Yiyuancong treatment for sudden sensorineural hearing loss

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (Academic / other)
• Locations: 5 sites (Guangzhou, Guangdong and 4 other locations)
• Trial ID: NCT07505667 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Guangzhou, Guangdong and 4 other locations

• 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

• Study coordinator: Zhuoyi Chen MD

Conditions Sudden Hearing Loss; Sensorineural Hearing Loss