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Clinical trial Recruiting at 5 sites Interventional Ages 18 to 60

Yiyuancong treatment for sudden sensorineural hearing loss

Official title: Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss: A Multicenter, Randomized, Controlled Trial

Run by Guangdong Provincial People's Hospital · NCT07505667 · Data updated 2026-11-12

This trial will test whether adding Yiyuancong, a traditional Chinese medicine formula, to standard care helps adults with sudden sensorineural hearing loss recover more hearing.

Quick facts

Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment128 (estimated)
SponsorGuangdong Provincial People's Hospital
Academic / other
Locations5 sites (Guangzhou, Guangdong and 4 other locations)
StatusRecruiting
StartedNovember 15, 2025
Main results expectedNovember 15, 2027
Study endsNovember 15, 2027
Registry record updatedApril 1, 2026
Trial IDNCT07505667 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18–60 with unilateral SSNHL that began within 72 hours, a hearing threshold drop of at least 20 dB at two consecutive frequencies, able to enroll within 14 days and able to attend regular follow-up visits.

Probably not a fit

Patients who are pregnant or breastfeeding, have chronic ear disease, prior ear surgery, autoimmune hearing loss or Meniere's disease, recent corticosteroid use within 30 days, autoimmune or chronic inflammatory diseases, severe liver or kidney impairment, or other conditions judged unsuitable by investigators may not benefit and are excluded.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized controlled trial using dynamic randomization to assign participants to standard treatment with or without Yiyuancong, conducted openly because the TCM is taken continuously for 1–2 months. Participants are adults 18–60 with unilateral sudden sensorineural hearing loss presenting within 72 hours and enrolled within 14 days of onset. Audiological evaluations are scheduled at baseline, day 7 of treatment, and after completion of the first and second treatment courses to measure pure-tone threshold changes. The trial is being run at three hospitals in Guangdong province and builds on prior integrated TCM–Western medicine research that suggested moderate-to-large improvements in hearing.

Why it matters

Potential benefit: If successful, adding Yiyuancong to standard care could increase rates and extent of hearing recovery and reduce long-term hearing impairment.

How similar studies have gone: Previous studies combining traditional Chinese and Western medicine for SSNHL have reported moderate-to-large improvements in pure-tone thresholds (effect sizes ~0.5–0.8), so the approach has supportive evidence though Yiyuancong itself is being specifically tested.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Unilateral sudden sensorineural hearing loss (SSNHL) occurring within 72 hours, with a hearing threshold decrease of 20 dB at at least two consecutive frequencies.
2. Enrollment must be completed within 14 days of the onset of SSNHL.
3. Males or females aged 18 to 60 years.
4. Ability to understand the study protocol and comply with regular follow-up visits.

Exclusion Criteria:

1. Pregnancy or lactation (breastfeeding).
2. History of chronic ear disease, prior ear surgery, autoimmune hearing loss, or a confirmed diagnosis of Meniere's disease.
3. Receipt of corticosteroid therapy for any reason within the previous 30 days.
4. Presence of autoimmune diseases or chronic inflammatory diseases.
5. Severe hepatic or renal impairment.
6. Any other condition that, in the opinion of the investigator, renders the participant unsuitable for inclusion.

Where it's running

  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong, China     Recruiting
  • Shenzhen Baoan People's Hospital
    Shenzhen, Guangdong, China     Recruiting
  • Xiaolan People's Hospital of Zhongshan
    Zhongshan, Guangdong, China     Recruiting
  • Liuzhou Worker's Hospital
    Liuzhou, Guangxi, China     Recruiting
  • Guangdong Provincial People's Hospital Ganzhou Hospital
    Ganzhou, Jiangxi, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Sudden Hearing Loss 5Sensorineural Hearing Loss 36Guangdong Provincial People's Hospital 56
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.