Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss

Recruiting now · Not applicable

Conditions studied: Sudden Hearing Loss, Sensorineural Hearing Loss

In brief

This project aims to evaluate the clinical efficacy of Yiyuancong, an independently developed traditional Chinese medicine (TCM) formula based on the homology of medicine and food, in participants with sudden sensorineural hearing loss (SSNHL) and to elucidate its potential underlying mechanisms. This study is designed as a multicenter, randomized controlled trial (RCT), utilizing dynamic randomization for participant allocation. Due to the requirement for the experimental group to continuously administer the TCM preparation for 1-2 months, this study is conducted as an open-label (non-blinded) trial. All participants will undergo audiological evaluations at baseline, day 7 of treatment, and upon completion of the first and second treatment courses. Based on previous research regarding integrated traditional Chinese and Western medicine for SSNHL, the estimated effect size (ES) for the improvement of pure-tone thresholds compared with Western medicine alone ranges from 0.5 to 0.8. Assuming an effect size of 0.5 for the difference in pure-tone audiometry (PTA) improvement between the experimental and control groups, with a significance level (α) of 0.05 (one-tailed) and a statistical power (1-β) of 0.8, the required sample size calculated via G\*Power software is 51 per group. Accounting for a 20% dropout rate, the investigators plan to enroll 64 participants per group (total N = 128).

Key facts

Study ID

NCT07505667

Run by

Guangdong Provincial People's Hospital

People needed

128

Starts

2025-11-15

Expected to finish

2027-11-15

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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