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NCT07505667

Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss

Recruiting now NA Last updated 1 April 2026
What this trial tests

NA trial testing Standard treatment combined with Yiyuancong in Sudden Hearing Loss in 128 participants. Currently enrolling.

Timeline
15 November 2025
Primary endpoint
15 November 2027
15 November 2027

Quick facts

Lead sponsorGuangdong Provincial People's Hospital
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment128
Start date15 November 2025
Primary completion15 November 2027
Estimated completion15 November 2027
Sites5 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Guangdong Provincial People's Hospital

Who can join

Adults 18 to 60, any sex, with Sudden Hearing Loss or Sensorineural Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Sudden Hearing Loss

Currently open trials in the same condition.

Other Guangdong Provincial People's Hospital trials

Trials by the same sponsor.

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Data sources for this page

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