Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorGuangdong Provincial People's Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard treatment combined with Yiyuancong
DrugStandard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals
Standard treatment
DrugStandard treatment
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after mealsExperimental treatment 1 intervention
Group B: Standard treatmentActive comparator 1 intervention
Trial outcomes
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.
Time frame
baseline (day of enrollment), and Day 7, Month 1, and Month 2 post-treatment.Secondary outcomes
1
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.2
complete blood count (CBC)
Time frame
baseline, and Day 7, Month 1, and Month 2 post-treatment.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov