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The Beneficial Effects of Pomegranate on Hearing of Patients Without Hemodialysis

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ClinicalTrials.gov Identifier: NCT03575390
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dalin Tzu Chi General Hospital

Brief Summary:

Pomegranate has anti-oxidative capacity. It might reduce symptoms of Alzheimer's disease, Drug-induced hepatitis, and might prevent deterioration of cardiovascular diseases and cancer progression. But, the beneficial effects of pomegranate on hearing impairment was still unclear.

This study aimed to investigate the beneficial effects of pomegranate on hearing impairment by a prospective, randomized, double-blinded clinical trial design. The investigators'll include 120 elderly patients without hemodialysis in our hospital, and divided them into 2 groups. Control group will receive placebo treatment; pomegranate group will receive oral pomegranate (500 mg, twice per day).

All patients will receive above treatment for 9 months, and receive examinations of pure tone audiometry, word discrimination score before start of this clinical trial, 4.5th month after the start day, the end of treatment (the 9th month), and 4.5 months after the treatment (the 13.5th month).


Condition or disease Intervention/treatment Phase
Hearing Impairment Dietary Supplement: Placebo Dietary Supplement: Pomegranate Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: The Beneficial Effects of Pomegranate on Hearing of Patients Without Hemodialysis: A Prospective, Randomized, Double-blinded Clinical Trial
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: control group
Control group will receive placebo medication therapy
Dietary Supplement: Placebo
The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein.
Other Name: Maltodextrin

Experimental: test group
pomegranate group will receive oral pomegranate (500 mg, twice per day)
Dietary Supplement: Pomegranate
Pomegranate extract 500mg
Other Name: Pomegranate extract




Primary Outcome Measures :
  1. Pure tone audiometry (PTA) [ Time Frame: 9 months ]
    pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.


Secondary Outcome Measures :
  1. speech reception threshold (SRT) [ Time Frame: 9 months ]
    The speech recognition threshold is the lowest hearing level at which speech can barely be recognized or understood. The SRT is defined as the lowest hearing level at which the patient correctly repeats 50% of a list of spondaic words. Examples are airplane, hot dog, outside, ice cream, and baseball. Usually a very soft level (db HL).

  2. speech discrimination score (SDS) [ Time Frame: 9 months ]
    The SDS test tool is a single syllable word list. Each table consists of 50 words, such as, look, go. The test method is to listen to the subject at a volume higher than the SRT value of 20 to 40 dB (30 dB), so that the subject repeats the spoken word sound. Based on the percentage of correct answers, normal people can repeat 95 to 100% of the words, and 80% or less of them are bad discriminating power and affect the understanding of language. SDS is usually expressed in %.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 50 to 80 years old.
  2. non-renal dialysis patients.

Exclusion Criteria:

  1. Life can not take care of themselves or the bed of a patient.
  2. dialysis patients.
  3. Patients who can not understand the details of this study or are unable to cooperate with the examination.
  4. history of alcohol or drug abuse.
  5. history of high environmental noise exposure.
  6. The pure tone hearing threshold is greater than 10 decibel (dB), and the audiogram 4 kilohertz (kHz) air conduction threshold is greater than 8 kilohertz (kHz) air threshold value of 20 decibel (dB).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575390


Contacts
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Contact: Juen-Haur Hwang, MD, PhD. +886-5-2648000 ext 5239 juenhaur@ms96.url.com.tw

Locations
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Taiwan
Dalin Tzu Chi Hospital Recruiting
Chiayi City, Taiwan, 66247
Contact: Juen-Haur Hwang, MD, PhD.    +886-5-2648000 ext 5239    juenhaur@ms96.url.com.tw   
Sponsors and Collaborators
Dalin Tzu Chi General Hospital
Investigators
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Study Chair: Juen-Haur Hwang, MD, PhD. Dalin Tzu Chi Hospital

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Responsible Party: Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT03575390     History of Changes
Other Study ID Numbers: B10601002-1
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dalin Tzu Chi General Hospital:
Pomegranate
Hearing
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms