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Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss

RecruitingNAAges 18 Years - 60 YearsAllGuangdong Provincial People's Hospital
NCT07505667 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Standard treatment combined with Yiyuancong
  • Standard treatment
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Where

5 sites
Guangdong Provincial People's Hospital
Guangzhou, China
Shenzhen Baoan People's Hospital
Shenzhen, China
Xiaolan People's Hospital of Zhongshan
Zhongshan, China
Liuzhou Worker's Hospital
Liuzhou, China
Guangdong Provincial People's Hospital Ganzhou Hospital
Ganzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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