Treatment of Xerostomia by Herbal Preparation

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-11-30

Brief Summary

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The aims of this study are to investigate the effect of famous herbal formula extract on xerostomia, and to determine whether this formula affect various xerostomia-related questionnaires, salivary flow rate, residual saliva and salivary tests.

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Detailed Description

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Xerostomia is a condition related to both decrease in the amount of saliva produced and a change in its composition, therefore causing dry mouth.It can cause severe decline in quality of life and up to date, there have been few effective treatments for xerostomia.

The purpose of the current trial is to investigate the effect of herbal extract granule named Yukmijihwang-tang (YMT) on dry mouth. The trial is a randomized, double-blinded, placebo-controlled, 2-arm, 2-centered study. Ninety-six patients with xerostomia will be randomly assigned to one of the 2 groups consisting of YMT or placebo. The assigned treatments will last for 8 weeks and the follow-up period will be 2 weeks.

The primary outcomes are Visual analogue scale (VAS) for xerostomia.

The present study is designed to examine the safety and efficacy of YMT on xerostomia. Our study provides the clinical evidence of a new therapeutic strategy for xerostomia.

Conditions

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Xerostomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Yukmijihwang-tang

Yukmijihwang-tang: Real herbal extract granule

Group Type EXPERIMENTAL

Herbal extract granule

Intervention Type DIETARY_SUPPLEMENT

The herbal extract granule, Yukmijihwang-tang granule, consists of 6 herbs. Ingredients: Rehmanniae Radix, Deoscoreae Radix, Corni Fructus, Hoelen, Alismatis Radix, Paeoniae Radicis Cortex. Dosage and frequency: 1 pack (3g), 3 packs per day (2 hours after morning, afternoon and evening meal)

Yukmijihwang-tang_Placebo

Yukmijihwang-tang\_Placebo: Placebo herbal extract granule

Group Type PLACEBO_COMPARATOR

Placebo herbal extract granule

Intervention Type DIETARY_SUPPLEMENT

The Yukmijihwang-tang\_Placebo has the same form, color and flavor as experimental intervention (Yukmijihwang-tang). The dosage, frequency and duration is also the same as experimental intervention (Yukmijihwang-tang).

Interventions

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Herbal extract granule

The herbal extract granule, Yukmijihwang-tang granule, consists of 6 herbs. Ingredients: Rehmanniae Radix, Deoscoreae Radix, Corni Fructus, Hoelen, Alismatis Radix, Paeoniae Radicis Cortex. Dosage and frequency: 1 pack (3g), 3 packs per day (2 hours after morning, afternoon and evening meal)

Intervention Type DIETARY_SUPPLEMENT

Placebo herbal extract granule

The Yukmijihwang-tang\_Placebo has the same form, color and flavor as experimental intervention (Yukmijihwang-tang). The dosage, frequency and duration is also the same as experimental intervention (Yukmijihwang-tang).

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Hexalong Granule Hexalong Granule Placebo

Eligibility Criteria

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Inclusion Criteria

1. Age of 60 - 80
2. The visual analog scale for xerostomia must represent more than 4 points during 2wks prior to enrollment
3. One who has less than 0.3 ml/min of unstimulated salivary flow rate
4. One who has complained of xerostomia for at least 3months
5. One who is able to read, write, hear, see something
6. One who agree on not taking other therapies during experimental period
7. One who agree on consent form

Exclusion Criteria

1. One who is taking the treatment for autoimmune disease such as sjogren's disease, rheumatic disease, systemic lupus erythematosus etc
2. One who has the history of taking radiotherapy on head and neck or history of organ transplantation
3. One who has severe mental illness such as depression
4. One who takes oriental medicine or health functional food within 2 wks before enrollment
5. One who takes the remedies on the purpose of relieving xerostomia such as pilocarpine, cevimeline, gargle solution, frequent gum use, intra oral devices and toothpaste etc.

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No