Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard treatment combined with Yiyuancong, Standard treatment.
- Who it may be relevant to
- Registry conditions: Sudden Hearing Loss, Sensorineural Hearing Loss. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss: A Multicenter, Randomized, Controlled Trial
Overview
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
- Drug Standard treatment combined with Yiyuancong
Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals - Drug Standard treatment
Standard treatment
Primary outcome measures
- 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.]
Secondary outcome measures (6)
- Speech Recognition Score (Word Recognition Percentage) [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 [Time frame: baseline, Month 1, and Month 2 post-treatment.]
- Haematological index on liver function [Time frame: baseline, Month 1, and Month 2 post-treatment.]
- Fecal composition analysis [Time frame: baseline, and Month 2 post-treatment.]
- Peripheral venous blood composition analysis [Time frame: Baseline, Month 1 and Month 2 post-treatment]
Eligibility criteria
Inclusion criteria
- Unilateral sudden sensorineural hearing loss (SSNHL) occurring within 72 hours, with a hearing threshold decrease of 20 dB at at least two consecutive frequencies.
- Enrollment must be completed within 14 days of the onset of SSNHL.
- Males or females aged 18 to 60 years.
- Ability to understand the study protocol and comply with regular follow-up visits.
Exclusion criteria
- Pregnancy or lactation (breastfeeding).
- History of chronic ear disease, prior ear surgery, autoimmune hearing loss, or a confirmed diagnosis of Meniere's disease.
- Receipt of corticosteroid therapy for any reason within the previous 30 days.
- Presence of autoimmune diseases or chronic inflammatory diseases.
- Severe hepatic or renal impairment.
- Any other condition that, in the opinion of the investigator, renders the participant unsuitable for inclusion.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 5 centers
- Guangdong Provincial People's Hospital — Guangzhou
- Shenzhen Baoan People's Hospital — Shenzhen
- Xiaolan People's Hospital of Zhongshan — Zhongshan
- Liuzhou Worker's Hospital — Liuzhou
- Guangdong Provincial People's Hospital Ganzhou Hospital — Ganzhou
Identifiers
NCT: NCT07505667 · KY2026-115-01