A Randomized Controlled Trial Evaluating the Effectiveness of a Salvia-based Mouthwash in Palliative Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-12

Study Completion Date

2016-09-08

Brief Summary

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This study examines the effectiveness of an herbal mouthwash made from salvia in maintaining good oral health among patients in palliative care. It is hypothesized that using the mouthwash made from salvia will result in better oral health and more oral comfort than using with conventional normal saline mouthwash.

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Detailed Description

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The aim of this study is to examine the effectiveness of an herbal mouthwash made from salvia officinalis (SO) in maintaining good oral health among patients in palliative care. The study compares a mouthwash based on salvia tea solution with conventional normal saline mouthwash and addresses the following research questions:

1. Does the SO-based mouthwash provide a better treatment than conventional normal saline in maintaining good oral health in terminally ill patients?
2. Is there a difference in the individual perception of oral comfort in patients receiving SO versus patients receiving saline rinsing solution?

Conditions

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Terminal Illness Xerostomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Salvia

Salvia mouthwash used 4 times per day for 4 days

Group Type EXPERIMENTAL

Salvia mouthwash

Intervention Type OTHER

Saline

Saline mouthwash used 4 times per day for 4 days.

Group Type ACTIVE_COMPARATOR

Saline mouthwash

Intervention Type OTHER

Interventions

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Saline mouthwash

Intervention Type OTHER

Salvia mouthwash

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Attending bedded unit at Hospice
* Over 18 years of age and able to provide written formal consent
* Diagnosed with advanced cancer
* Patient with positive response when asked if they experience oral discomfort or complications.

Exclusion Criteria

* Estimated life expectancy prognosis of less than 2 weeks
* Significant cognitive impairment
* Current use of antifungal medication
* Currently receiving radiation therapy or chemotherapy
* Epileptic
* Diabetic

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No