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
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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|
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
- Pure tone audiometry (PTA) [ Time Frame: 9 months ]pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.
- 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).
- 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 %.
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
|Contact: Juen-Haur Hwang, MD, PhD.||+886-5-2648000 ext email@example.com|
|Dalin Tzu Chi Hospital||Recruiting|
|Chiayi City, Taiwan, 66247|
|Contact: Juen-Haur Hwang, MD, PhD. +886-5-2648000 ext 5239 firstname.lastname@example.org|
|Study Chair:||Juen-Haur Hwang, MD, PhD.||Dalin Tzu Chi Hospital|