Clinical trial NCT03632512: Effect of Hericium Erinaceus on Clinical Patients With Hearing Impairment
Official title: Effect of Hericium Erinaceus on Clinical Patients With Hearing Impairment and Possible Mechanisms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus
Keywords: Hericium erinaceus
Hearing
Lead sponsor: Providence University, Taiwan
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to investigate the effect of Hericium Erinaceus on clinical patients with hearing impairment and possible mechanisms. Subjects with hearing impairment will be enrolled and randomly divided into experimental or control group supplemented with Hericium Erinaceus (430 mg/kg/day) or placebo, respectively for eight months. Basic characteristics will be evaluated at baseline by questionnaire. The hearing, liver and kidney functions, and neurotrophic factors will be examined at baseline, 4th month and 8th month.

Detailed description: This study aims to investigate the effect of Hericium Erinaceus on clinical patients with hearing impairment and possible mechanisms. Subjects with hearing impairment will be enrolled. Inclusion criteria were 50 to 79 years old with symmetric sensorineural hearing loss, subjective sensorineural tinnitus, and all frequencies differed of ears less than 15 dB. Exclusion conditions were patients with abnormal liver and kidney function, normal hearing, severe and very severe hearing loss, no tinnitus or non-subjective sensorineural tinnitus, moderate or more cognitive impairment, patients unable to understand the details of this study or patients unable to co-examine, history of alcohol or drug abuse, history of high ambient noise exposure, bone tone air gap of pure tone hearing threshold greater than 10 dB, and audiogram 4 kHz air conduction threshold greater than 8 kHz, 20 dB airway threshold, hearing impairment before age 30, and inability to understand the details of this study. Participants will randomly divide into experimental or control group supplemented with Hericium Erinaceus (430 mg/kg/day) or placebo, respectively for eight months by a prospective, randomized, double-blind approach. Basic characteristics will be evaluated at baseline by questionnaire. The status of hearing, and CBC, GOT, GPT, BUN, Creatinine, NGF and BDNF expressions in blood will be examined at baseline, 4th month and 8th month.

Eligibility criteria: Inclusion Criteria:

* Patients aged 50 to 79 years old with symmetric sensorineural hearing loss, subjective sensorineural tinnitus, and all frequencies differed of ears less than 15 dB.

Exclusion Criteria:

* Patients with abnormal liver and kidney function, normal hearing, severe and very severe hearing loss, no tinnitus or non-subjective sensorineural tinnitus, moderate or more cognitive impairment , patients unable to understand the details of this study or patients unable to co-examine, history of alcohol or drug abuse, history of high ambient noise exposure, bone tone air gap of pure tone hearing threshold greater than 10 dB, and audiogram 4 kHz air conduction threshold greater than 8 kHz, 20 dB airway threshold, hearing impairment before age 30, and inability to understand the details of this study.

Primary outcomes:
measure: 1.Change of Tinnitus status evaluates by Tinnitus handicap inventory (THI)
timeFrame: Baseline, 4th month and 8th month
measure: Change of Tinnitus severity evaluates by visual analog scale (VAS)
timeFrame: Baseline, 4th month and 8th month
measure: Changes of hearing obstacle average measure by Pure Tone Audiometry(PTA)
timeFrame: Baseline, 4th month and 8th month
measure: Changes of speech recognizing measure by Speech Audiometry.
timeFrame: Baseline, 4th month and 8th month
measure: Changes of NGF and BDNF levels of blood investigate by enzyme-linked immunosorbent assay (ELISA)
timeFrame: Baseline, 4th month and 8th month
Secondary outcomes:
Other outcomes:
Locations:
city: Dalin
country: Taiwan
facility: Departments of Otolaryngology and Neurosurgery of Dalin Tzu Chi Hospital
state: Chiayi
Study officials:
affiliation: Providence University
name: Yin-Ching Chan
role: STUDY_CHAIR
References: