Effect of Hericium Erinaceus on Clinical Patients With Hearing Impairment

Providence University, Taiwan

Status: Unknown

Conditions: Tinnitus

Treatments: Dietary Supplement: Placebo honey bolus; Dietary Supplement: Hericium honey bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT03632512

B10604025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 50 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Hericium honey bolus

Experimental group

Description:

Dosage form: honey bolus Dosage : Hericium erinaceus mycelium 250mg/day Frequency: 8 bolus/ day Duration: 8 months

Treatment:

Dietary Supplement: Hericium honey bolus

Control group

Placebo Comparator group

Description:

Dosage form: Placebo honey bolus Dosage : maize starch Frequency: 8 bolus/ day Duration: 8 months

Treatment:

Dietary Supplement: Placebo honey bolus