An interventional study of Herbal extract granule and Placebo herbal extract granule in Xerostomia, sponsored by Korea Health Industry Development Institute. Status unknown at 1 site in Korea, Republic of. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-05-14.
Sponsored by Korea Health Industry Development Institute · Not applicable, Interventional, and Treatment
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.
254 studies on the registry are indexed under Xerostomia; 47 are open to participants now.
This study's planned enrollment of 96 is above the median of 42 across 216 interventional studies indexed under Xerostomia.
Browse Xerostomia studies →Korea Health Industry Development Institute is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Yukmijihwang-tang: Real herbal extract granule
Dietary Supplement: Herbal extract granule
Yukmijihwang-tang_Placebo: Placebo herbal extract granule
Dietary Supplement: Placebo 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)
Also known as: Hexalong 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).
Also known as: Hexalong Granule Placebo
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).
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)
This study is status unknown, as verified in May 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Korea Health Industry Development Institute