Treatment of Xerostomia by Herbal Preparation

Study Overview
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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.

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.

Official Title
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Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized,Double-blind, Placebo-controlled, Two-center Trial

Conditions
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Xerostomia

Intervention / Treatment
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* Dietary Supplement: Herbal extract granule
* Dietary Supplement: Placebo herbal extract granule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 60 - 80 The visual analog scale for xerostomia must represent more than 4 points during 2wks prior to enrollment One who has less than 0.3 ml/min of unstimulated salivary flow rate One who has complained of xerostomia for at least 3months One who is able to read, write, hear, see something One who agree on not taking other therapies during experimental period One who agree on consent form Exclusion Criteria: One who is taking the treatment for autoimmune disease such as sjogren's disease, rheumatic disease, systemic lupus erythematosus etc One who has the history of taking radiotherapy on head and neck or history of organ transplantation One who has severe mental illness such as depression One who takes oriental medicine or health functional food within 2 wks before enrollment 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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yukmijihwang-tang<br>Yukmijihwang-tang: Real herbal extract granule | Dietary Supplement: Herbal extract granule<br>* 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)<br>* Other names: Hexalong Granule;|
| Placebo Comparator: Yukmijihwang-tang_Placebo<br>Yukmijihwang-tang_Placebo: Placebo herbal extract granule | Dietary Supplement: Placebo herbal extract granule<br>* 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).<br>* Other names: Hexalong Granule Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) for xerostomia | A 100 mm measurement instrument will be given to the patient and he will be instructed to indicate his severity of xerostomia in relation to the 2 extremes (0: no fatigue, 100: very severe fatigue). | Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unstimulated Salivary Flow Rate (USFR) and Stimulated salivary flow rate (SSFR) |  | Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week) | 
| Residual saliva |  | Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week) | 
| Salivary IgA, Chromogranin A, Cortisol |  | Visit 1(0week), Visit 3(8week) | 
| Dry Mouth Symptom Questionnaire(DMSQ) | DMSQ is composed of 10 questions associated with the severity of xerostomia and various behaviors related to xerostomia | Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xerostomia, Yukmijihwang-tang, Yin-Deficiency, Visual analogue scale, Dry mouth symptom questionnaire