearing loss. 120 people aged 65-75 took either the pill or a placebo for 48 weeks. Researchers measured changes in speech recognition to see if the pill helps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Liuwei Dihuang Pill (a traditional Chinese herbal pill)
What this could lead to
If it works, this could point toward a treatment to slow or improve age-related hearing loss.
What could go wrong
This is a small, early phase 2 trial with only 120 participants. The herbal pill may not work better than placebo, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

120 people

The number who actually took part.

Started

Jan 2022

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects must have a current diagnosis of presbyacusis with symmetrical hearing loss, defined as 15-dB or less difference in pure tone average between ears at 0.5, 1, 2 and 4kHz. The average hearing threshold loss level is mild or moderate (20 ≤ average hearing threshold \< 50 dBHL). 2. Adult aged 65-75 years inclusive. 3. Maximum speech recognition rate in quiet environment is equal to or over 60% with ability to communicate well. 4. Subjects have no cognitive impairment with CDR score =0. 5. Subjects must have a current diagnosis of Shen (Kidney)-Yin Deficiency. 6. Subjects have read and voluntarily signed the Informed Consent Form (ICF) after all questions have been answered and prior to any study-mandated procedure. Exclusion Criteria: 1. Subjects with sudden hearing loss or pure tone hearing fluctuation within the three months. 2. Subjects with a history of serious mental illness. 3. Subjects with severe cardiac insufficiency, malignant tumor or other serious systemic diseases. 4. Subjects with conductive deafness, congenital deafness, hereditary deafness, inner ear immune and autoimmune inner ear diseases, auditory neuropathy, toxic deafness and noise deafness. 5. Subjects with organic ear diseases, abnormal ear structure and symptomatic cerebral infarction. 6. Subjects with dementia, neurosyphilis, hypothyroidism and depression. 7. Subjects has previously participated in other clinical trial within the three months. 8. Subjects with using hearing aids or devices. 9. Other situations where the researcher thinks it is inappropriate to participate in this research.

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Conditions

The condition(s) this trial relates to.

Deafness hearing disorder hearing loss disorder presbycusis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Age related hearing loss Hearing disorders and deafness Presbycusis

Contacts and locations

Locations

  • Community Health Service Center of North Sichuan Road, Hongkou District, Shanghai

    Shanghai, Shanghai Municipality, 200081, China

  • Community Health Service Center of Tianlin Street, Xuhui District, Shanghai

    Shanghai, Shanghai Municipality, 200233, China

  • Jiaxing Street Community Health Service Center, Hongkou District, Shanghai

    Shanghai, Shanghai Municipality, 200086, China

  • Juquan New Town Community Health Service Center, Gucun Town, Baoshan District, Shanghai

    Shanghai, Shanghai Municipality, 201907, China

  • Sixth people's Hospital Affiliated to Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200233, China

  • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 200437, China

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