Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss

NCT07505667 | Recruiting

• 1 other identifier: KY2026-115-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 5

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).

Conditions

Sensorineural Hearing Loss; Sudden Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• Speech Recognition Score (Word Recognition Percentage)

  baseline, and Day 7, Month 1, and Month 2 post-treatment.

• 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.

• Haematological index on liver function

  baseline, Month 1, and Month 2 post-treatment.

• Fecal composition analysis

  baseline, and Month 2 post-treatment.

Study Arms (2)

Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals

EXPERIMENTAL

Drug: Standard treatment combined with Yiyuancong

Standard treatment

ACTIVE COMPARATOR

Drug: Standard treatment

Interventions

Standard treatment DRUG

Standard treatment

Standard treatment

Standard treatment combined with Yiyuancong DRUG

Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals

Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (5)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Shenzhen Baoan People's Hospital

Shenzhen, Guangdong, China

RECRUITING

Xiaolan People's Hospital of Zhongshan

Zhongshan, Guangdong, China

RECRUITING

Liuzhou Worker's Hospital

Liuchow, Guangxi, China

RECRUITING

Guangdong Provincial People's Hospital Ganzhou Hospital

Ganzhou, Jiangxi, China

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sudden; Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhuoyi Chen MD

CONTACT

+86 18737552662; 18737552662@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: April 1, 2026
• Study Start: November 15, 2025
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

CN (5)