Sensorineural Hearing Loss, Sudden Hearing Loss
Conditions
Brief summary
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).
Interventions
DRUGStandard treatment combined with Yiyuancong
Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals
DRUGStandard treatment
Standard treatment
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pure-Tone Audiometry Hearing Threshold (dB HL) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech Recognition Score (Word Recognition Percentage) | 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. |
| complete blood count (CBC) | baseline, and Day 7, Month 1, and Month 2 post-treatment. | — |
| Haematological index on kidney function | 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. |
| Haematological index on liver function | 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. |
| Fecal composition analysis | 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 |
| Peripheral venous blood composition analysis | 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. |
Countries
China
Contacts
CONTACTZhuoyi Chen MD
Outcome results
None listed