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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals | Experimental |
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| Standard treatment | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard treatment combined with Yiyuancong | Drug | Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Pure-Tone Audiometry Hearing Threshold (dB HL) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Recognition Score (Word Recognition Percentage) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhuoyi Chen MD | Contact | +86 18737552662 | 18737552662@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D003639 | Hearing Loss, Sudden |
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Standard treatment | Drug | Standard treatment |
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| complete blood count (CBC) |
| baseline, and Day 7, Month 1, and Month 2 post-treatment. |
| Haematological index on kidney function | 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 | 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 | 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 | 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 |
| Shenzhen Baoan People's Hospital | Recruiting | Shenzhen | Guangdong | China |
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| Xiaolan People's Hospital of Zhongshan | Recruiting | Zhongshan | Guangdong | China |
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| Liuzhou Worker's Hospital | Recruiting | Liuzhou | Guangxi | China |
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| Guangdong Provincial People's Hospital Ganzhou Hospital | Recruiting | Ganzhou | Jiangxi | China |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |