Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss

March 26, 2026 updated by: Xiong hao, Guangdong Provincial People's Hospital

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard treatment
Drug: Standard treatment
Standard treatment
Experimental: Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals
Drug: Standard treatment combined with Yiyuancong
Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pure-Tone Audiometry Hearing Threshold (dB HL)
Time Frame: baseline (day of enrollment), and Day 7, Month 1, and Month 2 post-treatment.
Change in hearing threshold levels measured in decibels hearing level (dB HL) across standard audiometric frequencies (0.25-8 kHz) using calibrated pure-tone audiometry. Lower dB HL values indicate improved auditory sensitivity.
baseline (day of enrollment), and Day 7, Month 1, and Month 2 post-treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech Recognition Score (Word Recognition Percentage)
Time Frame: baseline, and Day 7, Month 1, and Month 2 post-treatment.
Speech recognition ability measured using standardized word recognition testing (e.g., NU-6 word lists). Scores range from 0-100%, with higher scores indicating better speech discrimination ability.
baseline, and Day 7, Month 1, and Month 2 post-treatment.
complete blood count (CBC)
Time Frame: baseline, and Day 7, Month 1, and Month 2 post-treatment.
baseline, and Day 7, Month 1, and Month 2 post-treatment.
Haematological index on kidney function
Time Frame: baseline, Month 1, and Month 2 post-treatment.
The investigators assess the changes in haematological index on kidney function levels compared to the baseline. The indicators for evaluating kidney function include biochemical parameters such as serum creatinine, urea nitrogen, uric acid, glomerular filtration rate, and urine protein.
baseline, Month 1, and Month 2 post-treatment.
Haematological index on liver function
Time Frame: baseline, Month 1, and Month 2 post-treatment.
The investigators assess the changes in haematological index on liver function and kidney function levels compared to the baseline. The indicators for evaluating liver function include biochemical indicators such as albumin, transaminases, and bilirubin.
baseline, Month 1, and Month 2 post-treatment.
Fecal composition analysis
Time Frame: baseline, and Month 2 post-treatment.
16S rDNA sequencing and bioinformatic analysis were performed on fecal samples collected before and after treatment to identify significantly altered gut microbiota. By comparing microbial diversity, abundance, and function across these time points, the regulatory effects of the Yiyuancong compound on the intestinal microecology were preliminarily explored
baseline, and Month 2 post-treatment.
Peripheral venous blood composition analysis
Time Frame: Baseline, Month 1 and Month 2 post-treatment
Liquid chromatography-mass spectrometry (LC-MS) was employed to perform qualitative and quantitative analysis of the active constituents and metabolites in the patients' plasma. By integrating the results of metabolomics and transcriptomics, the primary active components and potential biological targets of the Yiyuancong compound were further validated.
Baseline, Month 1 and Month 2 post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2025

Primary Completion (Estimated)

November 15, 2027

Study Completion (Estimated)

November 15, 2027

Study Registration Dates

First Submitted

March 21, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2026-115-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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