Xerostomia Clinical Trial
Official title:
Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized,Double-blind, Placebo-controlled, Two-center Trial
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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