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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
96
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)
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).
Kyung Hee University Oriental Medicine Hospital
Seoul, Seoul, South Korea
RECRUITINGVisual 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).
Time frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Unstimulated Salivary Flow Rate (USFR) and Stimulated salivary flow rate (SSFR)
Time frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Residual saliva
Time frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
Salivary IgA, Chromogranin A, Cortisol
Time frame: 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
Time frame: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
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