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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals
Standard treatment
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGShenzhen Baoan People's Hospital
Shenzhen, Guangdong, China
RECRUITINGXiaolan People's Hospital of Zhongshan
Zhongshan, Guangdong, China
RECRUITINGLiuzhou Worker's Hospital
Liuchow, Guangxi, China
RECRUITINGGuangdong Provincial People's Hospital Ganzhou Hospital
Ganzhou, Jiangxi, China
RECRUITINGChange 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.
Time frame: baseline (day of enrollment), and Day 7, Month 1, and Month 2 post-treatment.
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.
Time frame: 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.
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline, Month 1 and Month 2 post-treatment
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