Xerostomia
Conditions
Keywords
Xerostomia, Yukmijihwang-tang, Yin-Deficiency, Visual analogue scale, Dry mouth symptom questionnaire
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTHerbal 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)
DIETARY_SUPPLEMENTPlacebo 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).
Sponsors
Korea Health Industry Development Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) for xerostomia | Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week) | DMSQ is composed of 10 questions associated with the severity of xerostomia and various behaviors related to xerostomia |
Countries
South Korea
Contacts
Primary ContactJinsung Kim, doctorate
Backup ContactJae-Woo Park, doctorate
Outcome results
None listed