Effect of Hericium Erinaceus on Clinical Patients With Hearing Impairment

Last updated: August 14, 2018
Sponsor: Providence University, Taiwan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Impairment

Tinnitus

Hearing Loss

Treatment

N/A

Clinical Study ID

NCT03632512
B10604025
  • Ages 50-79
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Patients with abnormal liver and kidney function, normal hearing, severe and verysevere hearing loss, no tinnitus or non-subjective sensorineural tinnitus, moderate ormore cognitive impairment , patients unable to understand the details of this study orpatients unable to co-examine, history of alcohol or drug abuse, history of highambient 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 airwaythreshold, hearing impairment before age 30, and inability to understand the detailsof this study.

Study Design

Total Participants: 80
Study Start date:
May 18, 2018
Estimated Completion Date:
June 30, 2020

Study 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.

Connect with a study center

  • Departments of Otolaryngology and Neurosurgery of Dalin Tzu Chi Hospital

    Dalin, Chiayi 622
    Taiwan

    Active - Recruiting

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