Trial | NCT03632512  Report issue

Title

Effect of Hericium Erinaceus on Clinical Patients With Hearing Impairment
Effect of Hericium Erinaceus on Clinical Patients With Hearing Impairment and Possible Mechanisms

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    80
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.
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.
Study Started
May 18
2018
Primary Completion
Jan 17
2019
Anticipated
Study Completion
Jun 30
2020
Anticipated
Last Update
Aug 15
2018

Dietary Supplement Hericium honey bolus

The subjects of the experimental group will be supplemented with Hericium Erinaceus honey bolus(430 mg/kg/day) for eight months.

Dietary Supplement Placebo honey bolus

The subjects of the control group will be supplemented with Placebo honey bolus(8 bolus/ day) for 8 months.

Hericium honey bolus Experimental

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

Control group Placebo Comparator

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

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.
No Results Posted