The Beneficial Effects of Pomegranate on Hearing of Patients Without Hemodialysis

NCT03575390 | Completed

• 1 other identifier: B10601002-3
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 received the above treatment for 9 months, and underwent pure tone audiometry and word discrimination scores before the start of the clinical trial and at the end of the treatment (9th month).

Conditions

Hearing Impairment

Keywords

Pomegranate; Hearing

Outcome Measures

Primary Outcomes (1)

• Pure tone audiometry (PTA)

  pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.

  9 months

Secondary Outcomes (2)

• speech reception threshold (SRT)

  9 months

• speech discrimination score (SDS)

  9 months

Study Arms (2)

control group

PLACEBO COMPARATOR

Control group will receive placebo medication therapy

Dietary Supplement: Placebo

test group

EXPERIMENTAL

pomegranate group will receive oral pomegranate (500 mg, twice per day)

Dietary Supplement: Pomegranate

Interventions

Placebo DIETARY_SUPPLEMENT

The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein.

Also known as: Maltodextrin

control group

Pomegranate DIETARY_SUPPLEMENT

Pomegranate extract 500mg

Also known as: Pomegranate extract

test group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Life can not take care of themselves or the bed of a patient.
• dialysis patients.
• Patients who can not understand the details of this study or are unable to cooperate with the examination.
• history of alcohol or drug abuse.
• history of high environmental noise exposure.
• 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).

Sponsors & Collaborators

• Dalin Tzu Chi General Hospital: lead

Study Sites (1)

Dalin Tzu Chi Hospital

Chiayi City, 66247, Taiwan

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

maltodextrin; pomegranate fruit rind

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juen-Haur Hwang, MD, PhD.

  Dalin Tzu Chi Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: July 2, 2018
• Study Start: March 30, 2018
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: September 5, 2023

Record last verified: 2023-08

Locations

TW (1)