Frontiers in pharmacology · 2026
Adjunctive Acorus tatarinowii essential-oil ear-canal packing for idiopathic sudden sensorineural hearing loss: study protocol for a single-center, randomized, double-blind, placebo-controlled clinical trial.
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Chen Sibei, Xu Handong, He Xiao, Tang Xuxia
Аннотация
BACKGROUND: Idiopathic sudden sensorineural hearing loss (ISSNHL) is an acute otologic emergency, and hearing recovery remains highly variable and frequently unsatisfactory. Acorus tatarinowii Schott has long been used in traditional Chinese medicine to treat hearing impairment and related auditory disorders. Its essential oil (SCP-oil) has demonstrated anti-inflammatory, antioxidant, and neuroprotective activities in preclinical studies. Advances in local otologic drug-delivery strategies suggest that administration through the external auditory canal may offer a practical, noninvasive approach to local treatment. This study therefore aims to evaluate the efficacy and safety of adjunctive SCP-oil ear-canal packing in patients with ISSNHL.
METHODS AND ANALYSIS: This is a single-center, randomized, double-blind, placebo-controlled clinical trial to be conducted at Zhejiang Provincial Hospital of Chinese Medicine. The trial has been registered with the International Traditional Medicine Clinical Trial Registry (ITMCTR2026000919). A total of 258 eligible participants will be randomly assigned in a 1:1 ratio to receive conventional therapy combined with either SCP-oil ear-canal packing or glycerin placebo ear-canal packing for 14 consecutive days. The primary outcome is the study-defined total markedly effective rate of hearing recovery at week 2, defined as the proportion of participants achieving complete recovery or marked improvement, as assessed by pure-tone audiometry. Secondary outcomes include the mean improvement in hearing thresholds across the affected frequencies, the hearing-recovery categories, tinnitus severity measured using the Visual Analog Scale (VAS), depressive symptoms assessed using the Self-Rating Depression Scale (SDS), and sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Efficacy outcomes will be assessed at baseline and week 2, with an additional safety assessment conducted at week 4. Adverse events will be monitored throughout the study.
DISCUSSION: This trial will provide evidence on the efficacy, safety, and tolerability of adjunctive SCP-oil ear-canal packing for ISSNHL, including its effects on hearing recovery and patient-reported outcomes. The findings may also inform the design of future multicenter clinical trials.
METHODS AND ANALYSIS: This is a single-center, randomized, double-blind, placebo-controlled clinical trial to be conducted at Zhejiang Provincial Hospital of Chinese Medicine. The trial has been registered with the International Traditional Medicine Clinical Trial Registry (ITMCTR2026000919). A total of 258 eligible participants will be randomly assigned in a 1:1 ratio to receive conventional therapy combined with either SCP-oil ear-canal packing or glycerin placebo ear-canal packing for 14 consecutive days. The primary outcome is the study-defined total markedly effective rate of hearing recovery at week 2, defined as the proportion of participants achieving complete recovery or marked improvement, as assessed by pure-tone audiometry. Secondary outcomes include the mean improvement in hearing thresholds across the affected frequencies, the hearing-recovery categories, tinnitus severity measured using the Visual Analog Scale (VAS), depressive symptoms assessed using the Self-Rating Depression Scale (SDS), and sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Efficacy outcomes will be assessed at baseline and week 2, with an additional safety assessment conducted at week 4. Adverse events will be monitored throughout the study.
DISCUSSION: This trial will provide evidence on the efficacy, safety, and tolerability of adjunctive SCP-oil ear-canal packing for ISSNHL, including its effects on hearing recovery and patient-reported outcomes. The findings may also inform the design of future multicenter clinical trials.